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Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

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

NCT02831855•Pfizer

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).

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.

Locations (136)

Rheumatology Associates of North Alabama, PC

Huntsville, Alabama, United States

Arthrocare, Arthritiscare & Research, PC

Gilbert, Arizona, United States

SunValley Arthritis Center, Ltd.

Peoria, Arizona, United States

CHI St. Vincent Medical Group Hot Springs

Hot Springs, Arkansas, United States

Med Investigations, Inc

Fair Oaks, California, United States

HCP Clinical Research, LLC

Huntington Beach, California, United States

Sierra Rheumatology

Roseville, California, United States

Pacific Arthritis Center Medical Group

Santa Maria, California, United States

Robin K. Dore, MD, Inc.

Tustin, California, United States

Inland Rheumatology and Osteoporosis Medical Group

Upland, California, United States

Key Dates

Start Date

September 1, 2016

Primary Completion Date

November 19, 2018

Completion Date

December 17, 2018

Last Updated

December 4, 2019

Enrollment

694

ACTUAL participants

Conditions

Rheumatoid Arthritis

Interventions

CP-690,550

DRUG

Methotrexate

DRUG

Placebo

DRUG

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Rheumatoid Arthritis (RA)Rheumatoid Arthritis-Associated Interstitial Lung Disease+1 more

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A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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