Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis

Arthritis, Psoriatic Clinical Trial

— OPAL BALANCE  

Official title:

A LONG-TERM, OPEN-LABEL EXTENSION STUDY OF TOFACITINIB (CP-690,550) FOR THE TREATMENT OF PSORIATIC ARTHRITIS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01976364
• Other study ID #: A3921092
• Secondary ID: 2011-002169-39OP
• Status: Completed
• Phase: Phase 3
• Start date: February 17, 2014
• Est. completion date: May 20, 2019

Study information

• Verified date: May 2020
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 3, long-term open-label extension study to evaluate the safety, tolerability and efficacy of tofacitinib in subjects with active PsA who have previously participated in randomized studies of tofacitinib for this indication.

This study will include a sub-study to evaluate the efficacy, safety and tolerability of tofacitinib 5 mg BID administered as monotherapy after methotrexate withdrawal compared to tofacitinib 5 mg BID continued in combination with methotrexate. The sub-study will be available to subjects who have completed at least 24 months of participation in the open-label extension study and meet eligibility criteria for the sub-study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 686
• Est. completion date: May 20, 2019
• Est. primary completion date: May 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Previous participation in qualifying PsA study involving tofacitinib

Exclusion Criteria:

• Time from End of Study visit of qualifying study is >3 months.

• Pregnant female, breastfeeding female or female of childbearing potential unwilling or unable to use highly effective birth control for duration of study and one ovulatory cycle thereafter.

Sub-study Inclusion Criteria:

• Subjects who have completed at least 24 months of treatment with tofacitinib in the extension study

• Subjects on a stable oral dose of methotrexate (maximum dose 20 mg per week)

Sub-study Exclusion Criteria:

-Subjects who are receiving methotrexate by a route other than oral

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic

Intervention

Drug:
• Tofacitinib
Tofacitinib 5 mg tablet twice daily
• Tofacitinib
Tofactinib 10 mg tablet twice daily
• Methotrexate
Methotrexate 7.5-20 mg weekly
• Placebo Methotrexate
Placebo to match active methotrexate orally once a week

Locations

Country	Name	City	State
Australia	Emeritus Research	Camberwell	Victoria
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	St. Vincent's Hospital	Fitzroy	Victoria
Australia	St. Vincent's Hospital (Melbourne)	Fitzroy	Victoria
Australia	Rheumatology Research Unit	Maroochydore	Queensland
Australia	Pacific Private Clinic	Southport	Queensland
Belgium	Hopital Erasme - Clinique Universitaire de Bruxelles	Brussels	Brabant Flamand
Belgium	Hopital Erasme - Clinique Universitaire de Bruxelles	Brussels
Belgium	Reumaclinic	Genk
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	University Hospital Leuven	Leuven
Belgium	ZNA Jan Palfijn	Merksem
Brazil	EDUMED - Educação em Saùde SS Ltda	Curitiba	PR
Brazil	CMIP- Centro Mineiro de Pesquisa Ltda/CETAL- Centro de Estudos e Tratamento do Aparelho Locomotor	Juiz de Fora	MG
Brazil	Hospital de Clinicas de Porto Alegre (HCPA) / UFRGS	Porto Alegre	RS
Bulgaria	UMHAT "Dr. G. Stranski" EAD, Department of Rheumatology	Pleven
Bulgaria	Multiprofile Hospital for Active Treatment - Plovdiv AD	Plovdiv
Bulgaria	Multiprofile hospital for active treatment Kaspela EOOD	Plovdiv
Bulgaria	Medical Center - "New rehabilitation center" EOOD	Stara Zagora
Canada	K. Papp Clinical Research	Waterloo	Ontario
Czechia	Revmacentrum MUDr. Mostera, s.r.o.	Brno
Czechia	Revmatologie s.r.o.	Brno
Czechia	Stavovska, s.r.o.	Brno
Czechia	X-Medica, s.r.o.	Brno
Czechia	Vesalion s.r.o.	Ostrava
Czechia	Revmatologicky ustav	Praha 2
Czechia	Revmatologicky ustav - Lekarna	Praha 2
Czechia	Revmatologicka ambulance	Praha 4
Czechia	MEDICAL PLUS, s.r.o.	Uherske Hradiste
Germany	Rheumazentrum Prof. Dr. med Gunther Neeck	Bad Doberan	Mecklenburg-vorp
Germany	Charite Universitaetsmedizin Berlin	Berlin
Germany	Klinische Forschung Berlin-Mitte GmbH	Berlin
Germany	Rheumapraxis Steglitz	Berlin
Germany	Schlosspark-Klinik	Berlin
Germany	CIRI, Centrum fuer innovative Diagnostik und Therapie Rheumatologie und Immunologie (GmbH)	Frankfurt am Main
Germany	Medizinische Universitaetsklinik Freiburg	Freiburg
Germany	Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes	Homburg
Germany	University Hospital of Cologne	Koeln
Germany	Elisabeth Klinik Bigge	Olsberg
Hungary	Budapest Fovaros II. keruleti Onkormanyzat Egeszsegugyi Szolgalata- Rontgen- Ultrahang	Budapest
Hungary	Diagnoscan Magyarország Kft.	Budapest
Hungary	Magyar Honvedseg Egeszsegugyi Kozpont - Kozponti Radiologiai Diagnosztika Osztaly	Budapest
Hungary	Magyar Honvedseg Egeszsegugyi Kozpont, Reumatologiai Osztaly	Budapest
Hungary	Qualiclinic Kft.	Budapest
Hungary	Revita Reumatologiai Rendelo	Budapest
Hungary	Csolnoky Ferenc Korhaz	Veszprem
Hungary	Csolnoky Ferenc Korhaz, Reumatologiai Osztaly	Veszprem
Mexico	Christus Muguerza del Parque S.A. de C.V.	Chihuahua
Mexico	Investigacion y Biomedicina de Chihuahua SC	Chihuahua
Mexico	Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C.	Culiacan	Sinaloa
Mexico	Hospital General de Culiacan Dr. Bernardo J. Gastelum	Culiacan	Sinaloa
Mexico	Sanatorio CEMSI Chapultepec	Culiacan	Sinaloa
Mexico	Centro Integral en Reumatologia S.A. de C.V.	Guadalajara	Jalisco
Mexico	Centro Multidisciplinario Para El Desarrollo Especializado De La Investigacion Clinica En	Merida	Yucatan
Mexico	Instituto Medico Panamericano, S.A de C.V.	Merida	Yucatan
Mexico	Unidad Reumatologica Las Americas S.C.P.	Merida	Yucatan
Mexico	Cliditer, S.A. DE C.V.	Mexico City	Distrito Federal
Mexico	Grupo Medico Camino S.C.	Mexico City	Distrito Federal
Mexico	Hospital Angeles Clinica Londres	Mexico City	D.F
Poland	ClinicMed Daniluk, Nowak Spolka Jawna	Bialystok
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Chirurgiczna dla Dzieci "PriamaMed" Sp.P.	Bialystok
Poland	Zdrowie Osteo-Medic s.c. L. i A. Racewicz, A. i J. Supronik	Bialystok
Poland	Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy	Bydgoszcz
Poland	Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka partnerska	Elblag
Poland	Centrum Radiologii	Elblag
Poland	NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela	Elblag
Poland	Wojewodzki Szpital Zespolony, Zaklad Radiologii	Elblag
Poland	Przychodnia Specjalistyczna Lekarskiej Spoldzielni Pracy "Medica"	Grodzisk Mazowiecki
Poland	Specjalistyczne Gabinety Lekarskie "DERMED" Anna Kaszuba	Lodz
Poland	Top-Medical Sp. z o. o.	Lublin
Poland	Zespol Poradni Specjalistycznych Reumed Filia Onyksowa	Lublin
Poland	NZOZ Lecznica MAK-MED s.c.	Nadarzyn
Poland	Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj	Poznan
Poland	NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu	Torun
Poland	Centrum Medyczne Pratia S.A. Warszawa	Warszawa	Mazowieckie
Poland	Reumatika Centrum Reumatologii NZOZ	Warszawa
Poland	Rheuma-Medicus Zaklad Opieki Zdrowotnej	Warszawa
Poland	Synexus Polska Oddzial we Wroclawiu	Wroclaw
Russian Federation	State Autonomic Healthcare Institution ''City Clinical Hospital # 7''	Kazan	Republic OF Tatarstan
Russian Federation	SBIH of Moscow "City Clinical Hospital #1 n. a. N.I. Pirogov" of the Healthcare Department of Moscow	Moscow
Russian Federation	Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"	Novosibirsk
Russian Federation	Research Institution of Fundamental and Clinical Immunology	Novosibirsk
Russian Federation	Regional State Budgetary Health Care Institution of Karelia Republic	Petrozavodsk
Russian Federation	State Institution of Healthcare Regional Clinical Hospital	Saratov
Russian Federation	State Budget Educational Institution of Highest Professional Education	Tomsk
Russian Federation	State Autonomous Healthcare lnstitution of Yaroslavl Region "Clinical Hospital of Emergency Medical	Yaroslavl
Russian Federation	State Healthcare Institution of Yaroslavl Region Clinical Emergency Hospital n.a.N.V. Solovyev	Yaroslavl
Slovakia	Nestatna reumatologicka ambulancia	Bratislava
Slovakia	MEDMAN s.r.o. - reumatologicka ambulancia	Martin
Slovakia	REUMEX, s.r.o	Rimavska Sobota
Spain	Complexo Hospitalario Universitario A Coruna	A Coruna
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Corporacio Sanitaria Parc Tauli	Sabadell	Barcelona
Spain	Hospital Universitario Marques de Valdecilla	Santander	Cantabria
Spain	Hospital Clinico de Santiago	Santiago de Compostela	A Coruna
Spain	Hospital Quiron Salud Infanta Luisa	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Universitario y Politecnico La Fe	Valencia
Taiwan	Buddhist Dalin Tzu Chi General Hospital	Chia-Yi
Taiwan	Chang Gung Medical Foundation-Kaohsiung Branch	Kaohsiung City
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	Taipei Veterans General Hospital	Taipei
United Kingdom	Royal United Hospitals NHS Foundation Trust	Bath
United Kingdom	Bradford Royal lnfirmary, BTHFT	Bradford	WEST Yorkshire
United Kingdom	Bradford Teaching Hospitals NHS Foundation Trust	Bradford	WEST Yorkshire
United Kingdom	The Dudley Group NHS Foundation Trust	Dudley	WEST Midlands
United Kingdom	Barking Havering and Redbridge University Hospital NHS Trust-King George Hospital	Goodmayes	Essex
United Kingdom	Barking Havering and Redbridge University Hospitals NHS Trust	Romford	Essex
United Kingdom	Wirral University Teaching Hospital NHS Foundation Trust	Upton	Wirral
United Kingdom	York Teaching Hospital NHS Foundation Trust	York
United States	East Penn Rheumatology Associates, PC	Bethlehem	Pennsylvania
United States	Rheumatology Associates, PC	Birmingham	Alabama
United States	St. Luke's Clinic - Rheumatology	Boise	Idaho
United States	St. Luke's Intermountain Research Center	Boise	Idaho
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	New England Research Associates, LLC	Bridgeport	Connecticut
United States	Cincinnati Rheumatic Disease Study Group, Inc.	Cincinnati	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	University Hospitals of Cleveland Medical Center	Cleveland	Ohio
United States	Adriana Pop-Moody MD Clinic PA	Corpus Christi	Texas
United States	Pioneer Research Solutions, Inc.	Cypress	Texas
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	St. Paul Rheumatology, P.A.	Eagan	Minnesota
United States	St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare	Fullerton	California
United States	Arizona Arthritis & Rheumatology Associates, P.C.	Glendale	Arizona
United States	Klein and Associates, M.D., P.A.	Hagerstown	Maryland
United States	Rheumatology Associates of North Alabama, PC	Huntsville	Alabama
United States	Arthritis Clinic	Jackson	Tennessee
United States	West Tennessee Research Institute	Jackson	Tennessee
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Bluegrass Community Research, Inc.	Lexington	Kentucky
United States	Physician Research Collaboration, LLC	Lincoln	Nebraska
United States	Paramount Medical Research & Consulting, LLC	Middleburg Heights	Ohio
United States	Rheumatology Associates of Central Florida, PA	Orlando	Florida
United States	Millennium Research	Ormond Beach	Florida
United States	Desert Medical Advances	Palm Desert	California
United States	Arthritis Center, Inc.	Palm Harbour	Florida
United States	Guillermo Valenzuela, MD PA dba Integral Rheumatology & Immunology Specialists	Plantation	Florida
United States	Clayton Medical Research	Saint Louis	Missouri
United States	Investigational Drug Services	Salt Lake City	Utah
United States	University of Utah Hospital & Clinics	Salt Lake City	Utah
United States	University of Utah Hospitals and Clinics - Clinie 2	Salt Lake City	Utah
United States	San Diego Arthritis Medical Clinic	San Diego	California
United States	Seattle Rheumatology Associates	Seattle	Washington
United States	Swedish Medical Center	Seattle	Washington
United States	Swedish Medical Center	Seattle	Washington
United States	Stanford Anatomic Pathology and Clinical Lab	Stanford	California
United States	Stanford Health Care Department of Pharmacy lnvestigational Drug Services	Stanford	California
United States	Stanford University Hospitals and Clinics	Stanford	California
United States	Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology	Summerville	South Carolina
United States	The Center for Rheumatology and Bone Research	Wheaton	Maryland
United States	Clinical Pharmacology Study Group	Worcester	Massachusetts
United States	Florida Medical Clinic, P.A.	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  Czechia,  Germany,  Hungary,  Mexico,  Poland,  Russian Federation,  Slovakia,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 48 months that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.	Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)
Primary	Number of Adverse Events (AEs) by Severity	An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified into 3 categories according to their severity as mild AEs (did not interfere with participant's usual function), moderate AEs (interfered to some extent with participant's usual function) and severe AEs (interfered significantly with participant's usual function).	Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)
Primary	Number of Participants With Abnormal Clinical Laboratory Values	Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes,neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin [total, direct, indirect], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids (cholesterol, HDL, LDL, triglyceride, apolipoprotein [A-1, B]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy (urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Laboratory abnormality: determined by investigator per pre-defined criteria.	Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)
Primary	Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values	Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes, neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin[total,direct,indirect], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids(cholesterol, HDL, LDL, triglyceride, apolipoprotein [A-1, B]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine-pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy(urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Clinically significant change: determined by investigator per pre-defined criteria.	Date of first dose of study medication (Baseline) up to 48 months (36 months of main study and 12 months of sub-study)
Primary	Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6	HAQ-DI assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible HAQ-DI score ranged from 0 (least difficulty) to 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities.	Sub-study: Baseline (Day 1), Month 6
Primary	Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6	PASDAS was composite PsA disease activity score that included following components: Physician and patient global assessment of disease activity (assessed on a 0-100 VAS) in millimeter (mm), swollen (66 joints) and tender joint counts (68 joints), Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6), tender dactylitic digit score (scored on a scale of 0-3, where 0= no tenderness and 3= extreme tenderness), short form-36 questionnaire (SF-36) physical component summary (norm-based domain scores were used in analyses; with a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity) and C-reactive protein (CRP) in milligram per liter (mg/L). PASDAS was composite score and was a weighted index with score range of 0 to 10, where higher score indicated more severe disease.	Sub-study: Baseline (Day 1), Month 6
Secondary	Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response	Participants with 20% improvement from baseline in tender and swollen joint counts and 20% improvement in at least 3 of the 5 measures: Patient's global assessment of arthritis (PtGA), Physician's global assessment of arthritis (PhyGA), participant's assessment of arthritis pain, HAQ-DI and C-reactive protein (CRP) in mg/L. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.	Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary	Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response	Participants with 50% improvement from baseline in tender and swollen joint counts and 50% improvement in at least 3 of the 5 measures: PtGA, PhyGA, participant's assessment of arthritis pain, HAQ-DI and CRP in mg/L. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.	Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary	Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response	Participants with 70% improvement from baseline in tender and swollen joint counts and 70% improvement in at least 3 of the 5 measures: PtGA, PhyGA, participant's assessment of arthritis pain, HAQ-DI and CRP in mg/L. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.	Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary	Main Study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	HAQ-DI assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain score and divided by the number of domains answered. Total possible HAQ-DI score range 0 (least difficulty) and 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities.	Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary	Main Study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)	PsARC is comprised of 4 clinical improvement criteria: greater than or equal to (>=) 20% improvement in PhyGA (VAS), >=20% improvement in PtGA; and >= 30% reduction in the number of tender joints; and >=30% reduction in the number of swollen joints. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. To achieve a clinical response, the participant must improve in 2 of the 4 PsARC criteria, 1 of which has to be the number of tender or swollen joints and none of the 4 score could worsen.	Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary	Main Study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score Greater Than [>]0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	The PGA-PsO was a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0-4). Higher score indicated higher disease severity. Severity score for each erythema, induration and scaling were summed and averaged after which the total average was rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0= clear, except for any residual discoloration, 1= almost clear, 2= mild, 3= moderate, 4= severe).	Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary	Main Study: Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Score (For Participants With Baseline Body Surface Area [BSA]>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	PASI: combined assessment of lesion severity and body area affected into single score; range =0 (no disease) -72 (maximal disease). Higher score representing greater severity of psoriasis. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks). For each section % area of skin involved was estimated: 0 (0%) - 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1 =slight, 2 =moderate, 3 =marked, 4 =very marked. Final PASI =sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4). PASI75: at least a 75 % reduction in PASI relative to Baseline.	Main study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary	Main Study: Percent Change From Baseline in PASI Composite Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Higher score representing greater severity of psoriasis. PASI is a composite scoring by investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks). For each section % area of skin involved was estimated: 0(0%) - 6(90-100%) & severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).	Main study: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary	Main Study: Percent Change From Baseline in PASI Clinical Signs Component Score (For Participants With Baseline BSA>=3% and Baseline PASI Score >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	PASI: combined assessment of lesion severity & area affected into single score; range=0(no disease)-72(maximal disease). Higher score representing greater severity of psoriasis. PASI is a composite scoring by investigator of degree of clinical sign components for erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk including axillae and groin, and lower limbs including buttocks). For each section % area of skin involved was estimated: 0(0%) - 6(90-100%) and severity estimated by clinical signs components for erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section*area score*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4).	Main study: Baseline(Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary	Main Study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS Greater Than [>] 0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis was scored on a scale of 0-3, where 0 =no tenderness and 3 =extreme tenderness in each digit of the hands and feet. The range of total dactylitis severity score for a participant was 0-60. Higher score indicated greater severity.	Main study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary	Main Study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis.	Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary	Main Study: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index (For Participants With Baseline SPARCC Enthesitis Index >0) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	The SPARCC enthesitis index identifies the presence or absence of tenderness at 16 enthesial sites, including (right and left): medial epicondyle humerus, lateral epicondyle humerus, supraspinatus insertion into greater tuberosity of humerus, greater trochanter, quadriceps insertion into superior border of patella, patellar ligament insertion into inferior pole of patella or tibial tubercle, Achilles tendon insertion into calcaneum and plantar fascia insertion into calcaneum. On examination, tenderness was recorded as present (1) or absent (0) for each of the 16 sites, with an overall total score ranging from 0 to 16. Higher score indicated a greater number of sites that are affected by enthesitis.	Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary	Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >0 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	BASDAI was a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a VAS of 0-10 cm (0= none and 10= very severe) participants answered 6 questions pertaining to 5 symptoms including fatigue, spinal pain, joint pain/swelling, areas of localized tenderness and morning stiffness. The final BASDAI score was an average of answers to 6 questions, with an overall possible score range of 0 to 10 centimeter (cm) with higher score represented more severe ankylosing spondylitis disease activity.	Main study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary	Main Study: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score (For Participants With Presence of Spondylitis at Screening and Baseline BASDAI Score >=4 cm) at Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36	BASDAI was a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a VAS of 0-10 cm (0= none and 10= very severe) participants answered 6 questions pertaining to 5 symptoms including fatigue, spinal pain, joint pain/swelling, areas of localized tenderness and morning stiffness. The final BASDAI score was an average of answers to 6 questions, with an overall possible score range of 0 to 10 cm with higher score represented more severe ankylosing spondylitis disease activity.	Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
Secondary	Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 6, 12, 18, 24, 30 and 36	The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 8 health domains were aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Norm-based domain scores, PCS and MCS scores were used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represented better physical health status.	Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary	Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 6, 12, 18, 24, 30, and 36	The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status.	Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary	Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36	SF-36v2 was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 10 items of the physical functioning scale represented levels and kinds of limitations between extremes of physical activities, including lifting and carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence and extent of physical limitations using a 3-level response continuum. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represented better physical functioning.	Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary	Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role-Physical Domain Score at Months 1, 6, 12, 18, 24, 30, and 36	SF-36v2 acute was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 4-item role-physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; & d) accomplishing less. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represented better role-physical functioning.	Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary	Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 6, 12, 18, 24, 30, and 36	The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represented less bodily pain.	Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary	Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36	The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The general health scale consisted of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher general health domain score represented better general health perceptions.	Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary	Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 6, 12, 18, 24, 30, and 36	The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher vitality domain score represents better vitality.	Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary	Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 6, 12, 18, 24, 30, and 36	The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 2-item social functioning scale assessed health-related effects on quantity and quality of social activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher social functioning domain score represented better social functioning.	Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary	Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Role-Emotional Domain Score at Months 1, 6, 12, 18, 24, 30, and 36	The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 3-item role-emotional scale assessed mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher role-emotional domain score represented better role-emotional functioning.	Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary	Main Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2 ) Mental Health Domain Score at Months 1, 6, 12, 18, 24, 30, and 36	The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher mental health domain score represented better mental health functioning.	Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary	Main Study: Change From Baseline in EuroQol- 5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 6, 12, 18, 24, 30 and 36	EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L mobility domain score were reported in this outcome measure.	Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30 and 36
Secondary	Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 6, 12, 18, 24, 30 and 36	EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L self-care domain score were reported in this measure.	Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary	Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 6, 12, 18, 24, 30 and 36	EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L usual activities domain score were reported in this measure.	Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary	Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain at Months 1, 6, 12, 18, 24, 30 and 36	EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L pain/discomfort domain score were reported in this measure.	Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary	Main Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 6, 12, 18, 24, 30 and 36	EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression). The status of each dimension had 3 possible responses (1 =no problem, 2 =some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L anxiety/depression domain score were reported in this outcome measure.	Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary	Main Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 6, 12, 18, 24, 30 and 36	The EQ VAS recorded the participant's self-rated health on a vertical VAS as standard vertical 0 (worst imaginable health state) to 100 mm (best imaginable health state) (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher score indicated a better health state.	Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary	Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 6, 12, 18, 24, 30 and 36	FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52):calculated by summing 13 items,higher score indicated lower level of fatigue, better participant status. All responses were added with equal weight to get total score.	Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary	Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 6, 12, 18, 24, 30 and 36	FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue, better participant status):calculated by summing 13 items, all responses were added with equal weight to get total score.	Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary	Main Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 6, 12, 18, 24, 30, and 36	FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue, better participant status):calculated by summing 13 items, all responses were added with equal weight to get total score.	Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
Secondary	Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 9 and 12	HAQ-DI assessed the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain score and divided by the number of domains answered. Total possible HAQ-DI score range 0 (least difficulty) and 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities.	Sub-study: Baseline (Day 1), Months 1, 3, 9 and 12
Secondary	Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Months 1, 3, 9 and 12	PASDAS was composite PsA disease activity score that included following components: Physician and patient global assessment of disease activity (assessed on a 0-100 VAS) in mm, swollen (66 joints) and tender joint counts (68 joints), Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6), tender dactylitic digit score (scored on a scale of 0-3, where 0= no tenderness and 3= extreme tenderness), SF-36 physical component summary (norm-based domain score were used in analyses; with a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity) and CRP in mg/L. PASDAS was composite score and was a weighted index with score range of 0 to 10, where higher score indicated more severe disease.	Sub-study: Baseline (Day 1), Months 1, 3, 9 and 12
Secondary	Sub-study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) at Months 1, 3, 6, 9 and 12	PsARC was comprised of 4 clinical improvement criteria: >=20% improvement in PhyGA (VAS), >=20% improvement in PtGA; and >= 30% reduction in the number of tender joints; and >=30% reduction in the number of swollen joints. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher score = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher score = more pain. To achieve a clinical response, the participant must improve in 2 of the 4 PsARC criteria, 1 of which has to be the number of tender or swollen joints and none of the 4 score could worsen.	Months 1, 3, 6, 9 and 12
Secondary	Sub-study: Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Score (For Participants With Baseline PGA-PsO Score >0 ) at Months 1, 3, 6, 9 and 12	The PGA-PsO is a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling were scored separately over the whole body according to a 5-point severity scale (0-4). Higher score indicated higher disease severity. Severity score for each erythema, induration and scaling were summed and averaged after which the total average was rounded to the nearest whole number score to determine a PGA-PsO score on a scale of 0 to 4 (0= clear, except for any residual discoloration, 1= almost clear, 2= mild, 3= moderate, 4= severe).	Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub-study: Percent Change From Baseline in Body Surface Area (BSA) (For Participants With BSA >0%) Psoriasis at Months 1, 3, 6, 9 and 12	Assessment of BSA with psoriasis was estimated by means of the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumb together) represented approximately 1% of the total BSA. Body regions are assigned specific number of handprints with percentage (Head and neck = 10 handprints [1 handprint =10%], upper extremities = 20 handprints [1 handprint =5%], Trunk (including axillae and groin) = 30 handprints [1 handprint =3.33%], lower extremities (including buttocks) = 40 handprints [1 handprint =2.5%]. The number of handprints of psoriatic skin in a body region was used to determine the extent (%) to which a body region was involved with psoriasis. The total BSA affected was the summation of individual regions affected.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub-study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12	Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis was scored on a scale of 0-3, where 0 =no tenderness and 3 =extreme tenderness in each digit of the hands and feet. The range of total dactylitis score for a participant was 0-60. Higher score indicated greater degree of tenderness.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub-study: Percentage of Participants With Absence of Dactylitis (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12	Dactylitis was characterized by swelling of the entire finger or toe. The DSS was a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis was scored on a scale of 0-3, where 0 =no tenderness and 3 =extreme tenderness in each digit of the hands and feet. The range of total dactylitis score for a participant was 0-60. Higher score indicated greater degree of tenderness.	Sub-study: Months 1, 3, 6, 9 and 12
Secondary	Sub-study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12	Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and Achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub-study: Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI =0) at Months 1, 3, 6, 9 and 12	Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and Achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis.	Sub-study: Months 1, 3, 6, 9 and 12
Secondary	Sub-study: Percentage of Participants With Absence of Enthesitis Assessed Using Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12	Enthesitis was inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assessed enthesitis in 6 sites including (right and left): lateral epicondyle humerus, medial femoral condyle and achilles tendon insertion. Tenderness is recorded as either present (score 1) or absent (score 0) for each of the 6 sites for a total score of 0-6. Higher score indicated a greater number of sites that are affected by enthesitis.	Sub-study: Months 1, 3, 6, 9 and 12
Secondary	Sub-study: Percentage of Participants With Minimal Disease Activity (MDA) at Months 1, 3, 6, 9 and 12	A psoriatic arthritis participant was considered with minimal disease activity if participant had >= 5 of 7 criteria: 1) tender/painful joint count less than or equals to (<=) 1; (2) swollen joint count <=1; (3) BSA <=3%; (4) Patient Assessment of Arthritis Pain (VAS) <=15 mm; (5) PtGA (VAS) <=20 mm; (6) HAQ-DI score <=0.5; (7) tender entheseal points (using LEI) <=1.	Sub-study: Months 1, 3, 6, 9 and 12
Secondary	Sub-study: Change From Baseline in Tender/Painful Joint Count at Months 1, 3, 6, 9 and 12	68 joints were assessed to determine joints that are considered tender or painful. Response to pressure/motion on each joint was assessed using the following scale: Present/Absent/Not Done/Done/Not Applicable (to be used for artificial or missing joints). The 68 joints assessed were: 1) Upper Body: temporomandibular, sternoclavicular, acromioclavicular. 2) Upper Extremity: shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V). 3) Lower Extremity: hip, knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub-study: Change From Baseline in Swollen Joint Count at Months 1, 3, 6, 9 and 12	Joints were assessed for swelling using the following scale: Present/Absent/Not Done/Not Applicable (to be used for artificial or missing joints). Sixty-six (66) joints were assessed for swelling. The 66 joints assessed were: 1) Upper Body: temporomandibular, sternoclavicular, acromioclavicular. 2) Upper Extremity: shoulder, elbow, wrist (includes radiocarpal, carpal and carpometacarpal considered as one unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal (IP), proximal interphalangeals (PIP II, III, IV, V), distal interphalangeals (DIP II, III, IV, V). 3) Lower Extremity: knee, ankle, tarsus (includes subtalar, transverse tarsal and tarsometatarsal considered as one unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe IP, proximal and distal interphalangeals combined (PIP II, III, IV, V).	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub-study: Change From Baseline in Physician's Global Assessment of Arthritis (PhyGA) at Months 1, 3, 6, 9 and 12	The investigator or qualified assessor assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease signs, functional capacity and physical examination, and independent of the PtGA and Patient Assessment of Arthritis Pain. The investigator's response was recorded using a 100 mm VAS where 0 =PSA not active at all and 100 =PSA extremely active. Higher score indicated more PSA.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub-study: Change From Baseline in Patient's Global Assessment of Arthritis (PtGA) at Months 1, 3, 6, 9 and 12	Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participant's response were recorded using a 0 - 100 mm VAS where 0 =not affected at all and 100 =extremely affected. Higher score indicated worse condition due to PSA.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub-study: Change From Baseline in Patient's Assessment of Arthritis Pain at Months 1, 3, 6, 9 and 12	Participants assessed the severity of their arthritis pain using a 100 mm VAS by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain. Higher score indicated more severe pain.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub-study: Change From Baseline in C-Reactive Protein (CRP) at Months 1, 3, 6, 9 and 12	The test for CRP was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Component Summary Score at Months 1, 3, 6, 9 and 12	The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a standard deviation (SD) of 10 points, and ranges from minus infinity to plus infinity. A higher PCS score represents better physical health status.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Component Summary Score at Months 1, 3, 6, 9 and 12	The SF-36v2 acute is a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. An additional item measures health transition. The 8 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Norm-based domain scores, PCS and MCS scores are used in the analyses; each of which has a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher MCS score represents better mental health status.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Physical Functioning Domain Score at Months 1, 3, 6, 9 and 12	SF-36v2 was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 10 items of the physical functioning scale represented levels and kinds of limitations between extremes of physical activities, including lifting & carrying groceries; climbing stairs; bending, kneeling, or stooping; walking moderate distances; self-care limitations. The physical functioning items capture the presence & extent of physical limitations using a 3-level response continuum. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher physical functioning domain score represented better physical functioning.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role Physical Domain Score at Months 1, 3, 6, 9 and 12	SF-36v2 acute was a 36-item measure evaluating 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, & mental health. The 4-item role-physical scale covers an array of physical health-related role limitations, including: a) limitations in the kind of work or other usual activities; b) reductions in the amount of time spent on work or other usual activities; c) difficulty performing work or other usual activities; & d) accomplishing less. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher role-physical domain score represented better role-physical functioning.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Bodily Pain Domain Score at Months 1, 3, 6, 9 and 12	The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity. A higher bodily pain domain score represented less bodily pain.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) General Health Domain Score at Months 1, 3, 6, 9 and 12	The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The general health scale consisted of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher general health domain score represented better general health perceptions.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Vitality Domain Score at Months 1, 3, 6, 9 and 12	The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 4-item measure of vitality captures a broad range of subjective evaluations of well-being from feelings of tiredness and being worn out to feeling full of energy all or most of the time. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher vitality domain score represented better vitality.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Social Functioning Domain Score at Months 1, 3, 6, 9 and 12	The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 2-item social functioning scale assessed health-related effects on quantity and quality of social activities. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher social functioning domain score represented better social functioning.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub-study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Role Emotional Domain Score at Months 1, 3, 6, 9 and 12	The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 3-item role-emotional scale assessed mental health-related role limitations in terms of a) time spent in work or other usual activities; b) amount of work or activities accomplished; c) care with which work or other activities were performed. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher role-emotional domain score represented better role-emotional functioning.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub Study: Change From Baseline in Short-Form-36 Health Survey Version 2 (SF-36v2) Mental Health Domain Score at Months 1, 3, 6, 9 and 12	The SF-36v2 acute was a 36-item measure that evaluates 8 domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The 5-item mental health scale includes 1 or more items from each of 4 major mental health dimensions: anxiety, depression, loss of behavioral/emotional control, and psychological well-being. Norm-based domain scores were used in the analyses; each of which had a population mean of 50 with a SD of 10 points, and ranged from minus infinity to plus infinity. A higher mental health domain score represented better mental health functioning.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Months 1, 3, 6, 9 and 12	FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52):calculated by summing 13 items,higher score indicated lower level of fatigue, better participant status. All responses were added with equal weight to get total score.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Experience Domain Score at Months 1, 3, 6, 9 and 12	FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue, better participant status):calculated by summing 13 items, all responses were added with equal weight to get total score.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub Study: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Impact Domain Score at Months 1, 3, 6, 9 and 12	FACIT-F:13-item questionnaire answered by participants,with each item scaled from 0(not at all) to 4(very much). 3 endpoints were derived:1)change in FACIT-F experience domain(score 0-20, higher score indicate less fatigue experience),calculated by summing 5 items(felt fatigued,felt weak all over,felt listless ["washed out"],felt tired,had energy; 2)change in FACIT-F impact domain(score 0-32,higher score indicate less fatigue impact on daily functioning),calculated by summing remaining 8 items(had trouble starting things as tired,had trouble finishing things as tired,was able to do usual activities,needed to sleep during day,too tired to eat,needed help doing my usual activities,frustrated by being too tired to do things wanted to do,had to limit my social activity because tired); 3)change in FACIT-F total score(0-52,higher score indicated lower level of fatigue, better participant status):calculated by summing 13 items, all responses were added with equal weight to get total score.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Mobility Domain at Months 1, 3, 6, 9 and 12	EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L mobility domain score were reported in this measure.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Self-Care Domain at Months 1, 3, 6, 9 and 12	EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L self-care domain score were reported in this measure.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Usual Activities Domain at Months 1, 3, 6, 9 and 12	EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L usual activities domain score were reported in this measure.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain	EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L pain/discomfort domain score were reported in this measure.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Anxiety/Depression Domain at Months 1, 3, 6, 9 and 12	EQ-5D-3L, a health profile questionnaire was used to assess quality of life along 5 dimensions i.e. mobility, self-care, usual activities, pain/discomfort and anxiety/depression) are assessed. The status of each dimension had 3 possible responses (1 =no problem, 2= some problem 3 =severe problems) in the relevant health dimension. Higher score indicated a worsening health condition. Data for change from baseline in EQ-5D-3L anxiety/depression domain score were reported in this measure.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Secondary	Sub Study: Change From Baseline in EuroQol - Visual Analog Scale (EQ-VAS) Your Own Health State Today Domain at Months 1, 3, 6, 9 and 12	The EQ VAS recorded the participant's self-rated health on a vertical VAS as standard verticle 0 (worst imaginable health state) to 100 mm (best imaginable health state) (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state; higher score indicated a better health state.	Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12

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