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Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

CP-690,550

Methotrexate

Placebo

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Tofacitinib, CP-690,550, Xeljanz, methotrexate withdrawal, withdrawal study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria

- Must be 18 years of age or older.

Have a score of 6 or greater on the 2010 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Rheumatoid Arthritis at and/or prior to Screening Visit.

Have ≥4 tender/painful joints on motion and ≥4 swollen joints (28 joint counts) at both Screening Visit and Baseline Visit (Visit 1).
Have moderate to severe disease activity as defined by CDAI>10 and DAS28-4(ESR) ≥3.2 at Baseline Visit.
Have taken an oral MTX treatment regimen (15-25mg/week) continuously for at least 4 months prior to the screening visit and has taken a stable weekly dose of oral MTX with supplemental folic acid or folinic acid for at least 4 weeks prior to the baseline visit (conversion from parenteral MTX to oral MTX will require stabilization of the treatment regimen for at least 1 month).
Subjects must screen negative for active tuberculosis or inadequately treated tuberculosis infection (active or latent).

Key Exclusion Criteria

Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children and female subjects of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 3 months after the last dose of investigational product.
Subjects with infection or infection history; subjects with any current malignancy or a history of malignancy (except adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ); subjects with history of, or current evidence for, severe gastrointestinal narrowing (pathologic or iatrogenic); and subjects with history of documented diverticulitis.
Subjects with a history of insufficient response to ≥2 biologics, regardless of the class.

Sites / Locations

Rheumatology Associates of North Alabama, PC
Arthrocare, Arthritiscare & Research, PC
SunValley Arthritis Center, Ltd.
CHI St. Vincent Medical Group Hot Springs
Med Investigations, Inc
HCP Clinical Research, LLC
Sierra Rheumatology
Pacific Arthritis Center Medical Group
Robin K. Dore, MD, Inc.
Inland Rheumatology and Osteoporosis Medical Group
Inland Rheumatology Clinical Trials, Inc.
Desert Valley Medical Group
AARDS Research Inc
RASF-Clinical Research Inc
Omega Research Consultants
University of Florida College of Medicine - Jacksonville - Rheumatology Research
University of Florida, Rheumatology at ACC
Center for Arthritis and Rheumatic Diseases
Jeffrey Alper, MD
Medallion Clinical Research Institute, LLC
Suncoast Clinical Research, Inc.
Florida Arthritis & Osteoporosis Center
Gulf Coast Medical Center
West Broward Rheumatology Associates, Inc.
USF Health Morsani Center for Advanced Healthcare
BayCare Medical Group, Inc
Institute of Arthritis Research
Quincy Medical Group
Beacon Medical Group Rheumatology Main Street
Diagnostic Rheumatology and Research, PC
Ochsner Clinic Baton Rouge
Phase III Clinical Research
Clinical Pharmacology Study Group
Bronson Internal Medicine and Rheumatology
Western Michigan University Homer Stryker MD
North Mississippi Medical Clinics, Inc. - Clinical Research
Arthritis & Osteoporosis Associates
Radnet
Arthritis, Rheumatic & Back Disease Associates, P.A.
Open MRI & Diagnostic Imaging of Wall
AAIR Research Center
Physicians East, PA
PMG Research of Salisbury
Trinity Health Center-Medical Arts
Group Health Associates
Cincinnati Rheumatic Disease Study Group, Inc.
STAT Research, Inc.
Health Research of Oklahoma
Oklahoma Medical Research Foundation (OMRF)
Lynn Health Science Institute
East Penn Rheumatology Associates, P.C.
Altoona Center for Clinical Research
Piedmont Arthritis Clinic
Articularis Healthcare Group dba ACME Research
Articularis Healthcare Group d/b/a Low Country Rheumatology
Pioneer Research Solutions, Inc.
Metroplex Clinical Research Center
Center for Arthritis and Rheumatic Diseases
Center for Arthritis and Rheumatic Diseases
Genesis Research Services Pty Ltd
Optimus Clinical Research Pty Ltd
Rheumatology Research Unit
Emeritus Research
ReumaClinic
AZ Delta
University Multiprofile Hospital for Active Treatment Dr. G. Stranski EAD
Multiprofile Hospital for Active Treatment - Plovdiv AD, Rheumatology Department
Multiprofile Hospital for Active Treatment Trimontium OOD
University Multiprofile Hospital for Active Treatment - Kaspela EOOD
National Multiprofile Transport Hospital Tsar Boris III
Medical Centre Synexus Sofia EOOD
CCBR Czech Brno, s.r.o.
LEKARNA LANCIER s.r.o.
Lekarna Na Lidicke
Revmacentrum MUDr. Mostera, s.r.o., Revmatologie a interna
CCBR Ostrava, s.r.o.
Lekarna Rezidence Nova Karolina
Revmatologicky ustav, Lekrna
Revmatologicky ustav
Lekarna Hradebni s.r.o.
MEDICAL PLUS, s.r.o. Revmatologicka a osteologicka ambulance
PV - MEDICAL s.r.o., Revmatologicka ambulance
Revmavita s.r.o, Lekarna
Hamburger Rheuma Forschungszentrum I
DRC Gyogyszervizsgalo Kozpont Kft.
Revita Rendelo
Qualiclinic Kft.
CRU Hungary Kft.
Clinical Trial Pharmacy, KyungHee University Hospital
KyungHee University Hospital
CTC Pharmacy, Seoul National University Hospital
Seoul National University Hospital
Konkuk University Medical Center
Clinical Trial Pharmacy, The Catholic University of Korea, Seoul St. Mary's Hospital
The Catholic University of Korea Seoul, St. Mary's Hospital
Centro de Investigacion y Tratamiento Reumatologico SC Consultorio Medico de Reumatologia (CINTRE)
Morales Vargas Centro de Investigacion SC (Consultorio Anexo)
Mary Mediatrix Medical Center
Far Eastern University - Nicanor Reyes Medical Foundation, Marian Medical Arts Bldg
Zdrowie OSTEO-MEDIC s.c. L i A. Racewicz, A i J. Supronik
ClinicMed Daniluk, Nowak. Sp. j.
Nzoz Bif - Med
Centrum Medyczne Pratia Krakow
Malopolskie Centrum Medyczne S.C.
NZOZ Lecznica MAK-MED. S.C.
MTZ Clinical Research Sp. z o.o.
Federal State Budgetary Scientific Institution "Research Institute of Rheumatology
FSBEI HE "Orenburg State Medical University" of MoH RF
FSBEI HE "Orenburg State Medical University" of MoH RF
SPb SBIH "Consultative-Diagnostic Centre #85"
FSBIH "Clinical Hospital #122 n.a. L.G. Sokolov" of FMBA of Russia
SBIH "Samara Regional Clinical Hospital n.a. V.D. Seredavin"
NSHI "Departmental Hospital at Smolensk station OJSC "Russian Railways"
SAHI YR Clinical Hospital of Emergency Medical Care n.a. N.V. Soloviev
State Budgetary Institution of Healthcare of Yaroslavl Region "Regional Clinical Hospital"
AAGS s.r.o.
MEDMAN s.r.o.
REUMACENTRUM s.r.o.
MUDr. Zuzana Cizmarikova, s.r.o.
Reumex s.r.o
St. Augustine's Hospital
Complejo Hospitalario Universitario de Santiago
Hospital Universitario de Cruces
Hospital Infanta Luisa
Countess of Chester Hospital NHS Foundation Trust
Pharmacy (dispensary)
Countess of Chester Hospital NHS Foundation Trust
Hampshire Hospitals NHS Foundation Trust
Pharmacy, Hampshire Hospitals NHS Foundation Trust
Department of Rheumatology, Wirral University Teaching Hospital NHS Foundation Trust
Pharmacy Department, Wirral University Teaching Hospital NHS Foundation Trust
Wirral University Teaching Hospital NHS Foundation Trust
Pharmacy Department
The Dudley Group NHS Foundation Trust
Pharmacy
University Hospital of South Manchester NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CP-690,550 and methotrexate

CP-690,550 and placebo

Arm Description

Open-label tofacitinib tablet and blinded methotrexate capsule

open-label tofacitinib tablet and blinded matching placebo for methotrexate capsule

Outcomes

Primary Outcome Measures

Double Blind Phase: Change From Randomization in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (Erythrocyte Sedimentation Rate [ESR]) at Week 48

DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joints count, ESR (millimeters per hour [mm/hr]) and participant global assessment of arthritis (PtGA) on a 100 millimeter (mm) visual analog scale (VAS: scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicate worse health condition). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (ESR) less than (<) 2.6 implied remission. DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*In(ESR in mm/hour) + 0.014*PtGA in mm; ln = natural logarithm, sqrt = square root of.

Secondary Outcome Measures

Double Blind Phase: Change From Randomization in DAS28-4 ESR at Week 36

DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and PtGA on a 100 millimeter (mm) VAS (VAS: scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicate worse health condition). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (<=) 3.2 implied low disease activity and greater than (>) 3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (ESR) less than (<) 2.6 implied remission. DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*In(ESR in mm/hour) + 0.014*PtGA in mm; ln = natural logarithm, sqrt = square root of.

Double Blind Phase: Change From Randomization in DAS28-4 (C-reactive Protein [CRP]) at Weeks 36 and 48

DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from SJC and TJC using 28 joints count, CRP (milligrams per liter [mg/L]) and PtGA on a 100 mm VAS (VAS: scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (CRP) <= 3.2 implied low disease activity and > 3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (CRP) < 2.6 implied remission. DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP in mg/L +1) + 0.014*PtGA in mm+ 0.96; ln = natural logarithm, sqrt = square root of.

Double Blind Phase: Change From Randomization in Clinical Disease Activity Index (CDAI) at Weeks 36 and 48

CDAI was calculated from tender and swollen joints using 28 joint count, PtGA and physician global assessment of arthritis (PhyGA). PtGA and PhyGA both were assessed on 0-10 centimeter (cm) VAS scale (VAS: scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <=10 indicated low disease activity and a score of <= 2.8 indicated remission. CDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm).

Double Blind Phase: Change From Randomization in Simplified Disease Activity Index (SDAI) at Weeks 36 and 48

SDAI was calculated from tender and swollen joints using 28 joint count, PtGA, PhyGA and CRP (in mg/dL). PtGA and PhyGA both were assessed on 0-10 cm VAS scale (VAS: scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of <=11 indicates low disease activity and a score of <=3.3 indicates remission. SDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm) + (CRP in mg/dL).

Double Blind Phase: Percentage of Participants With Low Disease Activity (LDA) Assessed by DAS28-4 (ESR) Less Than or Equal to (<=) 3.2 at Weeks 36 and 48

DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and PtGA on a 100 mm VAS (VAS: scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicated worse health condition). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (ESR) <=3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (ESR) <2.6 implied remission. DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*In(ESR in mm/hour) + 0.014*PtGA in mm; ln = natural logarithm, sqrt = square root of.

Double Blind Phase: Percentage of Participants With LDA Assessed by DAS28-4 (CRP) <=3.2 at Weeks 36 and 48

DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from SJC and TJC using 28 joints count, CRP (mg/L) and PtGA on a 100 mm VAS (VAS: scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (CRP) <=3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (CRP) <2.6 implied remission. DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP in mg/L +1) + 0.014*PtGA in mm+ 0.96; ln = natural logarithm, sqrt = square root of.

Double Blind Phase: Percentage of Participants With LDA Assessed by CDAI <=10 at Weeks 36 and 48

CDAI was calculated from tender and swollen joints using 28 joint count, PtGA and PhyGA. PtGA and PhyGA both were assessed on 0-10 cm VAS scale (VAS: scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <=10 indicated low disease activity and a score of <= 2.8 indicated remission. Percentage of participants with CDAI <=10 were reported. CDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm).

Double Blind Phase: Percentage of Participants With LDA Assessed by SDAI <=11 at Weeks 36 and 48

SDAI was calculated from tender and swollen joints using 28 joint count, PtGA, PhyGA and CRP (in mg/dL). PtGA and PhyGA both were assessed on 0-10 cm VAS scale (VAS: scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of <=11 indicated low disease activity and a score of <=3.3 indicated remission. SDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm) + (CRP in mg/dL).

Double Blind Phase: Percentage of Participants With Remission Assessed by American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean at Weeks 36 and 48

ACR-EULAR Boolean remission was when a participant satisfied all of the following: tender joint count, swollen joint count (both based on a 28-joint assessment), CRP (in mg/dL), and PtGA (VAS: 0 cm [very well] to 10 cm [worst], higher scores indicated worse health condition) and all scores were <=1.

Double Blind Phase: Percentage of Participants With Remission Assessed by DAS28-4 (ESR) Less Than [<] 2.6 at Weeks 36 and 48

DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and PtGA on a 100 mm VAS (VAS: scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicate worse health condition). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (ESR) <2.6 implied remission. DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*In(ESR in mm/hour) + 0.014*PtGA in mm. Percentage of participants with DAS remission (DAS28-4-ESR<2.6) were reported in this outcome measure.

Double Blind Phase: Percentage of Participants With Remission Assessed by DAS28-4 (CRP) <2.6 at Weeks 36 and 48

DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from SJC and TJC using 28 joints count, CRP (mg/L) and PtGA on a 100 mm VAS (VAS: scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (CRP) <=3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (CRP) <2.6 implied remission. DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP in mg/l +1) + 0.014*PtGA in mm+ 0.96. Percentage of participants with DAS remission (DAS28-4-CRP<2.6) were reported in this outcome measure.

Double Blind Phase: Percentage of Participants With Remission Assessed by CDAI <=2.8 at Weeks 36 and 48

CDAI was calculated from tender and swollen joints using 28 joint count, PtGA and PhyGA. PtGA and PhyGA both were assessed on 0-10 cm VAS scale (VAS: scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <=10 indicated low disease activity and a score of <= 2.8 indicated remission. CDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm).

Double Blind Phase: Percentage of Participants With Remission Assessed by SDAI <=3.3 at Weeks 36 and 48

Double Blind Phase: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response at Weeks 36 and 48

Participants with 20% improvement in tender and swollen joint counts and 20% improvement in at least 3 of the 5 measures: PtGA, PhyGA, participant's assessment of arthritis pain, Health Assessment Questionnaire-Disability Index (HAQ-DI) and CRP. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher scores = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher scores = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability. The improvement was relative to baseline (Day 1).

Double Blind Phase: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Weeks 36 and 48

Participants with 50% improvement in tender and swollen joint counts and 50% improvement in at least 3 of the 5 measures: PtGA, PhyGA, participant's assessment of arthritis pain, HAQ-DI and CRP. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher scores = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher scores = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability. The improvement was relative to baseline (Day 1).

Double Blind Phase: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response at Weeks 36 and 48

Participants with 70% improvement in tender and swollen joint counts and 70% improvement in at least 3 of the 5 measures: PtGA, PhyGA, participant's assessment of arthritis pain, HAQ-DI and CRP. PtGA: participant assessed health on VAS, 0 mm (very well) to 100 mm (worst health condition), higher scores = worse condition. PhyGA: physician judged participants' pain on VAS, 0 (no pain) to 100 mm (extreme pain), higher scores = more pain. Participant's assessment of arthritis pain: participant assessed pain on VAS, 0 mm (no pain) to 100 mm (most severe pain), higher score = more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability. The improvement was relative to baseline (Day 1).

Double Blind Phase: Change From Randomization in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Weeks 36 and 48

HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities.. There were total of 30 items distributed in these 8 domains. Each item was scored on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.

Double Blind Phase: Change From Randomization in the Short Form 36 (SF-36) Health Survey 8 Domain Scores at Weeks 36 and 48

SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: physical functioning, role physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health perception. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of 8 health aspects were summarized to derive the 2 component scores (physical component scores [PCS], mental component scores [MCS]) ranging from 0 (worst) to 100 (best), where higher PCS/MCS indicated good health condition.

Double Blind Phase: Change From Randomization in the SF-36 Health Survey Component Scores at Weeks 36 and 48

SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: physical functioning, role physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health perception. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of 8 health aspects were summarized aggregated to derive the two 2 component scores PCS and MCS ranging from 0 (worst) to 100 (best), where higher PCS/MCS indicated good health condition.

Double Blind Phase: Change From Randomization in the Work Productivity and Activity Impairment (WPAI) Scores at Week 36 and 48

WPAI is 6-question participant rated questionnaire to determine the impact of rheumatoid arthritis and yields 4 types of outcomes: absenteeism (work time missed), presenteeism (impairment while working), work productivity loss (overall work impairment), and daily activity impairment (activity impairment) for a period of 7 days prior to a visit. These 4 outcomes are expressed as an impairment percentage (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.

Double Blind Phase: Change From Randomization in the European Quality of Life - 5 Dimensions Questionnaire (EQ-5D) Scores at Weeks 36 and 48

EQ-5D was a participant completed instrument designed to assess impact on quality of life in terms of a single utility score in 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. 3 possible answers for mobility: 1=no problem in walking, 2=moderate problems in walking, 3= confined to bed; self-care: 1=no problem, 2=moderate problems, 3= unable to wash/dress; usual activities: 1=no problem, 2=moderate problems, 3= unable to do usual activities; pain and discomfort: 1=no pain or discomfort, 2=moderate pain or discomfort, 3= extreme pain or discomfort; anxiety and depression: 1=not anxious or depressed, 2=moderately anxious or depressed, 3= extremely anxious or depressed. The 5-dimensional systems are converted into a single index utility score between 0 and 1, where higher score indicated a better health state.

Double Blind Phase: Change From Randomization in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Scores at Weeks 36 and 48

The FACIT-Fatigue scale was a participant completed questionnaire consisted of 13 items that assessed fatigue. Each item was scored on a scale of 0 (maximum fatigue) to 4 (no fatigue), higher scores indicate less fatigue. Total FACIT-fatigue score was obtained by addition of scores from 13 items, giving a possible overall range from 0 (maximum fatigue) to 52 (no fatigue). Higher FACIT-fatigue scores indicated lower level of fatigue, better participant status.

Double Blind Phase: Percentage of Participants Achieving an Improvement of at Least 0.22 Units in HAQ-DI at Weeks 36 and 48

Full Information

NCT ID

NCT02831855

First Posted

July 11, 2016

Last Updated

November 13, 2019

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT02831855

Brief Title

Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis

Official Title

A PHASE 3B/4 RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED STUDY OF METHOTREXATE (MTX) WITHDRAWAL IN SUBJECTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH TOFACITINIB 11MG MODIFIED RELEASE (MR) FORMULATION

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

September 1, 2016 (Actual)

Primary Completion Date

November 19, 2018 (Actual)

Study Completion Date

December 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is designed to evaluate the efficacy and safety of tofacitinib modified release formulation (11mg QD) versus tofacitinib modified release formulation plus continued methotrexate treatment in subjects with moderate to severe rheumatoid arthritis who are insufficiently responding to their stable dose of methotrexate treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, Tofacitinib, CP-690,550, Xeljanz, methotrexate withdrawal, withdrawal study

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

694 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CP-690,550 and methotrexate

Arm Type

Experimental

Arm Description

Open-label tofacitinib tablet and blinded methotrexate capsule

Arm Title

CP-690,550 and placebo

Arm Type

Placebo Comparator

Arm Description

open-label tofacitinib tablet and blinded matching placebo for methotrexate capsule

Intervention Type

Drug

Intervention Name(s)

CP-690,550

Other Intervention Name(s)

tofacitinib

Intervention Description

During the open-label run-in phase (Day 1 to Week 24), all subjects will receive one tablet open-label tofacitinib MR 11mg orally QD and open-label methotrexate capsule(s) orally every week at prior stabilized dose. During the double-blind phase, subjects who are randomized to the treatment arm will receive the same dosage of tofacitinib and methotrexate as describe above.

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Intervention Description

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

During the double-blind phase, subjects who are randomized to the comparison arm will receive 11mg QD tofacitinib and the placebo capsules matching for methotrexate.

Primary Outcome Measure Information:

Title

Double Blind Phase: Change From Randomization in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (Erythrocyte Sedimentation Rate [ESR]) at Week 48

Description

Time Frame

Randomization (last non-missing measurement on or prior to the first dosing date in DB phase at Week 24), Week 48

Secondary Outcome Measure Information:

Title

Double Blind Phase: Change From Randomization in DAS28-4 ESR at Week 36

Description

Time Frame

Randomization (last non-missing measurement on or prior to the first dosing date in DB phase at Week 24), Week 36

Title

Double Blind Phase: Change From Randomization in DAS28-4 (C-reactive Protein [CRP]) at Weeks 36 and 48

Description

Time Frame

Randomization (last non-missing measurement on or prior to the first dosing date in DB phase at Week 24), Weeks 36 and 48

Title

Double Blind Phase: Change From Randomization in Clinical Disease Activity Index (CDAI) at Weeks 36 and 48

Description

Time Frame

Randomization (last non-missing measurement on or prior to the first dosing date in DB phase at Week 24), Weeks 36 and 48

Title

Double Blind Phase: Change From Randomization in Simplified Disease Activity Index (SDAI) at Weeks 36 and 48

Description

Time Frame

Randomization (last non-missing measurement on or prior to the first dosing date in DB phase at Week 24), Weeks 36 and 48

Title

Double Blind Phase: Percentage of Participants With Low Disease Activity (LDA) Assessed by DAS28-4 (ESR) Less Than or Equal to (<=) 3.2 at Weeks 36 and 48

Description

DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and PtGA on a 100 mm VAS (VAS: scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicated worse health condition). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (ESR) <=3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (ESR) <2.6 implied remission. DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*In(ESR in mm/hour) + 0.014*PtGA in mm; ln = natural logarithm, sqrt = square root of.

Time Frame

Weeks 36 and 48

Title

Double Blind Phase: Percentage of Participants With LDA Assessed by DAS28-4 (CRP) <=3.2 at Weeks 36 and 48

Description

Time Frame

Weeks 36 and 48

Title

Double Blind Phase: Percentage of Participants With LDA Assessed by CDAI <=10 at Weeks 36 and 48

Description

Time Frame

Weeks 36 and 48

Title

Double Blind Phase: Percentage of Participants With LDA Assessed by SDAI <=11 at Weeks 36 and 48

Description

SDAI was calculated from tender and swollen joints using 28 joint count, PtGA, PhyGA and CRP (in mg/dL). PtGA and PhyGA both were assessed on 0-10 cm VAS scale (VAS: scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). SDAI total score ranged from 0 to 86, where higher scores indicated higher disease activity. SDAI score of <=11 indicated low disease activity and a score of <=3.3 indicated remission. SDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm) + (CRP in mg/dL).

Time Frame

Weeks 36 and 48

Title

Double Blind Phase: Percentage of Participants With Remission Assessed by American College of Rheumatology-European League Against Rheumatism (ACR-EULAR) Boolean at Weeks 36 and 48

Description

Time Frame

Weeks 36 and 48

Title

Double Blind Phase: Percentage of Participants With Remission Assessed by DAS28-4 (ESR) Less Than [<] 2.6 at Weeks 36 and 48

Description

DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and PtGA on a 100 mm VAS (VAS: scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicate worse health condition). Total DAS28-4 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (ESR) <2.6 implied remission. DAS28-4 (ESR) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.70*In(ESR in mm/hour) + 0.014*PtGA in mm. Percentage of participants with DAS remission (DAS28-4-ESR<2.6) were reported in this outcome measure.

Time Frame

Weeks 36 and 48

Title

Double Blind Phase: Percentage of Participants With Remission Assessed by DAS28-4 (CRP) <2.6 at Weeks 36 and 48

Description

DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from SJC and TJC using 28 joints count, CRP (mg/L) and PtGA on a 100 mm VAS (VAS: scores ranging from 0 mm [very well] to 100 mm [worst], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (CRP) <=3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (CRP) <2.6 implied remission. DAS28-4 (CRP) = 0.56*sqrt(TJC28) + 0.28*sqrt(SJC28) + 0.36*ln(CRP in mg/l +1) + 0.014*PtGA in mm+ 0.96. Percentage of participants with DAS remission (DAS28-4-CRP<2.6) were reported in this outcome measure.

Time Frame

Weeks 36 and 48

Title

Double Blind Phase: Percentage of Participants With Remission Assessed by CDAI <=2.8 at Weeks 36 and 48

Description

CDAI was calculated from tender and swollen joints using 28 joint count, PtGA and PhyGA. PtGA and PhyGA both were assessed on 0-10 cm VAS scale (VAS: scores ranging from 0 cm [very well] to 10 cm [worst]), where higher scores indicated greater affliction due to disease activity). CDAI total score ranged from 0 to 76, where higher scores indicated higher disease activity. CDAI score of <=10 indicated low disease activity and a score of <= 2.8 indicated remission. CDAI = (28TJC) + (28SJC) + (PhyGA in cm) + (PtGA in cm).

Time Frame

Weeks 36 and 48

Title

Double Blind Phase: Percentage of Participants With Remission Assessed by SDAI <=3.3 at Weeks 36 and 48

Description

Time Frame

Weeks 36 and 48

Title

Double Blind Phase: Percentage of Participants Achieving an American College of Rheumatology 20 Percent (%) (ACR20) Response at Weeks 36 and 48

Description

Time Frame

Baseline (Day 1), Weeks 36 and 48

Title

Double Blind Phase: Percentage of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Weeks 36 and 48

Description

Time Frame

Baseline (Day 1), Weeks 36 and 48

Title

Double Blind Phase: Percentage of Participants Achieving an American College of Rheumatology 70% (ACR70) Response at Weeks 36 and 48

Description

Time Frame

Baseline (Day 1), Weeks 36 and 48

Title

Double Blind Phase: Change From Randomization in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Weeks 36 and 48

Description

Time Frame

Randomization (last non-missing measurement on or prior to the first dosing date in DB phase at Week 24), Weeks 36 and 48

Title

Double Blind Phase: Change From Randomization in the Short Form 36 (SF-36) Health Survey 8 Domain Scores at Weeks 36 and 48

Description

Time Frame

Randomization (last non-missing measurement on or prior to the first dosing date in DB phase at Week 24), Weeks 36 and 48

Title

Double Blind Phase: Change From Randomization in the SF-36 Health Survey Component Scores at Weeks 36 and 48

Description

SF-36 is a participant reported standardized survey designed to assess generic health related quality of life. It consisted of 36 items evaluating 8 aspects of functional health and well-being: physical functioning, role physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health perception. The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition. Scores of 8 health aspects were summarized aggregated to derive the two 2 component scores PCS and MCS ranging from 0 (worst) to 100 (best), where higher PCS/MCS indicated good health condition.

Time Frame

Randomization (last non-missing measurement on or prior to the first dosing date in DB phase at Week 24), Weeks 36 and 48

Title

Double Blind Phase: Change From Randomization in the Work Productivity and Activity Impairment (WPAI) Scores at Week 36 and 48

Description

Time Frame

Randomization (last non-missing measurement on or prior to the first dosing date in DB phase at Week 24), Week 36 and 48

Title

Double Blind Phase: Change From Randomization in the European Quality of Life - 5 Dimensions Questionnaire (EQ-5D) Scores at Weeks 36 and 48

Description

Time Frame

Randomization (last non-missing measurement on or prior to the first dosing date in DB phase at Week 24), Weeks 36 and 48

Title

Double Blind Phase: Change From Randomization in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Scores at Weeks 36 and 48

Description

Time Frame

Randomization (last non-missing measurement on or prior to the first dosing date in DB phase at Week 24), Weeks 36 and 48

Title

Double Blind Phase: Percentage of Participants Achieving an Improvement of at Least 0.22 Units in HAQ-DI at Weeks 36 and 48

Description

Time Frame

Baseline (Day 1), Weeks 36 and 48

Other Pre-specified Outcome Measures:

Title

Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious AEs

Description

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 52 (up to 28 days after last dose) that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.

Time Frame

For OL Phase: Baseline up to Week 24; For DB Phase: Week 24 up to Week 52 (up to 28 days after last dose)

Title

Number of Participants With Abnormal Laboratory Parameters

Description

Abnormality criteria: Hemoglobin (Hb),Hematocrit,Erythrocytes(Ery): <0.8*LLN;Ery. Mean corpuscular volume <0.9*lower limit of normal (LLN), >1.1*upper limit of normal (ULN); Platelets:<0.5*LLN,>1.75*ULN;WBCs:<0.6*LLN,>1.5*ULN; Lymphocytes/WBCs, Neutrophils/WBCs:<0.8*LLN,>1.2* ULN;Basophils,Basophils/WBCs,Eosinophils,Eosinophils/WBCs,Monocytes, Monocytes/WBCs: >1.2*ULN;Prothrombin Time, Prothrombin Intl. Normalized Ratio:>1.1*ULN; ESR:>1.5*ULN; Bilirubin,Direct Bilirubin,Indirect Bilirubin: >1.5*ULN; Aspartate Aminotransferase (AT),Alanine AT,Gamma Glutamyl Transferase,Alkaline Phosphatase:>3.0*ULN; Protein, Albumin: <0.8*LLN, >1.2x ULN; Blood Urea Nitrogen, Creatinine, Triglycerides: >1.3*ULN;HDL Cholesterol:<0.8*LLN;Sodium <0.95*LLN, >1.05*ULN;Potassium, Chloride, Calcium, Bicarbonate: <0.9*LLN, >1.1*ULN; Glucose: <0.6*LLN, >1.5*ULN; Creatine Kinase: >2.0*ULN; Cholesterol:>1.3*ULN;Specific Gravity:<1.003;pH:<4.5; urine glucose,Ketones,urine protein,urine Hb,WBCs Esterase: >=1.

Time Frame

For OL Phase: Baseline up to Week 24; For DB Phase: Week 24 up to Week 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria - Must be 18 years of age or older. Have a score of 6 or greater on the 2010 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Rheumatoid Arthritis at and/or prior to Screening Visit. Have ≥4 tender/painful joints on motion and ≥4 swollen joints (28 joint counts) at both Screening Visit and Baseline Visit (Visit 1). Have moderate to severe disease activity as defined by CDAI>10 and DAS28-4(ESR) ≥3.2 at Baseline Visit. Have taken an oral MTX treatment regimen (15-25mg/week) continuously for at least 4 months prior to the screening visit and has taken a stable weekly dose of oral MTX with supplemental folic acid or folinic acid for at least 4 weeks prior to the baseline visit (conversion from parenteral MTX to oral MTX will require stabilization of the treatment regimen for at least 1 month). Subjects must screen negative for active tuberculosis or inadequately treated tuberculosis infection (active or latent). Key Exclusion Criteria Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children and female subjects of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 3 months after the last dose of investigational product. Subjects with infection or infection history; subjects with any current malignancy or a history of malignancy (except adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ); subjects with history of, or current evidence for, severe gastrointestinal narrowing (pathologic or iatrogenic); and subjects with history of documented diverticulitis. Subjects with a history of insufficient response to ≥2 biologics, regardless of the class.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

Rheumatology Associates of North Alabama, PC

City

Huntsville

State/Province

Alabama

ZIP/Postal Code

35801-4418

Country

United States

Facility Name

Arthrocare, Arthritiscare & Research, PC

City

Gilbert

State/Province

Arizona

ZIP/Postal Code

85234

Country

United States

Facility Name

SunValley Arthritis Center, Ltd.

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

CHI St. Vincent Medical Group Hot Springs

City

Hot Springs

State/Province

Arkansas

ZIP/Postal Code

71913

Country

United States

Facility Name

Med Investigations, Inc

City

Fair Oaks

State/Province

California

ZIP/Postal Code

95628

Country

United States

Facility Name

HCP Clinical Research, LLC

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92646

Country

United States

Facility Name

Sierra Rheumatology

City

Roseville

State/Province

California

ZIP/Postal Code

95661

Country

United States

Facility Name

Pacific Arthritis Center Medical Group

City

Santa Maria

State/Province

California

ZIP/Postal Code

93454

Country

United States

Facility Name

Robin K. Dore, MD, Inc.

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

Inland Rheumatology and Osteoporosis Medical Group

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Inland Rheumatology Clinical Trials, Inc.

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Desert Valley Medical Group

City

Victorville

State/Province

California

ZIP/Postal Code

92395

Country

United States

Facility Name

AARDS Research Inc

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

RASF-Clinical Research Inc

City

Boca Raton

State/Province

Florida

ZIP/Postal Code

33486

Country

United States

Facility Name

Omega Research Consultants

City

DeBary

State/Province

Florida

ZIP/Postal Code

32713

Country

United States

Facility Name

University of Florida College of Medicine - Jacksonville - Rheumatology Research

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32207

Country

United States

Facility Name

University of Florida, Rheumatology at ACC

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32209

Country

United States

Facility Name

Center for Arthritis and Rheumatic Diseases

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

Facility Name

Jeffrey Alper, MD

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Medallion Clinical Research Institute, LLC

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Suncoast Clinical Research, Inc.

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

Florida Arthritis & Osteoporosis Center

City

Port Richey

State/Province

Florida

ZIP/Postal Code

34668

Country

United States

Facility Name

Gulf Coast Medical Center

City

Port Richey

State/Province

Florida

ZIP/Postal Code

34668

Country

United States

Facility Name

West Broward Rheumatology Associates, Inc.

City

Tamarac

State/Province

Florida

ZIP/Postal Code

33321

Country

United States

Facility Name

USF Health Morsani Center for Advanced Healthcare

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

BayCare Medical Group, Inc

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

Institute of Arthritis Research

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

Quincy Medical Group

City

Quincy

State/Province

Illinois

ZIP/Postal Code

62301

Country

United States

Facility Name

Beacon Medical Group Rheumatology Main Street

City

Granger

State/Province

Indiana

ZIP/Postal Code

46530

Country

United States

Facility Name

Diagnostic Rheumatology and Research, PC

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46227

Country

United States

Facility Name

Ochsner Clinic Baton Rouge

City

Baton Rouge

State/Province

Louisiana

ZIP/Postal Code

70836

Country

United States

Facility Name

Phase III Clinical Research

City

Fall River

State/Province

Massachusetts

ZIP/Postal Code

02720

Country

United States

Facility Name

Clinical Pharmacology Study Group

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

Country

United States

Facility Name

Bronson Internal Medicine and Rheumatology

City

Battle Creek

State/Province

Michigan

ZIP/Postal Code

49015

Country

United States

Facility Name

Western Michigan University Homer Stryker MD

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49007

Country

United States

Facility Name

North Mississippi Medical Clinics, Inc. - Clinical Research

City

Tupelo

State/Province

Mississippi

ZIP/Postal Code

38801

Country

United States

Facility Name

Arthritis & Osteoporosis Associates

City

Freehold

State/Province

New Jersey

ZIP/Postal Code

07728

Country

United States

Facility Name

Radnet

City

Marlton

State/Province

New Jersey

ZIP/Postal Code

08053

Country

United States

Facility Name

Arthritis, Rheumatic & Back Disease Associates, P.A.

City

Voorhees

State/Province

New Jersey

ZIP/Postal Code

08043

Country

United States

Facility Name

Open MRI & Diagnostic Imaging of Wall

City

Wall

State/Province

New Jersey

ZIP/Postal Code

07719

Country

United States

Facility Name

AAIR Research Center

City

Rochester

State/Province

New York

ZIP/Postal Code

14618

Country

United States

Facility Name

Physicians East, PA

City

Greenville

State/Province

North Carolina

ZIP/Postal Code

27834

Country

United States

Facility Name

PMG Research of Salisbury

City

Salisbury

State/Province

North Carolina

ZIP/Postal Code

28144

Country

United States

Facility Name

Trinity Health Center-Medical Arts

City

Minot

State/Province

North Dakota

ZIP/Postal Code

58701

Country

United States

Facility Name

Group Health Associates

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45236

Country

United States

Facility Name

Cincinnati Rheumatic Disease Study Group, Inc.

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

STAT Research, Inc.

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45417

Country

United States

Facility Name

Health Research of Oklahoma

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Oklahoma Medical Research Foundation (OMRF)

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73104

Country

United States

Facility Name

Lynn Health Science Institute

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73112

Country

United States

Facility Name

East Penn Rheumatology Associates, P.C.

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18015

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Piedmont Arthritis Clinic

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29601

Country

United States

Facility Name

Articularis Healthcare Group dba ACME Research

City

Orangeburg

State/Province

South Carolina

ZIP/Postal Code

29118

Country

United States

Facility Name

Articularis Healthcare Group d/b/a Low Country Rheumatology

City

Summerville

State/Province

South Carolina

ZIP/Postal Code

29486

Country

United States

Facility Name

Pioneer Research Solutions, Inc.

City

Cypress

State/Province

Texas

ZIP/Postal Code

77429

Country

United States

Facility Name

Metroplex Clinical Research Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Center for Arthritis and Rheumatic Diseases

City

Chesapeake

State/Province

Virginia

ZIP/Postal Code

23320

Country

United States

Facility Name

Center for Arthritis and Rheumatic Diseases

City

Suffolk

State/Province

Virginia

ZIP/Postal Code

23435

Country

United States

Facility Name

Genesis Research Services Pty Ltd

City

Broadmeadow

State/Province

New South Wales

ZIP/Postal Code

2292

Country

Australia

Facility Name

Optimus Clinical Research Pty Ltd

City

Kogarah

State/Province

New South Wales

ZIP/Postal Code

2217

Country

Australia

Facility Name

Rheumatology Research Unit

City

Maroochydore

State/Province

Queensland

ZIP/Postal Code

4558

Country

Australia

Facility Name

Emeritus Research

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3124

Country

Australia

Facility Name

ReumaClinic

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

AZ Delta

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

University Multiprofile Hospital for Active Treatment Dr. G. Stranski EAD

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Multiprofile Hospital for Active Treatment - Plovdiv AD, Rheumatology Department

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Multiprofile Hospital for Active Treatment Trimontium OOD

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

University Multiprofile Hospital for Active Treatment - Kaspela EOOD

City

Plovdiv

ZIP/Postal Code

4001

Country

Bulgaria

Facility Name

National Multiprofile Transport Hospital Tsar Boris III

City

Sofia

ZIP/Postal Code

1233

Country

Bulgaria

Facility Name

Medical Centre Synexus Sofia EOOD

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

CCBR Czech Brno, s.r.o.

City

Brno

State/Province

Czech Republic

ZIP/Postal Code

602 00

Country

Czechia

Facility Name

LEKARNA LANCIER s.r.o.

City

Brno

ZIP/Postal Code

602 00

Country

Czechia

Facility Name

Lekarna Na Lidicke

City

Brno

ZIP/Postal Code

602 00

Country

Czechia

Facility Name

Revmacentrum MUDr. Mostera, s.r.o., Revmatologie a interna

City

Brno

ZIP/Postal Code

615 00

Country

Czechia

Facility Name

CCBR Ostrava, s.r.o.

City

Ostrava

ZIP/Postal Code

702 00

Country

Czechia

Facility Name

Lekarna Rezidence Nova Karolina

City

Ostrava

ZIP/Postal Code

702 00

Country

Czechia

Facility Name

Revmatologicky ustav, Lekrna

City

Praha 2

ZIP/Postal Code

128 50

Country

Czechia

Facility Name

Revmatologicky ustav

City

Praha 2

ZIP/Postal Code

128 50

Country

Czechia

Facility Name

Lekarna Hradebni s.r.o.

City

Uherske Hradiste

ZIP/Postal Code

686 01

Country

Czechia

Facility Name

MEDICAL PLUS, s.r.o. Revmatologicka a osteologicka ambulance

City

Uherske Hradiste

ZIP/Postal Code

686 01

Country

Czechia

Facility Name

PV - MEDICAL s.r.o., Revmatologicka ambulance

City

Zlin

ZIP/Postal Code

760 01

Country

Czechia

Facility Name

Revmavita s.r.o, Lekarna

City

Zlin

ZIP/Postal Code

760 01

Country

Czechia

Facility Name

Hamburger Rheuma Forschungszentrum I

City

Hamburg

ZIP/Postal Code

22391

Country

Germany

Facility Name

DRC Gyogyszervizsgalo Kozpont Kft.

City

Balatonfured

ZIP/Postal Code

8230

Country

Hungary

Facility Name

Revita Rendelo

City

Budapest

ZIP/Postal Code

1027

Country

Hungary

Facility Name

Qualiclinic Kft.

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

CRU Hungary Kft.

City

Miskolc

ZIP/Postal Code

3529

Country

Hungary

Facility Name

Clinical Trial Pharmacy, KyungHee University Hospital

City

Seoul

ZIP/Postal Code

02447

Country

Korea, Republic of

Facility Name

KyungHee University Hospital

City

Seoul

ZIP/Postal Code

02447

Country

Korea, Republic of

Facility Name

CTC Pharmacy, Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Konkuk University Medical Center

City

Seoul

ZIP/Postal Code

05030

Country

Korea, Republic of

Facility Name

Clinical Trial Pharmacy, The Catholic University of Korea, Seoul St. Mary's Hospital

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

The Catholic University of Korea Seoul, St. Mary's Hospital

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

Centro de Investigacion y Tratamiento Reumatologico SC Consultorio Medico de Reumatologia (CINTRE)

City

Mexico

State/Province

Ciudad DE Mexico

ZIP/Postal Code

11850

Country

Mexico

Facility Name

Morales Vargas Centro de Investigacion SC (Consultorio Anexo)

City

Leon

State/Province

Guanajuato

ZIP/Postal Code

37000

Country

Mexico

Facility Name

Mary Mediatrix Medical Center

City

Lipa City

State/Province

Batangas

ZIP/Postal Code

4217

Country

Philippines

Facility Name

Far Eastern University - Nicanor Reyes Medical Foundation, Marian Medical Arts Bldg

City

Quezon City

State/Province

Metro Manila

ZIP/Postal Code

1118

Country

Philippines

Facility Name

Zdrowie OSTEO-MEDIC s.c. L i A. Racewicz, A i J. Supronik

City

Bialystok

ZIP/Postal Code

15-351

Country

Poland

Facility Name

ClinicMed Daniluk, Nowak. Sp. j.

City

Bialystok

ZIP/Postal Code

15-879

Country

Poland

Facility Name

Nzoz Bif - Med

City

Bytom

ZIP/Postal Code

41-902

Country

Poland

Facility Name

Centrum Medyczne Pratia Krakow

City

Krakow

ZIP/Postal Code

30-002

Country

Poland

Facility Name

Malopolskie Centrum Medyczne S.C.

City

Krakow

ZIP/Postal Code

30-510

Country

Poland

Facility Name

NZOZ Lecznica MAK-MED. S.C.

City

Nadarzyn

ZIP/Postal Code

05-830

Country

Poland

Facility Name

MTZ Clinical Research Sp. z o.o.

City

Warszawa

ZIP/Postal Code

02-106

Country

Poland

Facility Name

Federal State Budgetary Scientific Institution "Research Institute of Rheumatology

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

FSBEI HE "Orenburg State Medical University" of MoH RF

City

Orenburg

ZIP/Postal Code

460000

Country

Russian Federation

Facility Name

FSBEI HE "Orenburg State Medical University" of MoH RF

City

Orenburg

ZIP/Postal Code

460018

Country

Russian Federation

Facility Name

SPb SBIH "Consultative-Diagnostic Centre #85"

City

Saint Petersburg

ZIP/Postal Code

198260

Country

Russian Federation

Facility Name

FSBIH "Clinical Hospital #122 n.a. L.G. Sokolov" of FMBA of Russia

City

Saint-Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

SBIH "Samara Regional Clinical Hospital n.a. V.D. Seredavin"

City

Samara

ZIP/Postal Code

443095

Country

Russian Federation

Facility Name

NSHI "Departmental Hospital at Smolensk station OJSC "Russian Railways"

City

Smolensk

ZIP/Postal Code

214025

Country

Russian Federation

Facility Name

SAHI YR Clinical Hospital of Emergency Medical Care n.a. N.V. Soloviev

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

State Budgetary Institution of Healthcare of Yaroslavl Region "Regional Clinical Hospital"

City

Yaroslavl

ZIP/Postal Code

150062

Country

Russian Federation

Facility Name

AAGS s.r.o.

City

Dunajska Streda

ZIP/Postal Code

929 01

Country

Slovakia

Facility Name

MEDMAN s.r.o.

City

Martin

ZIP/Postal Code

03601

Country

Slovakia

Facility Name

REUMACENTRUM s.r.o.

City

Partizanske

ZIP/Postal Code

958 01

Country

Slovakia

Facility Name

MUDr. Zuzana Cizmarikova, s.r.o.

City

Poprad

ZIP/Postal Code

05801

Country

Slovakia

Facility Name

Reumex s.r.o

City

Rimavska Sobota

ZIP/Postal Code

979 01

Country

Slovakia

Facility Name

St. Augustine's Hospital

City

Durban

State/Province

Kwazulu Natal

ZIP/Postal Code

4001

Country

South Africa

Facility Name

Complejo Hospitalario Universitario de Santiago

City

Santiago de Compostela

State/Province

A Coruna

ZIP/Postal Code

15706

Country

Spain

Facility Name

Hospital Universitario de Cruces

City

Baracaldo

State/Province

Vizcaya

ZIP/Postal Code

48903

Country

Spain

Facility Name

Hospital Infanta Luisa

City

Sevilla

ZIP/Postal Code

41010

Country

Spain

Facility Name

Countess of Chester Hospital NHS Foundation Trust

City

Chester

State/Province

Cheshire

ZIP/Postal Code

CH2 1UL

Country

United Kingdom

Facility Name

Pharmacy (dispensary)

City

Chester

State/Province

Cheshire

ZIP/Postal Code

CH2 1UL

Country

United Kingdom

Facility Name

Countess of Chester Hospital NHS Foundation Trust

City

Ellesmere Port

State/Province

Cheshire

ZIP/Postal Code

CH65 6SG

Country

United Kingdom

Facility Name

Hampshire Hospitals NHS Foundation Trust

City

Basingstoke

State/Province

Hampshire

ZIP/Postal Code

RG24 9NA

Country

United Kingdom

Facility Name

Pharmacy, Hampshire Hospitals NHS Foundation Trust

City

Basingstoke

State/Province

Hampshire

ZIP/Postal Code

RG24 9NA

Country

United Kingdom

Facility Name

Department of Rheumatology, Wirral University Teaching Hospital NHS Foundation Trust

City

Wirral

State/Province

Merseyside

ZIP/Postal Code

CH49 5PE

Country

United Kingdom

Facility Name

Pharmacy Department, Wirral University Teaching Hospital NHS Foundation Trust

City

Wirral

State/Province

Merseyside

ZIP/Postal Code

CH49 5PE

Country

United Kingdom

Facility Name

Wirral University Teaching Hospital NHS Foundation Trust

City

Wirral

State/Province

Merseyside

ZIP/Postal Code

CH49 5PE

Country

United Kingdom

Facility Name

Pharmacy Department

City

Dudley

State/Province

WEST Midlands

ZIP/Postal Code

DY1 2HQ

Country

United Kingdom

Facility Name

The Dudley Group NHS Foundation Trust

City

Dudley

State/Province

WEST Midlands

ZIP/Postal Code

DY1 2HQ

Country

United Kingdom

Facility Name

Pharmacy

City

Manchester

ZIP/Postal Code

M23 9LT

Country

United Kingdom

Facility Name

University Hospital of South Manchester NHS Foundation Trust

City

Manchester

ZIP/Postal Code

M23 9LT

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing URL

https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

Citations:

PubMed Identifier

18183025

Citation

Karaman MW, Herrgard S, Treiber DK, Gallant P, Atteridge CE, Campbell BT, Chan KW, Ciceri P, Davis MI, Edeen PT, Faraoni R, Floyd M, Hunt JP, Lockhart DJ, Milanov ZV, Morrison MJ, Pallares G, Patel HK, Pritchard S, Wodicka LM, Zarrinkar PP. A quantitative analysis of kinase inhibitor selectivity. Nat Biotechnol. 2008 Jan;26(1):127-32. doi: 10.1038/nbt1358.

Results Reference

background

PubMed Identifier

20701804

Citation

Meyer DM, Jesson MI, Li X, Elrick MM, Funckes-Shippy CL, Warner JD, Gross CJ, Dowty ME, Ramaiah SK, Hirsch JL, Saabye MJ, Barks JL, Kishore N, Morris DL. Anti-inflammatory activity and neutrophil reductions mediated by the JAK1/JAK3 inhibitor, CP-690,550, in rat adjuvant-induced arthritis. J Inflamm (Lond). 2010 Aug 11;7:41. doi: 10.1186/1476-9255-7-41.

Results Reference

background

PubMed Identifier

17312100

Citation

Murray PJ. The JAK-STAT signaling pathway: input and output integration. J Immunol. 2007 Mar 1;178(5):2623-9. doi: 10.4049/jimmunol.178.5.2623.

Results Reference

background

PubMed Identifier

17208301

Citation

O'Sullivan LA, Liongue C, Lewis RS, Stephenson SE, Ward AC. Cytokine receptor signaling through the Jak-Stat-Socs pathway in disease. Mol Immunol. 2007 Apr;44(10):2497-506. doi: 10.1016/j.molimm.2006.11.025. Epub 2007 Jan 17.

Results Reference

background

PubMed Identifier

21952978

Citation

Fleischmann R, Cutolo M, Genovese MC, Lee EB, Kanik KS, Sadis S, Connell CA, Gruben D, Krishnaswami S, Wallenstein G, Wilkinson BE, Zwillich SH. Phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) or adalimumab monotherapy versus placebo in patients with active rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs. Arthritis Rheum. 2012 Mar;64(3):617-29. doi: 10.1002/art.33383.

Results Reference

background

PubMed Identifier

22873530

Citation

Fleischmann R, Kremer J, Cush J, Schulze-Koops H, Connell CA, Bradley JD, Gruben D, Wallenstein GV, Zwillich SH, Kanik KS; ORAL Solo Investigators. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med. 2012 Aug 9;367(6):495-507. doi: 10.1056/NEJMoa1109071.

Results Reference

background

PubMed Identifier

22006202

Citation

Kremer JM, Cohen S, Wilkinson BE, Connell CA, French JL, Gomez-Reino J, Gruben D, Kanik KS, Krishnaswami S, Pascual-Ramos V, Wallenstein G, Zwillich SH. A phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) versus placebo in combination with background methotrexate in patients with active rheumatoid arthritis and an inadequate response to methotrexate alone. Arthritis Rheum. 2012 Apr;64(4):970-81. doi: 10.1002/art.33419. Epub 2011 Oct 17.

Results Reference

background

PubMed Identifier

24026258

Citation

Kremer J, Li ZG, Hall S, Fleischmann R, Genovese M, Martin-Mola E, Isaacs JD, Gruben D, Wallenstein G, Krishnaswami S, Zwillich SH, Koncz T, Riese R, Bradley J. Tofacitinib in combination with nonbiologic disease-modifying antirheumatic drugs in patients with active rheumatoid arthritis: a randomized trial. Ann Intern Med. 2013 Aug 20;159(4):253-61. doi: 10.7326/0003-4819-159-4-201308200-00006.

Results Reference

background

PubMed Identifier

23706795

Citation

Burmester GR, Benda B, Gruben D, Bradley J, Mebus C. Tofacitinib for rheumatoid arthritis - Authors' reply. Lancet. 2013 May 25;381(9880):1812-3. doi: 10.1016/S0140-6736(13)61115-0. No abstract available.

Results Reference

background

PubMed Identifier

22873531

Citation

van Vollenhoven RF, Fleischmann R, Cohen S, Lee EB, Garcia Meijide JA, Wagner S, Forejtova S, Zwillich SH, Gruben D, Koncz T, Wallenstein GV, Krishnaswami S, Bradley JD, Wilkinson B; ORAL Standard Investigators. Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med. 2012 Aug 9;367(6):508-19. doi: 10.1056/NEJMoa1112072. Erratum In: N Engl J Med. 2013 Jul 18;369(3):293.

Results Reference

background

PubMed Identifier

21294106

Citation

Felson DT, Smolen JS, Wells G, Zhang B, van Tuyl LH, Funovits J, Aletaha D, Allaart CF, Bathon J, Bombardieri S, Brooks P, Brown A, Matucci-Cerinic M, Choi H, Combe B, de Wit M, Dougados M, Emery P, Furst D, Gomez-Reino J, Hawker G, Keystone E, Khanna D, Kirwan J, Kvien TK, Landewe R, Listing J, Michaud K, Martin-Mola E, Montie P, Pincus T, Richards P, Siegel JN, Simon LS, Sokka T, Strand V, Tugwell P, Tyndall A, van der Heijde D, Verstappen S, White B, Wolfe F, Zink A, Boers M; American College of Rheumatology; European League Against Rheumatism. American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials. Arthritis Rheum. 2011 Mar;63(3):573-86. doi: 10.1002/art.30129.

Results Reference

background

PubMed Identifier

7175852

Citation

Fries JF, Spitz PW, Young DY. The dimensions of health outcomes: the health assessment questionnaire, disability and pain scales. J Rheumatol. 1982 Sep-Oct;9(5):789-93. No abstract available.

Results Reference

background

Citation

Ware JE KM, Dewey JE. . How to score Version 2 of the SF 36 Health Survey (Standard & Acute forms). In: How to score Version 2 of the SF 36 Health Survey (Standard & Acute forms). Lincoln, Rhode Island: QualityMetric, Incorporated. 2000.

Results Reference

background

PubMed Identifier

9189057

Citation

Hurst NP, Kind P, Ruta D, Hunter M, Stubbings A. Measuring health-related quality of life in rheumatoid arthritis: validity, responsiveness and reliability of EuroQol (EQ-5D). Br J Rheumatol. 1997 May;36(5):551-9. doi: 10.1093/rheumatology/36.5.551.

Results Reference

background

PubMed Identifier

10146874

Citation

Reilly MC, Zbrozek AS, Dukes EM. The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics. 1993 Nov;4(5):353-65. doi: 10.2165/00019053-199304050-00006.

Results Reference

background

PubMed Identifier

11900238

Citation

Cella D, Lai JS, Chang CH, Peterman A, Slavin M. Fatigue in cancer patients compared with fatigue in the general United States population. Cancer. 2002 Jan 15;94(2):528-38. doi: 10.1002/cncr.10245.

Results Reference

background

PubMed Identifier

35667900

Citation

Cohen SB, Haraoui B, Curtis JR, Smith TW, Woolcott J, Gruben D, Murray CW. Impact of Methotrexate Discontinuation, Interruption, or Persistence in US Patients with Rheumatoid Arthritis Initiating Tofacitinib + Oral Methotrexate Combination. Clin Ther. 2022 Jul;44(7):982-997.e2. doi: 10.1016/j.clinthera.2022.05.002. Epub 2022 Jun 4.

Results Reference

derived

PubMed Identifier

34103405

Citation

Cohen SB, Pope J, Haraoui B, Mysler E, Diehl A, Lukic T, Liu S, Stockert L, Germino R, Menon S, Shi H, Keystone EC. Efficacy and safety of tofacitinib modified-release 11 mg once daily plus methotrexate in adult patients with rheumatoid arthritis: 24-week open-label phase results from a phase 3b/4 methotrexate withdrawal non-inferiority study (ORAL Shift). RMD Open. 2021 Jun;7(2):e001673. doi: 10.1136/rmdopen-2021-001673.

Results Reference

derived

Links:

URL

https://pmiform.com/clinical-trial-info-request?StudyID=A3921192

Description

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Learn more about this trial

Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis

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