Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study

Psoriatic Arthritis Clinical Trial

— OPAL BROADEN  

Official title:

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (CP-690,550) Or Adalimumab In Subjects With Active Psoriatic Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877668
• Other study ID #: A3921091
• Secondary ID: 2011-003668-55
• Status: Completed
• Phase: Phase 3
• First received: June 12, 2013
• Last updated: April 13, 2016
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a 12 month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms, improving physical function and preserving bone structure in patients with active psoriatic arthritis and had inadequate response to a traditional, non-biologic disease modifying anti-rheumatic drug. Adalimumab is use as a comparator.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 422
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males or females, aged >= 18 years at time of consent.

• Have a diagnosis of Psoriatic arthritis (PsA) of >= 6 months

• Meet the Classification Criteria of PsA (CASPAR) at time of screening

• Must not have been adequately treated with a a traditional non-biologic disease modifying anti-rheumatic drug (DMARD).

• Concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and required

• Must not have taken a biologic Tumour Necrosis Factor Inhibitor

• Must have 3 or more swollen joints AND 3 or more tender joints

• Must have active psoriasis skin lesions

Exclusion Criteria:

• Have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the exception of nail psoriasis which is allowed

• Pregnant or breast feeding, females of child-bearing potential not using highly effective contraception

• New York Heart Association Class III and IV congestive heart failure

• History of hypersensitivity or infusion reaction to biologic agents

• Infection with HIV, hepatitis B virus, hepatitis C virus, or other chronic infection

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• Tofacitinib 5 mg BID
Tofacitinib orally (po) 1 tablet of 5 mg and placebo po 1 tablet BID x 12 months Placebo injections subcu every 2 weeks x 12 months
• Tofacitinib 10 mg BID
Tofacitinib po 2 tablets of 5 mg BID x 12 months Placebo injections subcu every 2 weeks x 12 months
• Adalimumab
Placebo po 2 tablets BIDx 12 months Adalimumab 40 mg subcu injections every 2 weeks x 12 months
• Placebo
Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 1 tablet of 5 mg and placebo po 1 tablet BID x 9 months Placebo injections every 2 weeks x 12 months
• Placebo
Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 2 tablets (5 mg) BID x 9 months Placebo injections every 2 weeks x 12 months

Locations

Country	Name	City	State
Australia	Monash Health, Monash Medical Centre	Clayton	Victoria
Australia	Pharmacy Clinical Trials	Clayton	Victoria
Australia	St. Vincent's Hospital (Melbourne)	Fitzroy	Victoria
Australia	Rheumatology Research Unit	Maroochydore	Queensland
Australia	Emeritus Research Pty Ltd	Melbourne	Victoria
Australia	Pacific Private Clinic	Southport	Queensland
Belgium	Hopital Erasme	Brussels
Belgium	Hopital Erasme - Clinique Universitaire de Bruxelles	Brussels
Belgium	Hôpital Erasme - Service Pharmacie - Essais Cliniques	Brussels
Belgium	University Hospital Leuven, Department of Rheumatology	Leuven
Bulgaria	UMHAT "Dr. G. Stranski" EAD	Pleven
Bulgaria	MHAT "Kaspela" EOOD	Plovdiv
Bulgaria	MHAT"Plovdiv" AD	Plovdiv
Bulgaria	UMHAT "Sv. Ivan Rilski" EAD	Sofia
Bulgaria	Medical Center - "New rehabilitation center" EOOD	Stara Zagora
Canada	Rheumatology Research Associates	Edmonton	Alberta
Canada	West Island Rheumatology Research Associates	Pointe-Claire	Quebec
Canada	K. Papp Clinical Research	Waterloo	Ontario
Czech Republic	Lekarna Na Lidicke (Pharmacy only)	Brno
Czech Republic	Revmacentrum, MUDr. Mostera s.r.o.	Brno
Czech Republic	Revmatologie s.r.o.	Brno
Czech Republic	Stavovska s.r.o. (pharmacy only)	Brno
Czech Republic	X-MEDICA s.r.o (radiology only)	Brno
Czech Republic	Vesalion s.r.o.	Ostrava
Czech Republic	MEDIGAP, s.r.o. (radiology only)	Praha 1 - Nove Mesto
Czech Republic	MEDIGAP, s.r.o	Praha 1- Nove Mesto
Czech Republic	Revmatologicky ustav	Praha 2
Czech Republic	Revmatologicky ustav - Lekarna	Praha 2
Czech Republic	Revmatologicky Ustav - Lekarna (pharmacy only)	Praha 2
Czech Republic	Revmatologicka ambulance	Praha 4
Czech Republic	Medical Plus s.r.o. Lekarna Hradebni s. r.o	Uherske Hradiste
France	Centre Hospitalier Sud-Francilien - Secretariat de Rhumatologie	Corbeil Essonnes cedex
Germany	Charite Universitaetsmedizin Berlin	Berlin
Germany	Klinische Forschung Berlin-Mitte GmbH	Berlin
Germany	Rheumapraxis Steglitz	Berlin
Germany	University Hospital of Cologne	Koeln
Germany	Klinische Forschung Schwerin GmbH	Schwerin
Hungary	Magyar Honvedseg Egeszsegugyi Kozpont,Reumatologiai osztaly	Budapest
Hungary	Qualiclinic Kft.	Budapest
Hungary	Revita Reumatologiai Rendelo	Budapest
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 Culiacán Dr. Bernardo J. Gastélum	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	Centro de Investigacion Clinica Pensiones	Merida	Yucatan
Mexico	Centro Multidisciplinario para el Desarrollo Especializado	Merida	Yucatan
Mexico	Hospital Star Medica Merida (For Emergencies Only)	Merida	Yucatan
Mexico	HOSPITAL STAR MEDICA S.A DE C.V- (emergencies only)	Merida	Yucatan
Mexico	Instituto Medico Panamericano, S.A. de C.V. (For Emergencies Only)	Merida	Yucatan
Mexico	Unidad Reumatologica Las Americas, S.C.P.	Merida	Yucatan
Mexico	Cliditer, S. A. de C. V	Mexico City
Poland	ClinicMed Badurski i wspolnicy Spolka Jawna	Bialystok
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Chirurgiczna dla Dzieci "PriamaMed" Sp.P.,"	Bialystok
Poland	NZOZ Osteo-Medic s.c. A. Racewicz, 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 for X-Ray only	Elblag
Poland	NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela	Elblag
Poland	Przychodnia Specjalistyczna Lekarskiej Spoldzielni Pracy "Medica"	Grodzisk Mazowiecki
Poland	Zespol Poradni Specjalistycznych Reumed Filia Onyksowa	Lublin
Poland	NZOZ Lecznica MAK-MED S.C.	Nadarzyn
Poland	Prywatna Praktyka Lekarska Prof. UM dr hab. Pawel Hrycaj	Poznan
Poland	NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu	Torun
Poland	Medica Pro Familia Sp. z o.o. S.K.A.	Warsaw
Poland	Klinika Ambroziak Estederm Sp. z o.o. ,S.K.A	Warszawa
Poland	Reumatika Centrum Reumatologii NZOZ	Warszawa
Poland	Rheuma Medicus Zaklad Opieki Zdrowotnej	Warszawa
Poland	Synexus Polska Sp. z o.o. Oddz. we Wroclawiu	Wroclaw
Russian Federation	State Budgetary Institution of Healthcare of Moscow City Clinical Hospital	Moscow
Russian Federation	Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"	Novosibirsk
Russian Federation	OOO City Neurological Centre Sibneiromed	Novosibirsk	Russia
Russian Federation	Regional State Budgetary Healthcare Institution of Karelia Republic	Petrozavodsk	Karelia Republic
Russian Federation	State Healthcare Institution "Regional Clinical Hospital"	Saratov
Russian Federation	State Budget Educational Institution of Highest Professional Education	Tomsk
Russian Federation	State Healthcare Institution of Yaroslavl Region Clinical Emergency Hospital n.a. N.V. Solovyev	Yaroslavl
Russian Federation	State Institution of Healthcare of Yaroslavl Region	Yaroslavl	Russia
Slovakia	Nestatna reumatologicka ambulancia	Bratislava
Slovakia	ROMJAN s.r.o., Reumatologicka ambulancia	Bratislava	Slovak Republic
Slovakia	MEDMAN s.r.o.	Martin	Slovak Republic
Slovakia	Reumex s.r.o	Rimavska Sobota
Spain	Complexo Hospitalario Universitario A Coruna	A Coruna
Spain	Corporació 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 Infanta Luisa	Sevilla
Spain	Servicio de Reumatologia Avanzada	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
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	Taipei Veterans General Hospital	Taipei	Taiwan ROC
United Kingdom	Bradford Royal Infirmary, 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	Rheumatology Associates, PC	Birmingham	Alabama
United States	Low Country Rheumatology, PA	Charleston	South Carolina
United States	Medvin Clinical Research	Covina	California
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	St. Paul Rheumatology, PA	Eagan	Minnesota
United States	Arizona Arthritis & Rheumatology Associates, P.C.	Glendale	Arizona
United States	Klein & Associates, M.D., P.A.	Hagerstown	Maryland
United States	Pioneer Research Solutions, Inc.	Houston	Texas
United States	Rheumatology Associates of North Alabama, PC	Huntsville	Alabama
United States	Dartmouth-Hitchcock Medical Center (DHMC)	Lebanon	New Hampshire
United States	Physician Research Collaboration, LLC	Lincoln	Nebraska
United States	Paramount Medical Research & Consulting, LLC	Middleburg Heights	Ohio
United States	Millennium Research	Ormond Beach	Florida
United States	Desert Medical Advances	Palm Desert	California
United States	Arthritis Center, Inc.	Palm Harbor	Florida
United States	Advances In Medicine (X-Rays)	Rancho Mirage	California
United States	Drug Shipment/Storage: Huntsman Cancer Hospital at the University of Utah	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 (Specimen processing for shipment)	Seattle	Washington
United States	Investigational Drug Service Pharmacy, Swedish Medical Center.	Seattle	Washington
United States	Seattle Rheumatology Associates	Seattle	Washington
United States	Swedish Medical Center	Seattle	Washington
United States	Clinical Pharmacology Study Group	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Bulgaria,  Canada,  Czech Republic,  France,  Germany,  Hungary,  Mexico,  Poland,  Russian Federation,  Slovakia,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With an American College of Rheumatology 20% (ACR20) Response	ACR20 response: greater than or equal to (=) 20 percent (%) improvement in tender joint count; = 20% improvement in swollen joint count; and = 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).	Month 3	No
Primary	Score on Health Assessment Questionaire-Disability Index	Score on Health Assessment Questionaire-Disability Index patient reported outcome	Month 3	No
Secondary	Change from baseline Modified Total Sharp Score (mTSS) at Month 12	mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change = scores at observation minus score at Baseline. An increase in mTSS from baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.	12 months	No
Secondary	Number of Participants With an American College of Rheumatology 20% (ACR20) Response	ACR20 response: greater than or equal to (=) 20 percent (%) improvement in tender joint count; = 20% improvement in swollen joint count; and = 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).	Week 2, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12	No
Secondary	Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response	ACR50 response: greater than or equal to (=) 50 percent (%) improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.	Week2, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12	No
Secondary	Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response	ACR70 response: greater than or equal to (=) 70 percent (%) improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.	Week 2. Month 1, Month 2, Month 4, Month 6, Month 9, Month 12	No
Secondary	ACR response criteria components	HAQ-DI, CRP, Patient's Assessment of Arthritis Pain,	Month 3	No
Secondary	Number of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)	PsARC is comprised of 4 clinical improvement criteria: 1 unit (0-5 Likert scale) improvement on the Physician Global Assessment (PGA); 20% (0-100 scale) improvement on the participant assessments; and 30% reduction in the number of tender joints; and 30% reduction in the number of swollen joints. 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 scores could worsen.	Month 1, Month 3, Month 6, Month 9, Month 12	No
Secondary	Physician Global Assessment (PGA) of Psoriasis Score	PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). 'Clear' and "Almost clear' includes all participants who were scored as a 0 or 1.	Month 1, Month 3, Month 6, MOnth 9, Month 12	No
Secondary	Psoriasis Area and Severity Index (PASI)	PASI score ranges from 0 to 72, with higher scores representing greater severity of psoriasis	Month 1, Month 3, Month 6, Month 9, Month 12	No
Secondary	Dactylitis Severity Score	Dactylitis score based upon digit tenderness for each digit of hands and feet, ranges from 0-60	Month 1, Month 3, Month 6, Month 9, Month 12	No
Secondary	Enthesitis score based upon SPARCC (Spondyloarthritis Research Consortium) and Leeds indices	Enthesitis score based upon presence/absence of enthesitis at 16 sites (SPARCC) or 6 sites (Leeds)	Month 1, Month 3, MOnth 6, Month 9, Month 12	No
Secondary	36-Item Short-Form Health Survey (SF-36)	SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).	Month 1, Month 3, Month 6, Month 9, Month 12	No
Secondary	Euro Quality of Life (EQ-5D)- Health State Profile Utility Score at Week X	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (	Month 1, Month 3, Month 6, Month 9, Month 12	No
Secondary	Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)	FACIT: participant rated questionnaire to assess fatigue	Month 1, Month 3, Month 6, Month 9, Month 12	No
Secondary	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	BASDAI is a validated self assessment too used to determine disease activity in participants with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale of 0-10 (0=none and 10=very severe) participants answer 6 questions measuring discomfort, pain, and fatigue. The final BASDAI score averages the individual assessments for a final score ranging 0-10.	Month 1, Month 3, Month 6, Month 9, Month 12	No

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