CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 109 enrolled
Drug / intervention
Tasocitinib plus Methotrexate +2 moredrug
Likely dose
Tasocitinib plus Methotrexate 10 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/NCT01164579
NCT01164579Phase 2Completed
CompareCT.gov

An Exploratory Phase 2, Randomized, Double-blind, Multicenter Study To Assess The Effects Of Tofacitinib (Cp-690,550) On Magnetic Resonance Imaging Endpoints, In Methotrexate Naive Subjects With Early Active Rheumatoid Arthritis

Pfizer·interventional·Posted Jul 16, 2010·Updated Apr 22, 2015

In Brief

A Phase 2 clinical trial evaluating Tasocitinib plus Methotrexate, Tofacitinib plus placebo methotrexate, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 109 participants across 40 sites in 9 countries.

Detailed Summary

Evaluation of efficacy and safety of tofacitinib (CP-690,550) for the treatment of early rheumatoid arthritis in adult patients with moderate to severe disease who are methotrexate naïve. The efficacy will be evaluated by exploring the effects on joint structure assessed by magnetic resonance imaging, x-rays and by standard clinical assessment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesArgentina, Chile, Croatia, Czechia, Hungary, Mexico, Poland, Puerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 16, 2010
Enrollment StartOct 1, 2010
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 16.0 years ago

Interventions

Tasocitinib plus Methotrexatedrug

Tofacitinib (CP 690,550) 10 mg BID, tablets + methotrexate (MTX) 10 mg/wk to 20 mg/wk, titrated over 2 months

Tofacitinib plus placebo methotrexatedrug

Tofacitinib (CP-90,550) 10 mg BID, tablets. Placebo to match methotrexate (MTX) capsules titrated as in Treatment Arm 1.

Placebo tofacitinib plus Methotrexatedrug

Methotrexate (MTX) 10 mg/wk to 20 mg/wk, capsules, titrated over 2 months. Placebo in tablets to match tofacitinib