CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 209 enrolled
Drug / intervention
Tofacitinib +1 moredrug
Likely dose
Tofacitinib 11 mgfrom 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/NCT02281552
NCT02281552Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-blind, Parallel-group, Phase 3 Study To Demonstrate Non-inferiority For The Efficacy Of A Once Daily Dose Of Tofacitinib Modified Release Tablet To A Twice Daily Dose Of The Immediate Release Tablet In Adult Patients With Rheumatoid Arthritis On Background Methotrexate

Pfizer·interventional·Posted Nov 3, 2014·Updated Oct 12, 2018

In Brief

A Phase 3 clinical trial evaluating Tofacitinib for Rheumatoid Arthritis. Completed, enrolled 209 participants across 36 sites.

Detailed Summary

This is a 12 week study that will evaluate the efficacy and safety of the 11 mg tofacitinib modified release tablet taken once a day in patients with rheumatoid arthritis who continue taking methotrexate. Results for the modified release tablets will be compared to the efficacy and safety of the 5 mg tofacitinib immediate release tablets taken twice a day in patients with rheumatoid arthritis who continue taking methotrexate.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 3, 2014
Enrollment StartNov 18, 2014
Primary CompletionMar 15, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.7 years ago

Interventions

Tofacitinibdrug

tofacitinib modified release 11 mg tablet administered once time a day for 12 weeks

Tofacitinibdrug

tofacitinib immediate release 5 mg tablet administered twice a day for 12 weeks