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Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis (OPAL BALANCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01976364
Recruitment Status : Completed
First Posted : November 5, 2013
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief 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.


Condition or disease Intervention/treatment Phase
Arthritis, Psoriatic Drug: Tofacitinib Drug: Methotrexate Drug: Placebo Methotrexate Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 873 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: The sub-study will be participant, care provider, investigator and outcomes assessor masked.
Primary Purpose: Treatment
Official Title: A LONG-TERM, OPEN-LABEL EXTENSION STUDY OF TOFACITINIB (CP-690,550) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
Actual Study Start Date : February 17, 2014
Actual Primary Completion Date : May 20, 2019
Actual Study Completion Date : May 20, 2019


Arm Intervention/treatment
Experimental: Tofacitinib Drug: Tofacitinib
Tofacitinib 5 mg tablet twice daily

Drug: Tofacitinib
Tofactinib 10 mg tablet twice daily

Drug: Methotrexate
Methotrexate 7.5-20 mg weekly
Other Name: Sub-study

Drug: Placebo Methotrexate
Placebo to match active methotrexate orally once a week
Other Name: Sub-study




Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Month 36 ]
    Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

  2. Number of Participants With Laboratory Test Values of Potential Clinical Importance [ Time Frame: Baseline up to Month 36 ]
    Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.


Secondary Outcome Measures :
  1. Number of Participants With an American College of Rheumatology 20% (ACR20) Response [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21. Month 24, Month 27, Month 30, Month 33, Month 36 ]
    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).

  2. Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36 ]
    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.

  3. Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21. Month 24, Month 27, Month 30, Month 33, Month 36 ]
    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.

  4. Score on Health Assessment Questionnaire- Disability Index [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33. Month 36 ]
    Score on Health Assessment Questionnaire-Disability Index patient reported outcome

  5. Number of participants achieving Psoriatic Arthritis Response Criteria (PsARC) [ Time Frame: Month 1, Month 3, Month 6. Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36 ]
    PsARC is comprised of 4 clinical improvement criteria: 1 unit improvement on Physician Global Assessment: 20% (0-100 scale) improvement on the participant assessments; and 30% reduction in 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

  6. Physician's Global Assessment of Psoriasis score [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21. Month 24, Month 27, Month 30, Month 33, Month 36 ]
    PGA Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease).

  7. Psoriasis Area and Severity Index 75 (PASI) [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36 ]
    Proportion of subjects achieving at least a 75% reduction in PASI relative to baseline and PASI component scores

  8. Dactylitis severity score [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36 ]
    Dactylitis score is based upon digit tenderness for each digit of hands and feet ranges from 0-60.

  9. Enthesitis score based upon SPARCC (Spondylitis Research Consortium) and Leeds indices [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36 ]
    Enthesitis score is based upon presence/absence of enthesitis at 16 sites (SPARCC) or 6 sites (Leeds)

  10. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36 ]
    BASDAI is a validated self-assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS) utilizing a visual analogue scale of 0-10 (0=none and 10=very severe). Answers to six questions measuring are averaged for a final score ranging from 0-10.

  11. 36-Item Short-Form Health Survey (SF-36) [ Time Frame: Month 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 ]
    SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

  12. Euro Quality of Life (EQ-5D)- Health State Profile Utility Score (EQ-5D) [ Time Frame: Month 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 ]
    EQ5D is a 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; 1 indicates better health state (no problems) and 3 indicates worst health state.

  13. Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) [ Time Frame: Month 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 ]
    FACIT-F is a participant rated questionnaire to assess fatigue


Other Outcome Measures:
  1. Exploratory Primary Measure of Sub-study: Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Month 6 ]
    Change in score from the baseline visit in the sub-study of the Health Assessment Questionnaire-Disability Index

  2. Exploratory Primary Measure of Sub-study: Change from Baseline in the Psoriatic Arthritis Disease Activity Score [ Time Frame: Month 6 ]
    Change in PASDAS from the baseline visit in the sub-study

  3. Exploratory Secondary Measure of Sub-study: HAQ-DI [ Time Frame: Month 1, Month 3, Month 9, Month 12 ]
    Change from baseline HAQ-DI score in the sub-study

  4. Exploratory Secondary Measure of Sub-study: PASDAS [ Time Frame: Month 1, Month 3, Month 9, Month 12 ]
    Change from Baseline in PASDAS in the sub-study

  5. Exploratory Secondary Measure of Sub-study: Physician's Global Assessment of Psoriasis (PGA-PsO) score [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12, Follow-up ]
    PGA -PsO ranges from 0 (no psoriasis) to 5 (severe disease).

  6. Exploratory Secondary Measure of the Sub-study: Number of subject achieving Psoriatic Arthritis Response Criteria (PsARC) [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12 ]
    PsARC is comprised of 4 clinical improvement criteria: 1 unit improvement on Physician Global Assessment: 20% (0-100 scale) improvement on the participant assessments; and 30% reduction in 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

  7. Exploratory Secondary Measure of Sub-study: Body Surface Area (BSA) [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12 ]
    Percent change from baseline of the BAS in the sub-study.

  8. Exploratory Secondary Measure of Sub-study: Dactylitis Severity Score [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12 ]
    Change from baseline in the sub-study of the Dactylitis Severity Score. Dactyltis score based upon digit tenderness for each digit of hands and feet ranges from 0-60

  9. Exploratory Secondary Measure of Sub-study: Number of subjects with an absence of dactylitis [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12 ]
    Utilizing the Dactylitis Severity Score results, the number of subjects in the sub-study without dactylitis noted.

  10. Exploratory Secondary Measure of Sub-study: Leeds Enthesitis Index Score [ Time Frame: Month 1, Month 3, Month 6, Month 12 ]
    Change from baseline in the sub-study of the Leeds Enthesitis Index. Leeds Enthesitis score based upon presence/absence of enthesitis of 6 sites.

  11. Exploratory Secondary Measure of Sub-study: Absence of Enthesitis using the Leeds Enthesitis Index [ Time Frame: Month 1, Month 3, Month 6, Month 12 ]
    Utilizing the Leeds Enthesitis Index results, the number of subjects in the sub-study without enthesitis.

  12. Exploratory Secondary Measure of Sub-study: Number of subjects achieving a Minimal Disease Activity (MDS) Response [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12 ]
    A psoriatic arthritis subject is defined as meeting MDA when 5 or greater of the 7 criteria are met: 1) tender/painful joint count < or equal to 1; 2) swollen joint count < or equal to 1; 3) BSA < or equal to 3%; 4) Patient Assessment of Arthritis Pain (by visual analog scale[VAS]) < or equal to 15 mm; 5) Patient Global Assessment of Arthritis VAS < or equal to 20 mm; 6) HAQ-DI < or equal to 0.5; 7) Leeds Enthesitis Index < or equal to 1.

  13. Exploratory Secondary Measure of Sub-study: Change in ACR components [ Time Frame: Month 1, Month 3, Month 6, Month 9, Month 12 ]
    HAQ-DI, CRP, Patient's Assessment of Arthritis Pain, Patient's Global Assessment of Arthritis, Physician's Global Assessment of Arthritis, swollen joint count, tender/painful joint count

  14. Exploratory Secondary Measure of Sub-study: Change in 36-Item Short-Form Health Survey (SF-36) [ Time Frame: Month 1, Month 3, Month 6, Month 12 ]
    SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).

  15. Exploratory Secondary Measure in Sub-study: Change in Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-F) [ Time Frame: Month 1, Month 3, Month 6, Month 12 ]
    FACIT-F is a participant rated questionnaire to assess fatigue

  16. Exploratory Secondary Measure in Sub-study: Change in Euro Quality of Life - Health State Profile Utility Score (EQ-5D) [ Time Frame: Month 1, Month 3, Month 6, Month 12 ]
    EQ5D is a 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; 1 indicates better health state (no problems) and 3 indicates worst health state.

  17. Exploratory Secondary Measure in Sub-study: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline to Month 12 in Sub-study ]
    Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

  18. Exploratory Secondary Measure in Sub-study: Number of Participants With Laboratory Test Values of Potential Clinical Importance [ Time Frame: Baseline to Month 12 in Sub-study ]
    Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01976364


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Locations
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United States, Alabama
Rheumatology Associates, PC
Birmingham, Alabama, United States, 35205
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, United States, 35801
United States, Arizona
Arizona Arthritis & Rheumatology Associates, P.C.
Glendale, Arizona, United States, 85306
United States, California
St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
Fullerton, California, United States, 92835
Desert Medical Advances
Palm Desert, California, United States, 92260
San Diego Arthritis Medical Clinic
San Diego, California, United States, 92108
Stanford Hospital and Clinics
Stanford, California, United States, 94305
United States, Connecticut
New England Research Associates, LLC
Bridgeport, Connecticut, United States, 06606
United States, Florida
Rheumatology Associates of Central Florida, PA
Orlando, Florida, United States, 32806
Millennium Research
Ormond Beach, Florida, United States, 32174
Arthritis Center, Inc.
Palm Harbour, Florida, United States, 34684
Integral Rheumatology and Immunology Specialists
Plantation, Florida, United States, 33324
Florida Medical Clinic, P.A.
Zephyrhills, Florida, United States, 33542
United States, Idaho
St. Luke's Clinic - Rheumatology
Boise, Idaho, United States, 83702
St. Luke's Intermountain Research Center
Boise, Idaho, United States, 83702
United States, Kentucky
Bluegrass Community Research, Inc.
Lexington, Kentucky, United States, 40504
United States, Maryland
Klein and Associates, M.D., P.A.
Hagerstown, Maryland, United States, 21740
The Center for Rheumatology and Bone Research
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States, 01605
United States, Minnesota
St. Paul Rheumatology, P.A.
Eagan, Minnesota, United States, 55121
United States, Missouri
Clayton Medical Research
Saint Louis, Missouri, United States, 63117
United States, Nebraska
Physician Research Collaboration, LLC
Lincoln, Nebraska, United States, 68516
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, Ohio
Cincinnati Rheumatic Disease Study Group, Inc.
Cincinnati, Ohio, United States, 45242
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, United States, 44130
United States, Pennsylvania
East Penn Rheumatology Associates, PC
Bethlehem, Pennsylvania, United States, 18015
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology
Summerville, South Carolina, United States, 29486
United States, Tennessee
Arthritis Clinic
Jackson, Tennessee, United States, 38305
West Tennessee Research Institute
Jackson, Tennessee, United States, 38305
United States, Texas
Adriana Pop-Moody MD Clinic PA
Corpus Christi, Texas, United States, 78404
Pioneer Research Solutions, Inc.
Cypress, Texas, United States, 77429
United States, Utah
Investigational Drug Services
Salt Lake City, Utah, United States, 84112
University of Utah Hospital & Clinics
Salt Lake City, Utah, United States, 84132
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98104
Seattle Rheumatology Associates
Seattle, Washington, United States, 98122
Swedish Medical Center
Seattle, Washington, United States, 98122
Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Australia, Queensland
Rheumatology Research Unit
Maroochydore, Queensland, Australia, 4558
Pacific Private Clinic
Southport, Queensland, Australia, 4215
Australia, Victoria
Emeritus Research Pty Ltd
Camberwell, Victoria, Australia, 3124
Emeritus Research
Camberwell, Victoria, Australia, 3124
St. Vincent's Hospital
Fitzroy, Victoria, Australia, 3065
Belgium
Hopital Erasme - Clinique Universitaire de Bruxelles
Brussels, Brabant Flamand, Belgium, 1070
Hopital Erasme - Clinique Universitaire de Bruxelles
Brussels, Belgium, 1070
Reumaclinic
Genk, Belgium, 3600
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
University Hospital Leuven
Leuven, Belgium, 3000
ZNA Jan Palfijn
Merksem, Belgium, 2170
Brazil
CMIP - Centro Mineiro de Pesquisa Ltda / CETAL - Centro de Estudos e Tratamiento de Aparelho
Juiz de Fora, MG, Brazil, 36010-570
EDUMED - Educação em Saùde SS Ltda
Curitiba, PR, Brazil, 80440-080
Hospital de Clinicas de Porto Alegre (HCPA) / UFRGS
Porto Alegre, RS, Brazil, 90035-903
Bulgaria
UMBAL Dr. Georgi Stranski EAD
Pleven, Bulgaria, 5800
UMHAT Dr.Georgi Stranski EAD
Pleven, Bulgaria, 5800
Multiprofile Hospital for Active Treatment - Plovdiv AD
Plovdiv, Bulgaria, 4000
Multiprofile hospital for active treatment Kaspela EOOD
Plovdiv, Bulgaria, 4002
Medical Center - "New rehabilitation center" EOOD
Stara Zagora, Bulgaria, 6003
Canada, Ontario
K. Papp Clinical Research
Waterloo, Ontario, Canada, N2J 1C4
Czechia
X-Medica, s.r.o.
Brno, Czechia, 613 00
Revmacentrum MUDr. Mostera, s.r.o.
Brno, Czechia, 615 00
Stavovska, s.r.o.
Brno, Czechia, 638 00
Revmatologie s.r.o.
Brno, Czechia, 63800
Vesalion s.r.o.
Ostrava, Czechia, 702 00
Revmatologicky Ustav - Lekarna
Praha 2, Czechia, 128 50
Revmatologicky ustav
Praha 2, Czechia, 128 50
Revmatologicka ambulance
Praha 4, Czechia, 140 00
MEDICAL PLUS, s.r.o.
Uherske Hradiste, Czechia, 686 01
Germany
Rheumazentrum Prof. Dr. med Gunther Neeck
Bad Doberan, Mecklenburg-vorp, Germany, 18209
Charite Universitaetsmedizin Berlin
Berlin, Germany, 10117
Klinische Forschung Berlin-Mitte GmbH
Berlin, Germany, 10117
Rheumapraxis Steglitz
Berlin, Germany, 12161
Schlosspark-Klinik
Berlin, Germany, 14059
CIRI, Centrum fuer innovative Diagnostik und Therapie Rheumatologie und Immunologie (GmbH)
Frankfurt am Main, Germany, 60598
Medizinische Universitaetsklinik Freiburg
Freiburg, Germany, 79106
Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes
Homburg, Germany, 66421
University Hospital of Cologne
Koeln, Germany, 50937
Elisabeth Klinik Bigge
Olsberg, Germany, 59939
Hungary
Diagnoscan Magyarország Kft.
Budapest, Hungary, 1024
Budapest Fovaros II. keruleti Onkormanyzat Egeszsegugyi Szolgalata- Rontgen- Ultrahang
Budapest, Hungary, 1027
Revita Reumatologiai Rendelo
Budapest, Hungary, 1027
Qualiclinic Kft.
Budapest, Hungary, 1036
Magyar Honvedseg Egeszsegugyi Kozpont - Kozponti Radiologiai Diagnosztika Osztaly
Budapest, Hungary, 1062
Magyar Honvedseg Egeszsegugyi Kozpont, Reumatologiai Osztaly
Budapest, Hungary, 1062
Csolnoky Ferenc Korhaz, Reumatologiai Osztaly
Veszprem, Hungary, 8200
Mexico
Hospital Angeles Clinica Londres
Mexico City, D.F, Mexico, 06700
Grupo Medico Camino S.C.
Mexico City, Distrito Federal, Mexico, 03310
Cliditer, S.A. DE C.V.
Mexico City, Distrito Federal, Mexico, 06700
Centro Integral en Reumatologia S.A. de C.V.
Guadalajara, Jalisco, Mexico, 44160
Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C.
Culiacan, Sinaloa, Mexico, 80000
Sanatorio CEMSI Chapultepec
Culiacan, Sinaloa, Mexico, 80040
Hospital General de Culiacan Dr. Bernardo J. Gastelum
Culiacan, Sinaloa, Mexico, 80230
Instituto Medico Panamericano, S.A de C.V.
Merida, Yucatan, Mexico, 97000
Unidad Reumatologica Las Americas SCP
Merida, Yucatan, Mexico, 97000
Centro Multidisciplinario Para El Desarrollo Especializado De La Investigacion Clinica En Yucatan
Merida, Yucatan, Mexico, 97130
Christus Muguerza del Parque S.A. de C.V.
Chihuahua, Mexico, 31000
Investigacion y Biomedicina de Chihuahua SC
Chihuahua, Mexico, 31000
Poland
Synexus Polska Sp. z o.o. Oddzial we Wroclawiu
Wroclaw, Dolnoslaskie, Poland, 50-088
Centrum Medyczne Pratia S.A. Warszawa
Warszawa, Mazowieckie, Poland, 01-868
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Chirurgiczna dla Dzieci "PriamaMed" Sp.P.
Bialystok, Poland, 15-002
Zdrowie Osteo-Medic s.c. L. i A. Racewicz, A. i J. Supronik
Bialystok, Poland, 15-351
ClinicMed Badurski i wspolnicy Spolka Jawna
Bialystok, Poland, 15-879
ClinicMed Daniluk, Nowak Spolka Jawna
Bialystok, Poland, 15-879
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
Bydgoszcz, Poland, 85-168
Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka partnerska
Elblag, Poland, 82-300
Centrum Radiologii
Elblag, Poland, 82-300
NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela
Elblag, Poland, 82-300
Wojewodzki Szpital Zespolony, Zaklad Radiologii
Elblag, Poland, 82-300
Przychodnia Specjalistyczna Lekarskiej Spoldzielni Pracy "Medica"
Grodzisk Mazowiecki, Poland, 05-825
Specjalistyczne Gabinety Lekarskie "DERMED" Anna Kaszuba
Lodz, Poland, 90-265
Zespol Poradni Specjalistycznych Reumed Filia Onyksowa
Lublin, Poland, 20-582
Top-Medical Sp. z o. o.
Lublin, Poland, 20-601
NZOZ Lecznica MAK-MED s.c.
Nadarzyn, Poland, 05-830
Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
Poznan, Poland, 61-397
NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu
Torun, Poland, 87-100
Rheuma-Medicus Zaklad Opieki Zdrowotnej
Warszawa, Poland, 02-118
ARS RHEUMATICA - Centrum Reumatologii NZOZ
Warszawa, Poland, 02-691
Russian Federation
Republic State Budgetary Health Care Institution of Karelia Republic
Petrozavodsk, Karelia Republic, Russian Federation, 185019
State Autonomic Healthcare Institution ''City Clinical Hospital # 7''
Kazan, Republic OF Tatarstan, Russian Federation, 420103
SBIH of Moscow "City Clinical Hospital #1 n. a. N.I. Pirogov" of the Healthcare Department of Moscow
Moscow, Russian Federation, 119049
Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"
Novosibirsk, Russian Federation, 630099
Local Ethics Committee of OOO City Neurological Centre "Sibneiromed"
Novosibirsk, Russian Federation
State Institution of Healthcare Regional Clinical Hospital
Saratov, Russian Federation, 410053
State Budget Educational Institution of Highest Professional Education
Tomsk, Russian Federation, 634050
State Autonomous Healthcare Institution of Yaroslavl region Clinical Hospital of Emergency
Yaroslavl, Russian Federation, 150003
State Autonomous Healthcare lnstitution of Yaroslavl Region "Clinical Hospital of Emergency Medical
Yaroslavl, Russian Federation, 150003
Slovakia
Nestatna reumatologicka ambulancia
Bratislava, Slovakia, 841 04
MEDMAN s.r.o. - reumatologicka ambulancia
Martin, Slovakia, 03601
REUMEX, s.r.o
Rimavska Sobota, Slovakia, 979 01
Spain
Hospital Clinico de Santiago
Santiago de Compostela, A Coruna, Spain, 15706
Corporacio Sanitaria Parc Tauli
Sabadell, Barcelona, Spain, 08208
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008
Complexo Hospitalario Universitario A Coruna
A Coruna, Spain, 15006
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41009
Hospital Quiron Salud Infanta Luisa
Sevilla, Spain, 41010
Hospital Universitario y Politecnico La Fe
Valencia, Spain, 46026
Taiwan
Buddhist Dalin Tzu Chi General Hospital
Chia-Yi, Taiwan, 62247
Chang Gung Medical Foundation-Kaohsiung Branch
Kaohsiung City, Taiwan, 83301
Chung Shan Medical University Hospital
Taichung, Taiwan, 40201
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
United Kingdom
Barking Havering and Redbridge University Hospital NHS Trust-King George Hospital
Goodmayes, Essex, United Kingdom, IG3 8YB
Barking Havering and Redbridge University Hospitals NHS Trust
Romford, Essex, United Kingdom, RM7 0AG
The Dudley Group NHS Foundation Trust
Dudley, WEST Midlands, United Kingdom, DY1 2HQ
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, WEST Yorkshire, United Kingdom, BD5 0NA
Wirral University Teaching Hospital NHS Foundation Trust
Upton, Wirral, United Kingdom, CH49 5PE
Royal United Hospitals NHS Foundation Trust
Bath, United Kingdom, BA1 1 RL
York Teaching Hospital NHS Foundation Trust
York, United Kingdom, YO31 8HE
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01976364     History of Changes
Other Study ID Numbers: A3921092
2011-002169-39 ( EudraCT Number )
OPAL BALANCE ( Other Identifier: Alias Study Number )
First Posted: November 5, 2013    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Tofacitinib
Psoriatic Arthritis
Xeljanz
CP-690550
Jak-inhibitor
oral treatment
psoriasis
OPAL BALANCE
methotrexate
pruritus
itch
DLQI
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Methotrexate
Tofacitinib
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Protein Kinase Inhibitors