CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 686 enrolled
Drug / intervention
Tofacitinib +3 moredrug
Likely dose
Tofacitinib 5 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/NCT01976364
NCT01976364Phase 3Completed
CompareCT.gov

A LONG-TERM, OPEN-LABEL EXTENSION STUDY OF TOFACITINIB (CP-690,550) FOR THE TREATMENT OF PSORIATIC ARTHRITIS

Pfizer·interventional·Posted Nov 5, 2013·Updated May 21, 2020

In Brief

A Phase 3 clinical trial evaluating Tofacitinib, Methotrexate, and 1 other intervention for Arthritis, Psoriatic. Completed, enrolled 686 participants across 153 sites in 16 countries.

Detailed Summary

This is a Phase 3, long-term open-label extension study to evaluate the safety, tolerability and efficacy of tofacitinib in subjects with active PsA who have previously participated in randomized studies of tofacitinib for this indication. This study will include a sub-study to evaluate the efficacy, safety and tolerability of tofacitinib 5 mg BID administered as monotherapy after methotrexate withdrawal compared to tofacitinib 5 mg BID continued in combination with methotrexate. The sub-study will be available to subjects who have completed at least 24 months of participation in the open-label extension study and meet eligibility criteria for the sub-study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Psoriatic
CountriesAustralia, Belgium, Brazil, Bulgaria, Canada, Czechia, Germany, Hungary, Mexico, Poland, Russia, Slovakia, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 5, 2013
Enrollment StartFeb 17, 2014
Primary CompletionMay 20, 2019
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 12.7 years ago

Interventions

Tofacitinibdrug

Tofacitinib 5 mg tablet twice daily

Tofacitinibdrug

Tofactinib 10 mg tablet twice daily

Methotrexatedrug

Methotrexate 7.5-20 mg weekly

Placebo Methotrexatedrug

Placebo to match active methotrexate orally once a week