CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 694 enrolled
Drug / intervention
CP-690,550 +2 moredrug
Likely dose
CP-690,550 11mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02831855
NCT02831855Phase 4Completed
CompareCT.gov

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

Pfizer·interventional·Posted Jul 13, 2016·Updated Dec 4, 2019

In Brief

A Phase 4 clinical trial evaluating CP-690,550, Methotrexate, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 694 participants across 136 sites in 16 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesAustralia, Belgium, Bulgaria, Czechia, Germany, Hungary, Mexico, Philippines, Poland, Russia, Slovakia, South Africa, South Korea, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 13, 2016
Enrollment StartSep 1, 2016
Primary CompletionNov 19, 2018
Study CompletionDec 17, 2018
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 10.0 years ago

Interventions

CP-690,550drug

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.

Methotrexatedrug

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.

Placebodrug

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.