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Clinical Trial Details

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 (A3921192)
Study Purpose
To compare the efficacy of tofacitinib MR 11mg monotherapy to tofacitinib MR 11mg with continued MTX, as measured by the change in the Disease Activity Score utilizing 4 components including erythrocyte sedimentation rate (DAS28-4 (ESR)) from randomization (at Week 24) to the end of the double-blind MTX withdrawal phase (at Week 48).
Study Plan
All eligible subjects enrolled in the study will initially receive open-label tofacitinib combined with MTX for 24 weeks (run-in phase). At the end of the 24-week open-label runin phase, only subjects who achieve Low Disease Activity (LDA) (as assessed by CDAI =10) will be randomized to the 24-week double-blind, placebo-controlled, MTX withdrawal phase. Subjects who do not achieve the LDA (as assessed by CDAI>10) at this time point will be discontinued from the study.
Open Enrollment
Contact Name: Fallon Callon
Contact Phone: (904)633-0071
Investigators

Principal Investigator
Gurjit S. Kaeley, M.D.
Medicine

Sub Investigator
Karishma Ramsubeik, M.B.B.S. (M.D.)
Medicine

Sub Investigator
Myint Thway, M.D.
Medicine