Clinical trial NCT01976364: Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis
Official title: A LONG-TERM, OPEN-LABEL EXTENSION STUDY OF TOFACITINIB (CP-690,550) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Psoriatic
Keywords: Tofacitinib
Psoriatic Arthritis
Xeljanz
CP-690550
Jak-inhibitor
oral treatment
psoriasis
OPAL BALANCE
methotrexate
pruritus
itch
DLQI
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-11-05
Enrollment: 686
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)
measure: Number of Adverse Events (AEs) by Severity
timeFrame: Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)
measure: Number of Participants With Abnormal Clinical Laboratory Values
timeFrame: Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)
measure: Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values
timeFrame: Date of first dose of study medication (Baseline) up to 48 months (36 months of main study and 12 months of sub-study)
measure: Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6
timeFrame: Sub-study: Baseline (Day 1), Month 6
measure: Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6
timeFrame: Sub-study: Baseline (Day 1), Month 6
Secondary outcomes:
measure: Main Study: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response
timeFrame: Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
measure: Main Study: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response
timeFrame: Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
measure: Main Study: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response
timeFrame: Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
measure: 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
timeFrame: Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
measure: Main Study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)
timeFrame: Main Study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
measure: 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
timeFrame: Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
measure: 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
timeFrame: Main study: Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
measure: 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
timeFrame: Main study: Baseline, Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
measure: 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
timeFrame: Main study: Baseline(Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
measure: 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
timeFrame: Main study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
measure: 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
timeFrame: Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
measure: 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
timeFrame: Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
measure: 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
timeFrame: Main study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
measure: 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
timeFrame: Main Study: Baseline (Day 1), Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36
measure: 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
timeFrame: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
measure: 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
timeFrame: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
measure: 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
timeFrame: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
measure: 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
timeFrame: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
measure: 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
timeFrame: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
measure: 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
timeFrame: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
measure: 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
timeFrame: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
measure: 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
timeFrame: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
measure: 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
timeFrame: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
measure: 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
timeFrame: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
measure: 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
timeFrame: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30 and 36
measure: 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
timeFrame: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
measure: 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
timeFrame: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
measure: 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
timeFrame: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
measure: 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
timeFrame: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
measure: 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
timeFrame: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
measure: 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
timeFrame: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
measure: 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
timeFrame: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
measure: 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
timeFrame: Main Study: Baseline (Day 1), Months 1, 6, 12, 18, 24, 30, and 36
measure: Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Months 1, 3, 9 and 12
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 9 and 12
measure: Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Months 1, 3, 9 and 12
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 9 and 12
measure: Sub-study: Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) at Months 1, 3, 6, 9 and 12
timeFrame: Months 1, 3, 6, 9 and 12
measure: 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
timeFrame: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: 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
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: Sub-study: Change From Baseline in Dactylitis Severity Score (DSS) (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: Sub-study: Percentage of Participants With Absence of Dactylitis (For Participants With Baseline DSS >0) at Months 1, 3, 6, 9 and 12
timeFrame: Sub-study: Months 1, 3, 6, 9 and 12
measure: Sub-study: Change From Baseline in Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI >0) at Months 1, 3, 6, 9 and 12
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: Sub-study: Leeds Enthesitis Index (LEI) (For Participants With Baseline LEI =0) at Months 1, 3, 6, 9 and 12
timeFrame: Sub-study: Months 1, 3, 6, 9 and 12
measure: 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
timeFrame: Sub-study: Months 1, 3, 6, 9 and 12
measure: Sub-study: Percentage of Participants With Minimal Disease Activity (MDA) at Months 1, 3, 6, 9 and 12
timeFrame: Sub-study: Months 1, 3, 6, 9 and 12
measure: Sub-study: Change From Baseline in Tender/Painful Joint Count at Months 1, 3, 6, 9 and 12
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: Sub-study: Change From Baseline in Swollen Joint Count at Months 1, 3, 6, 9 and 12
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: Sub-study: Change From Baseline in Physician's Global Assessment of Arthritis (PhyGA) at Months 1, 3, 6, 9 and 12
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: Sub-study: Change From Baseline in Patient's Global Assessment of Arthritis (PtGA) at Months 1, 3, 6, 9 and 12
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: Sub-study: Change From Baseline in Patient's Assessment of Arthritis Pain at Months 1, 3, 6, 9 and 12
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: Sub-study: Change From Baseline in C-Reactive Protein (CRP) at Months 1, 3, 6, 9 and 12
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: 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
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: 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
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: 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
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: 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
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: 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
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: 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
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: 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
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: 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
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: 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
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: 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
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: 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
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: 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
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: 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
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: 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
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: 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
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: 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
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: Sub Study: Change From Baseline in EuroQol-5D Health Questionnaire 3-Level (EQ-5D-3L) Pain/Discomfort Domain
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: 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
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
measure: 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
timeFrame: Sub-study: Baseline (Day 1), Months 1, 3, 6, 9 and 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Rheumatology Associates, PC
state: Alabama
city: Huntsville
country: United States
facility: Rheumatology Associates of North Alabama, PC
state: Alabama
city: Glendale
country: United States
facility: Arizona Arthritis & Rheumatology Associates, P.C.
state: Arizona
city: Fullerton
country: United States
facility: St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: San Diego
country: United States
facility: San Diego Arthritis Medical Clinic
state: California
city: Stanford
country: United States
facility: Stanford Anatomic Pathology and Clinical Lab
state: California
city: Stanford
country: United States
facility: Stanford Health Care Department of Pharmacy lnvestigational Drug Services
state: California
city: Stanford
country: United States
facility: Stanford University Hospitals and Clinics
state: California
city: Bridgeport
country: United States
facility: New England Research Associates, LLC
state: Connecticut
city: Orlando
country: United States
facility: Rheumatology Associates of Central Florida, PA
state: Florida
city: Ormond Beach
country: United States
facility: Millennium Research
state: Florida
city: Palm Harbour
country: United States
facility: Arthritis Center, Inc.
state: Florida
city: Plantation
country: United States
facility: Guillermo Valenzuela, MD PA dba Integral Rheumatology & Immunology Specialists
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, P.A.
state: Florida
city: Boise
country: United States
facility: St. Luke's Clinic - Rheumatology
state: Idaho
city: Boise
country: United States
facility: St. Luke's Intermountain Research Center
state: Idaho
city: Lexington
country: United States
facility: Bluegrass Community Research, Inc.
state: Kentucky
city: Hagerstown
country: United States
facility: Klein and Associates, M.D., P.A.
state: Maryland
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: Eagan
country: United States
facility: St. Paul Rheumatology, P.A.
state: Minnesota
city: Saint Louis
country: United States
facility: Clayton Medical Research
state: Missouri
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Cincinnati
country: United States
facility: Cincinnati Rheumatic Disease Study Group, Inc.
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland Medical Center
state: Ohio
city: Middleburg Heights
country: United States
facility: Paramount Medical Research & Consulting, LLC
state: Ohio
city: Bethlehem
country: United States
facility: East Penn Rheumatology Associates, PC
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Summerville
country: United States
facility: Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology
state: South Carolina
city: Jackson
country: United States
facility: Arthritis Clinic
state: Tennessee
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Corpus Christi
country: United States
facility: Adriana Pop-Moody MD Clinic PA
state: Texas
city: Cypress
country: United States
facility: Pioneer Research Solutions, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: Investigational Drug Services
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Hospital & Clinics
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Hospitals and Clinics - Clinie 2
state: Utah
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Seattle
country: United States
facility: Seattle Rheumatology Associates
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Maroochydore
country: Australia
facility: Rheumatology Research Unit
state: Queensland
city: Southport
country: Australia
facility: Pacific Private Clinic
state: Queensland
city: Camberwell
country: Australia
facility: Emeritus Research
state: Victoria
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital (Melbourne)
state: Victoria
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital
state: Victoria
city: Brussels
country: Belgium
facility: Hopital Erasme - Clinique Universitaire de Bruxelles
state: Brabant Flamand
city: Brussels
country: Belgium
facility: Hopital Erasme - Clinique Universitaire de Bruxelles
city: Genk
country: Belgium
facility: Reumaclinic
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Merksem
country: Belgium
facility: ZNA Jan Palfijn
city: Juiz de Fora
country: Brazil
facility: CMIP- Centro Mineiro de Pesquisa Ltda/CETAL- Centro de Estudos e Tratamento do Aparelho Locomotor
state: MG
city: Curitiba
country: Brazil
facility: EDUMED - Educação em Saùde SS Ltda
state: PR
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre (HCPA) / UFRGS
state: RS
city: Pleven
country: Bulgaria
facility: UMHAT "Dr. G. Stranski" EAD, Department of Rheumatology
city: Plovdiv
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Plovdiv AD
city: Plovdiv
country: Bulgaria
facility: Multiprofile hospital for active treatment Kaspela EOOD
city: Stara Zagora
country: Bulgaria
facility: Medical Center - "New rehabilitation center" EOOD
city: Waterloo
country: Canada
facility: K. Papp Clinical Research
state: Ontario
city: Brno
country: Czechia
facility: X-Medica, s.r.o.
city: Brno
country: Czechia
facility: Revmacentrum MUDr. Mostera, s.r.o.
city: Brno
country: Czechia
facility: Stavovska, s.r.o.
city: Brno
country: Czechia
facility: Revmatologie s.r.o.
city: Ostrava
country: Czechia
facility: Vesalion s.r.o.
city: Praha 2
country: Czechia
facility: Revmatologicky ustav - Lekarna
city: Praha 2
country: Czechia
facility: Revmatologicky ustav
city: Praha 4
country: Czechia
facility: Revmatologicka ambulance
city: Uherske Hradiste
country: Czechia
facility: MEDICAL PLUS, s.r.o.
city: Bad Doberan
country: Germany
facility: Rheumazentrum Prof. Dr. med Gunther Neeck
state: Mecklenburg-vorp
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin
city: Berlin
country: Germany
facility: Klinische Forschung Berlin-Mitte GmbH
city: Berlin
country: Germany
facility: Rheumapraxis Steglitz
city: Berlin
country: Germany
facility: Schlosspark-Klinik
city: Frankfurt am Main
country: Germany
facility: CIRI, Centrum fuer innovative Diagnostik und Therapie Rheumatologie und Immunologie (GmbH)
city: Freiburg
country: Germany
facility: Medizinische Universitaetsklinik Freiburg
city: Homburg
country: Germany
facility: Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes
city: Koeln
country: Germany
facility: University Hospital of Cologne
city: Olsberg
country: Germany
facility: Elisabeth Klinik Bigge
city: Budapest
country: Hungary
facility: Diagnoscan Magyarország Kft.
city: Budapest
country: Hungary
facility: Budapest Fovaros II. keruleti Onkormanyzat Egeszsegugyi Szolgalata- Rontgen- Ultrahang
city: Budapest
country: Hungary
facility: Revita Reumatologiai Rendelo
city: Budapest
country: Hungary
facility: Qualiclinic Kft.
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont - Kozponti Radiologiai Diagnosztika Osztaly
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont, Reumatologiai Osztaly
city: Veszprem
country: Hungary
facility: Csolnoky Ferenc Korhaz, Reumatologiai Osztaly
city: Veszprem
country: Hungary
facility: Csolnoky Ferenc Korhaz
city: Mexico City
country: Mexico
facility: Hospital Angeles Clinica Londres
state: D.F
city: Mexico City
country: Mexico
facility: Grupo Medico Camino S.C.
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Cliditer, S.A. DE C.V.
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Centro Integral en Reumatologia S.A. de C.V.
state: Jalisco
city: Culiacan
country: Mexico
facility: Centro de Investigacion de Tratamientos Innovadores de Sinaloa, S.C.
state: Sinaloa
city: Culiacan
country: Mexico
facility: Sanatorio CEMSI Chapultepec
state: Sinaloa
city: Culiacan
country: Mexico
facility: Hospital General de Culiacan Dr. Bernardo J. Gastelum
state: Sinaloa
city: Merida
country: Mexico
facility: Instituto Medico Panamericano, S.A de C.V.
state: Yucatan
city: Merida
country: Mexico
facility: Unidad Reumatologica Las Americas S.C.P.
state: Yucatan
city: Merida
country: Mexico
facility: Centro Multidisciplinario Para El Desarrollo Especializado De La Investigacion Clinica En
state: Yucatan
city: Chihuahua
country: Mexico
facility: Christus Muguerza del Parque S.A. de C.V.
city: Chihuahua
country: Mexico
facility: Investigacion y Biomedicina de Chihuahua SC
city: Warszawa
country: Poland
facility: Centrum Medyczne Pratia S.A. Warszawa
state: Mazowieckie
city: Bialystok
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Chirurgiczna dla Dzieci "PriamaMed" Sp.P.
city: Bialystok
country: Poland
facility: Zdrowie Osteo-Medic s.c. L. i A. Racewicz, A. i J. Supronik
city: Bialystok
country: Poland
facility: ClinicMed Daniluk, Nowak Spolka Jawna
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy
city: Elblag
country: Poland
facility: Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka partnerska
city: Elblag
country: Poland
facility: Centrum Radiologii
city: Elblag
country: Poland
facility: NZOZ Centrum Reumatologiczne Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela
city: Elblag
country: Poland
facility: Wojewodzki Szpital Zespolony, Zaklad Radiologii
city: Grodzisk Mazowiecki
country: Poland
facility: Przychodnia Specjalistyczna Lekarskiej Spoldzielni Pracy "Medica"
city: Lodz
country: Poland
facility: Specjalistyczne Gabinety Lekarskie "DERMED" Anna Kaszuba
city: Lublin
country: Poland
facility: Zespol Poradni Specjalistycznych Reumed Filia Onyksowa
city: Lublin
country: Poland
facility: Top-Medical Sp. z o. o.
city: Nadarzyn
country: Poland
facility: NZOZ Lecznica MAK-MED s.c.
city: Poznan
country: Poland
facility: Prywatna Praktyka Lekarska Prof. UM dr hab. med. Pawel Hrycaj
city: Torun
country: Poland
facility: NZOZ Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna w Toruniu
city: Warszawa
country: Poland
facility: Rheuma-Medicus Zaklad Opieki Zdrowotnej
city: Warszawa
country: Poland
facility: Reumatika Centrum Reumatologii NZOZ
city: Wroclaw
country: Poland
facility: Synexus Polska Oddzial we Wroclawiu
city: Kazan
country: Russian Federation
facility: State Autonomic Healthcare Institution ''City Clinical Hospital # 7''
state: Republic OF Tatarstan
city: Moscow
country: Russian Federation
facility: SBIH of Moscow "City Clinical Hospital #1 n. a. N.I. Pirogov" of the Healthcare Department of Moscow
city: Novosibirsk
country: Russian Federation
facility: Research Institution of Fundamental and Clinical Immunology
city: Novosibirsk
country: Russian Federation
facility: Limited Liability Company Consultative Diagnostic Rheumatology Center "Healthy Joints"
city: Petrozavodsk
country: Russian Federation
facility: Regional State Budgetary Health Care Institution of Karelia Republic
city: Saratov
country: Russian Federation
facility: State Institution of Healthcare Regional Clinical Hospital
city: Tomsk
country: Russian Federation
facility: State Budget Educational Institution of Highest Professional Education
city: Yaroslavl
country: Russian Federation
facility: State Autonomous Healthcare lnstitution of Yaroslavl Region "Clinical Hospital of Emergency Medical
city: Yaroslavl
country: Russian Federation
facility: State Healthcare Institution of Yaroslavl Region Clinical Emergency Hospital n.a.N.V. Solovyev
city: Bratislava
country: Slovakia
facility: Nestatna reumatologicka ambulancia
city: Martin
country: Slovakia
facility: MEDMAN s.r.o. - reumatologicka ambulancia
city: Rimavska Sobota
country: Slovakia
facility: REUMEX, s.r.o
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico de Santiago
state: A Coruna
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: A Coruna
country: Spain
facility: Complexo Hospitalario Universitario A Coruna
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Quiron Salud Infanta Luisa
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe
city: Chia-Yi
country: Taiwan
facility: Buddhist Dalin Tzu Chi General Hospital
city: Kaohsiung City
country: Taiwan
facility: Chang Gung Medical Foundation-Kaohsiung Branch
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Goodmayes
country: United Kingdom
facility: Barking Havering and Redbridge University Hospital NHS Trust-King George Hospital
state: Essex
city: Romford
country: United Kingdom
facility: Barking Havering and Redbridge University Hospitals NHS Trust
state: Essex
city: Dudley
country: United Kingdom
facility: The Dudley Group NHS Foundation Trust
state: WEST Midlands
city: Bradford
country: United Kingdom
facility: Bradford Teaching Hospitals NHS Foundation Trust
state: WEST Yorkshire
city: Bradford
country: United Kingdom
facility: Bradford Royal lnfirmary, BTHFT
state: WEST Yorkshire
city: Upton
country: United Kingdom
facility: Wirral University Teaching Hospital NHS Foundation Trust
state: Wirral
city: Bath
country: United Kingdom
facility: Royal United Hospitals NHS Foundation Trust
city: York
country: United Kingdom
facility: York Teaching Hospital NHS Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Winthrop KL, Curtis JR, Yamaoka K, Lee EB, Hirose T, Rivas JL, Kwok K, Burmester GR. Clinical Management of Herpes Zoster in Patients With Rheumatoid Arthritis or Psoriatic Arthritis Receiving Tofacitinib Treatment. Rheumatol Ther. 2022 Feb;9(1):243-263. doi: 10.1007/s40744-021-00390-0. Epub 2021 Dec 6.
citation: Panaccione R, Isaacs JD, Chen LA, Wang W, Marren A, Kwok K, Wang L, Chan G, Su C. Characterization of Creatine Kinase Levels in Tofacitinib-Treated Patients with Ulcerative Colitis: Results from Clinical Trials. Dig Dis Sci. 2021 Aug;66(8):2732-2743. doi: 10.1007/s10620-020-06560-4. Epub 2020 Aug 20.
citation: Nash P, Coates LC, Kivitz AJ, Mease PJ, Gladman DD, Covarrubias-Cobos JA, FitzGerald O, Fleishaker D, Wang C, Wu J, Hsu MA, Menon S, Fallon L, Romero AB, Kanik KS. Safety and Efficacy of Tofacitinib in Patients with Active Psoriatic Arthritis: Interim Analysis of OPAL Balance, an Open-Label, Long-Term Extension Study. Rheumatol Ther. 2020 Sep;7(3):553-580. doi: 10.1007/s40744-020-00209-4. Epub 2020 Jun 6.
citation: Burmester GR, Curtis JR, Yun H, FitzGerald O, Winthrop KL, Azevedo VF, Rigby WFC, Kanik KS, Wang C, Biswas P, Jones T, Palmetto N, Hendrikx T, Menon S, Rojo R. An Integrated Analysis of the Safety of Tofacitinib in Psoriatic Arthritis across Phase III and Long-Term Extension Studies with Comparison to Real-World Observational Data. Drug Saf. 2020 Apr;43(4):379-392. doi: 10.1007/s40264-020-00904-9.
citation: Gladman DD, Charles-Schoeman C, McInnes IB, Veale DJ, Thiers B, Nurmohamed M, Graham D, Wang C, Jones T, Wolk R, DeMasi R. Changes in Lipid Levels and Incidence of Cardiovascular Events Following Tofacitinib Treatment in Patients With Psoriatic Arthritis: A Pooled Analysis Across Phase III and Long-Term Extension Studies. Arthritis Care Res (Hoboken). 2019 Oct;71(10):1387-1395. doi: 10.1002/acr.23930.