Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors

Psoriatic Arthritis Clinical Trial

— OPAL BEYOND  

Official title:

A Phase 3, Randomized, Double-blind, Placebo-controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (Cp-690,550) In Subjects With Active Psoriatic Arthritis And An Inadequate Response To At Least One Tnf Inhibitor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01882439
• Other study ID #: A3921125
• Secondary ID: 2013-001368-46
• Status: Completed
• Phase: Phase 3
• First received: June 18, 2013
• Last updated: September 8, 2017
• Start date: August 2013
• Est. completion date: April 2016

Study information

• Verified date: September 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To examine the safety and efficacy of tofacitinib in subjects with active psoriatic arthritis who have previously had an inadequate response to at least one TNF inhibitor either due to lack of efficacy or an adverse event.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 395
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints

• Active plaque psoriasis at screening

• Inadequate efficacy or lack of toleration to previously administered TNF inhibitor

Exclusion Criteria:

• Non-plaque forms of psoriasis (with exception of nail psoriasis)

• History of autoimmune rheumatic disease other than PsA; also prior history of or current, rheumatic inflammatory disease other than PsA

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• Tofacitinib
tablets, 5 mg BID x 6 months
• Tofacitinib
tablets, 10 mg BID x 6 months

Other:
• Placebo
tablets, to match tofacitinib 5 mg BID x 3 months

Drug:
• Tofacitinib
tablets, 5 mg BID x 3 months

Other:
• Placebo
tablets, to match tofacitinib 10 mg BID x 3 months

Drug:
• Tofacitinib
tablets, 10 mg BID x 3 months

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital, Rheumatology Department	Camperdown	New South Wales
Australia	Emeritus Research Pty Ltd	Malvern East	Victoria
Australia	Rheumatology Research Unit	Maroochydore	Queensland
Belgium	Hospital Erasme - Clinique Universitaire de Bruxelles	Brussels
Belgium	ReumaClinic	Genk
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	University Hospital Leuven, Department of Rheumatology	Leuven
Belgium	ZNA Jan Palfijn	Merksem
Brazil	Clinica Medica Bonfiglioli Ltda. / Clinica Bonfiglioli	Campinas	SP
Brazil	Radiologia Clínica de Campinas - RCC (Images only)	Campinas	São Paulo
Brazil	CETAC - DIAGNOSTICO POR IMAGEM (image only)	Curitiba	PR
Brazil	EDUMED - Educacao em Saude SS LTDA.	Curitiba	PR
Brazil	CMIP: Centro Mineiro de Pesquisa Ltda /	Juiz de Fora	MG
Brazil	Hospital de Clinicas de Porto Alegre (HCPA) / UFRGS	Porto Alegre	RS
Czechia	Medical Plus s.r.o.	Uherske Hradiste
France	Hopital Avicenne	Bobigny
France	Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie	Corbeil-Essonnes	Cedex
Germany	Rheumazentrum Prof. Dr. med Gunther Neeck	Bad Doberan
Germany	Charite Universitatsmedizin Berlin - Campus Charite Mitte	Berlin
Germany	Rheumapraxis Steglitz	Berlin
Germany	Schlosspark-Klinik	Berlin
Germany	Universitaetsklinikum Erlangen, Medizinische Klinik 3	Erlangen
Germany	CIRI - Centrum für innovative Diagnostik und Therapie Rheumatologie/Immunologie (GmbH)	Frankfurt am Main
Germany	Medizinische Universitatsklinik 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
Mexico	Christus Muguerza del parque, S.A de C.V	Chihuahua
Mexico	Investigacion y Biomedicina de Chihuahua	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 (For Emergencies Only)	Culiacan	Sinaloa
Mexico	Centro Integral en Reumatologia SA de CV	Guadalajara	Jalisco
Mexico	Grupo Santa Bernardette S.A. de C.V.	Guadalajara	Jalisco
Mexico	Star Medica S.A. de C.V. (For Emergencies Only)	Merdia	Yucatan
Mexico	Centro de Investigacion Clinica Pensiones	Merida	Yucatan
Mexico	Centro Multidisciplinario para el Desarrollo	Merida	Yucatan
Mexico	Hospital Star Medica Merida (For Emergencies Only)	Merida	Yucatan
Mexico	Institute Medico Panamericano, S.A. de C.V. (For Emergencies Only)	Merida	Yucatan
Mexico	Unidad Reumatologica Las Americas SCP	Merida	Yucatan
Mexico	CLIDITER, S.A. de C.V.	Mexico	Distrito Federal
Mexico	Medica Sur, S.A.B. de C.V. (For Emergencies Only)	Mexico	Distrito Federal
Mexico	Universidad La Salle AC	Mexico	Distrito Federal
Mexico	Grupo Medico Camino S.C.	Mexico City	Distrito Federal
Mexico	Hospital Angeles Clinica Londres	Mexico City	D.F
Poland	Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzez	Elblag
Poland	Centrum Radiologii for X-Ray only	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 Spozielni Pracy "Medica" for X-Ray Only	Grodzisk Mazowiecki
Poland	Specjalistyczne Gabinety Lekarskie "DERMED" Anna Kaszuba	Lodz
Poland	NZOZ Lecznica MAK-MED S.C.	Nadarzyn
Poland	Prywatna Praktyka Lekarska Prof. UM dr hab. Pawel Hrycaj	Poznan
Poland	Reumatika Centrum Reumatologii nzoz	Warszawa
Russian Federation	State Autonomic Healthcare Institution City Clinical Hospital # 7	Kazan	Republic of Tatarstan, Russia
Russian Federation	SBIH of Moscow "City Clinical Hospital#1 n. a. N.I. Pirogov" of the Healthcare Department of Moscow	Moscow
Russian Federation	City Neurological Centre "SibNeyroMed", LLC	Novosibirsk
Russian Federation	Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"	Novosibirsk
Russian Federation	Regional State Budgetary Healthcare Institution of Karelia Republic "Republic Hospital n.a.	Petrozavodsk	Karelia Republic
Russian Federation	State Budget Educational Institution of Highest Professional Education	Tomsk
Russian Federation	State Institution of Healthcare of Yaroslavl Region	Yaroslavl
Slovakia	MEDMAN s.r.o. - reumatologicka ambulancia	Martin
Spain	Complejo 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 Universitario Virgen Macarena	Sevilla
Spain	Hospital Sierrallana	Torrelavega	Cantabria
Spain	Hospital Universitaro Y Politecnico La Fe	Valencia
Taiwan	Buddhist Dalin Tzu Chi General Hospital	Chia-Yi
Taiwan	Chang Gung Medical Foundation-Kaohsiung Branch	Kaohsiung City
Taiwan	China Medical University Hospital	Taichung
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	Taipei Veterans General Hospital	Taipei	Taiwan Roc
United Kingdom	Royal United Hospitals NHS Foundation Trust	Bath
United Kingdom	Bradford Royal Infirmary, BTHFT	Bradford	West Yorkeshire
United Kingdom	Bradford Teaching Hospitals NHS Foundation Trust	Bradford
United Kingdom	The Dudley Group NHS Foundation Trust	Dudley	West Midlands
United Kingdom	Barking Havering and Redbridge University Hospitals NHS Trust	Goodmayes	Essex
United Kingdom	Barking, Havering and Redbridge University Hospitals NHS Trust	Romford	Essex
United Kingdom	York Hospital, York Teaching Hospital NHS Foundation Trust	York
United States	East Penn Rheumatology Associates, PC	Bethlehem	Pennsylvania
United States	Rheumatology Associates P.C.	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	Brigham and Women's Hospital	Boston	Massachusetts
United States	Low Country Rheumatology, PA	Charleston	South Carolina
United States	Cincinnati Rheumatic Disease Study Group, Inc.	Cincinnati	Ohio
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Adriana M. Pop-Moody, M.D., Clinic, P.A.	Corpus Christi	Texas
United States	Medvin Clinical Research	Covina	California
United States	Pioneer Research Solutions, Inc.	Cypress	Texas
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	St. Paul Rheumatology, PA	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 & 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 (DHMC)	Lebanon	New Hampshire
United States	Bluegrass Community Research, Inc	Lexington	Kentucky
United States	Physician Research Collaboration, LLC	Lincoln	Nebraska
United States	Ronald Reagan UCLA Medical Center, Drug Information Center	Los Angeles	California
United States	UCLA David Geffen School of Medicine	Los Angeles	California
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	Arthritis Center, Inc.	Palm Harbor	Florida
United States	Integral Rheumatology & Immunology Specialists (IRIS)	Plantation	Florida
United States	Clayton Medical Research	Saint Louis	Missouri
United States	Drug Shipment/Storage: Investigational Drug Services	Salt Lake City	Utah
United States	University of Utah Hospital & Clinics	Salt Lake City	Utah
United States	San Diego Arthritis Medical Clinic	San Diego	California
United States	Dynacare Laboratories	Seattle	Washington
United States	Seattle Rheumatology Associates	Seattle	Washington
United States	Swedish Medical Center	Seattle	Washington
United States	Stanford Hospital and Clinics	Stanford	California
United States	New England Research Associates, LLC	Trumbull	Connecticut
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,  Czechia,  France,  Germany,  Mexico,  Poland,  Russian Federation,  Slovakia,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (=) 20% (ACR20): Month 3	ACR20 was calculated as a =20% improvement from baseline in tender/painful and swollen joint counts and =20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, Health Assessment Questionnaire - Disability Index (HAQ-DI), and C-reactive protein (CRP).	Month 3
Primary	Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Month 3	The HAQ-DI assesses the difficulty a patient has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability. Overall score was computed as the sum of the domain scores divided by the number of domains answered. The total possible score ranged from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability.	Month 3
Secondary	Percentage of Participants Meeting American College of Rheumatology Response Criteria =50% (ACR50) at Week 2 and Months 1, 2, 3, 4, and 6	ACR50 was calculated as a =50% improvement from baseline in tender /painful and swollen joint counts and =50% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. n=number of responders.	Week 2 and Months 1, 2, 3, 4, and 6
Secondary	Percentage of Participants Meeting American College of Rheumatology Response Criteria =70% (ACR70) at Week 2 and Months 1, 2, 3, 4, and 6	ACR70 was calculated as a =70% improvement from baseline in tender /painful and swollen joint counts and =70% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. n=number of responders.	Week 2 and Months 1, 2, 3, 4, and 6
Secondary	Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (=) 20% (ACR20): Week 2 and Months 1, 2, 4, and 6	ACR20 was calculated as a =20% improvement from baseline in tender /painful and swollen joint counts and =20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, HAQ-DI, and CRP. n=number of responders.	Week 2 and Months 1, 2, 4, and 6
Secondary	Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Week 2 and Months 1, 2, 4, and 6	The HAQ-DI assesses the difficulty a patient has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability. Overall score was computed as the sum of the domain scores divided by the number of domains answered. The total possible score ranged from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability. n=number of participants evaluable at each visit.	Week 2 and Months 1, 2, 4, and 6
Secondary	Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components: C-reactive Protein (CRP) Levels: Month 3	The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.	Month 3
Secondary	Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Assessment of Arthritis Pain: Month 3	Participants assessed the severity of their arthritis pain using a 100 mm visual analog scale (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.	Month 3
Secondary	Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Patient's Global Assessment of Arthritis: Month 3	Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participant's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very well) and 100 (very poorly).	Month 3
Secondary	Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Physician's Global Assessment of Arthritis: Month 3	The blinded 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 was independent of the Patient's Global Assessment of Arthritis. The investigator's response was recorded using a 100 mm VAS by placing a mark on the scale between 0 (very good) and 100 (very poor).	Month 3
Secondary	Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Swollen Joint Count: Month 3	Swollen joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty six (66) joints were assessed by a blinded assessor to determine the number of joints that were considered swelling.	Month 3
Secondary	Change From Baseline in American College of Rheumatology (ACR) Response Criteria Components Score: Tender/Painful Joint Count: Month 3	Tender/painful joint counts are considered the most specific quantitative clinical measure used to assess the status of participants with inflammatory types of arthritis. Sixty eight (68) joints were assessed by a blinded assessor to determine the number of joints that were considered tender or painful.	Month 3
Secondary	Percentage of Participants Meeting Psoriatic Arthritis Response Criteria (PsARC): Week 2, Months 1, 2, 3, 4, and 6	The PsARC covers 4 measures: Tender joint count, swollen joint count, the Physician's Global Assessment of Arthritis, and the Patient's Global Assessment of Arthritis. The PsARC response is defined as improvement in 2 of 4 items, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement criteria: =20% improvement in Physician's Global Assessment of Arthritis; =20% improvement in Patient's Global Assessment of Arthritis; =30% improvement in tender joint count; and =30% improvement in swollen joint count. n=number of responders.	Week 2, Months 1, 2, 3, 4, and 6
Secondary	Change From Baseline in Physician's Global Assessment of Psoriasis (PGA-PsO) Response: Months 1, 3, and 6	The PGA-PsO is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are rated separately over the whole body according to a 5-point severity scale, scored as 0=none; 1, 2, 3, or 4=most severe. The severity rating scores are summed and the average taken; the total average is rounded to the nearest whole number score to determine the PGA-PsO score on a scale of 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe). n=number of participants evaluable at each visit.	Months 1, 3, and 6
Secondary	Percentage of Participants With Psoriasis Area and Severity Index 75 (PASI75) Response: Months 1, 3, and 6	PASI determines psoriasis severity based on lesion severity and percentage of body surface area (BSA) affected. Lesion severity is assessed for erythema, induration, and scaling evaluated separately for the head and neck, upper limbs, trunk, and lower limbs and then rated for each body area according to a 5 point scale: 0=no involvement; 1=slight; 2=moderate; 3=marked; 4=very marked. BSA involvement is the extent (%) of body area affected by psoriasis and is assigned a numerical score: 0=no involvement; 1=0% to 9%; 2=10% to 29%; 3=30% to 49%; 4=50% to 69%; 5=70% to 89%; 6=90% to 100%. In each area, the sum of the severity rating scores is multiplied by the score representing the percentage of this area involved by psoriasis, multiplied by a weighting factor (head 0.1; upper limbs 0.2; trunk 0.3; lower limbs 0.4). The sum of the numbers obtained for each of the 4 body areas is the PASI. PASI75 is defined as a 75% reduction from baseline in PASI. n=number of responders.	Months 1, 3, and 6
Secondary	Change From Baseline in Dactylitis Severity Score (DSS): Months 1, 3, and 6	Dactylitis is characterized by swelling of the entire finger or toe. The DSS is a function of finger circumference and tenderness, assessed and summed across all dactylitic digits. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness. n=number of participants evaluable at each visit.	Months 1, 3, and 6
Secondary	Change From Baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Months 1, 3, and 6	The SPARCC Enthesitis Index identifies the presence or absence of tenderness at 16 enthesial sites, including the bilateral Achilles tendons, plantar fascia insertion at the calcaneus, patellar tendon insertion at the base of the patella, quadriceps insertion into the superior border of the patella, supraspinatus insertion into the greater tuberosity of the humerus, and medial and lateral epicondyles. On examination, tenderness is 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 indicates a greater number of sites that are affected by enthesitis. n=number of participants evaluable at each visit.	Months 1, 3, and 6
Secondary	Change From Baseline in the Leeds Enthesitis Index (LEI): Months 1, 3, and 6	Enthesitis is inflammation in the tendon, ligament, and joint capsule fiber insertion into bone. The LEI assesses enthesitis in 6 sites. Tenderness is recorded as either present (1) or absent (0) for each of the 6 sites, for a total score of 0-6. Higher score indicates greater severity of enthesitis. n=number of participants evaluable at each visit.	Months 1, 3, and 6
Secondary	Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Physical Component Summary Score: Months 1, 3, 6	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 health domains are aggregated into two summary scores known as the physical component summary (PCS) score and the mental component summary (MCS) score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the United States (US) 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher PCS score represents better physical health status. n=number of participants evaluable at each visit.	Months 1, 3, 6
Secondary	Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Mental Component Summary Score: Months 1, 3, 6	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 health domains are aggregated into two summary scores known as the PCS score and the MCS score. Normalized domain scores, PCS and MCS scores are used in the analyses. The component and domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 and SF36 health domain scales and component summary measures have means of 50 and standard deviations of 10. A higher MCS score represents better mental health status. n=number of participants evaluable at each visit.	Months 1, 3, 6
Secondary	Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Physical Functioning Domain: Months 1, 3, 6	SF-36v2 acute is 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 represent levels & 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. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher physical functioning domain score represents better physical functioning. n=number of participants evaluable at each visit.	Months 1, 3, 6
Secondary	Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Role-physical Domain: Months 1, 3, 6	SF-36v2 acute is 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. Items in the role-physical scale are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher role-physical domain score represents better role-physical functioning. n=number of participants evaluable at each visit.	Months 1, 3, 6
Secondary	Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Bodily Pain Domain: Months 1, 3, 6	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 bodily pain scale comprises of 2 items pertaining to the intensity of bodily pain and extent of interference with normal work activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher bodily pain domain score represents less bodily pain. n=number of participants evaluable at each visit.	Months 1, 3, 6
Secondary	Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): General Health Domain: Months 1, 3, 6	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 general health scale consists of 5 items including a rating of health and 4 items addressing the respondent's view and expectations of his or her health. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher general health domain score represents better general health perceptions. n=number of participants evaluable at each visit.	Months 1, 3, 6
Secondary	Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Vitality Domain: Months 1, 3, 6	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. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher vitality domain score represents better vitality. n=number of participants evaluable at each visit.	Months 1, 3, 6
Secondary	Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Social Functioning Domain: Months 1, 3, 6	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 2-item social functioning scale assesses health-related effects on quantity and quality of social activities. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher social functioning domain score represents better social functioning. n=number of participants evaluable at each visit.	Months 1, 3, 6
Secondary	Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Role-emotional Domain: Months 1, 3, 6	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 3-item role-emotional scale assesses 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. All 3 items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher role-emotional domain score represents better role-emotional functioning. n=number of participants evaluable at each visit.	Months 1, 3, 6
Secondary	Change From Baseline in the Short-Form-36 Health Survey Version 2, Acute Components (SF-36v2 Acute): Mental Health Domain: Months 1, 3, 6	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 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. All items are answered on a 5-point scale. The domain scores were scored using the US 1998 general population norms. The resulting norm-based T-scores for both the SF36 version 2 & SF36 health domain scales & component summary measures have means of 50 & standard deviations of 10. A higher mental health domain score represents better mental health functioning. n=number of participants evaluable at each visit.	Months 1, 3, 6
Secondary	Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Mobility: Months 1, 3, 6	The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.	Months 1, 3, 6
Secondary	Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Self-Care: Months 1, 3, 6	The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.	Months 1, 3, 6
Secondary	Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Usual Activities: Months 1, 3, 6	The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.	Months 1, 3, 6
Secondary	Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Pain/Discomfort: Months 1, 3, 6	The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.	Months 1, 3, 6
Secondary	Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on a Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Anxiety/Depression: Months 1, 3, 6	The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.	Months 1, 3, 6
Secondary	Change From Baseline in Score on EuroQol-5 Dimension Health State Profile (EQ-5D) and Change in Patient's Self-rated Health on Vertical Visual Analogue Scale (VAS) Recorded on the EQ-5D Questionnaire (EQ-VAS): Patient's Health State Today: Months 1, 3, 6	The EQ-5D is a descriptive system of health-related quality of life states consisting of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) each of which can take 1 of 3 responses. The responses record 3 levels of severity (no problems/some or moderate problems/extreme problems) within a particular EQ-5D dimension. Standard vertical 0 to 100 mm VAS (similar to a thermometer) for recording an individual's rating for their current health-related quality of life state, with a higher value representing better health status. n=number of participants evaluable at each visit.	Months 1, 3, 6
Secondary	Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Total Score: Months 1, 3, 6	FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better fatigue status. n=number of participants evaluable at each visit.	Months 1, 3, 6
Secondary	Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Experience Domain Score: Months 1, 3, 6	FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue experience. n=number of participants evaluable at each visit.	Months 1, 3, 6
Secondary	Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores: Impact Domain Score: Months 1, 3, 6	FACIT-F is a 13-item questionnaire, with each item score ranging from 0 to 4. Three endpoints are derived: change in FACIT-F total score, change in FACIT-F experience domain score, and change in FACIT-F impact domain score. FACIT-F total score (range 0-52) is calculated by summing the 13 items. FACIT-F experience domain score (range 0-20) is calculated by summing 5 items : I feel fatigued, I feel weak all over, I feel listless ("washed out"), I feel tired, and I have energy, while FACIT-F impact domain score (range 0-32) is calculated by summing the remaining 8 items. All responses are added with equal weight to obtain the total score. Higher scores represent better (less) fatigue impact on daily functioning. n=number of participants evaluable at each visit.	Months 1, 3, 6
Secondary	Change From Baseline in Score Evaluating Spondylitis Using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Months 1, 3, 6	BASDAI is a validated self-assessment tool used to determine disease activity in participants with ankylosing spondylitis. Utilizing a VAS of 0-10 (0=none and 10=very severe) participants answered 6 questions measuring discomfort, pain, and fatigue. The final BASDAI score averaged the individual assessments for a final score ranging 0-10cm, with higher scores representing more severe ankylosing spondylitis disease activity. n=number of participants evaluable at each visit.	Months 1, 3, 6

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