CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 208 enrolled
Drug / intervention
Tofacitinib 2 mg +3 moredrug
Likely dose
Tofacitinib 2 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/NCT01786668
NCT01786668Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (as)

Pfizer·interventional·Posted Feb 8, 2013·Updated Jun 10, 2016

In Brief

A Phase 2 clinical trial evaluating Tofacitinib 2 mg, Tofacitinib 5 mg, and 2 other interventions for Ankylosing Spondylitis. Completed, enrolled 208 participants across 67 sites in 10 countries.

Detailed Summary

This is the first study of oral tofacitinib in adults with active ankylosing spondylitis. It is designed to obtain information on the efficacy and safety of 3 different doses of tofacitinib.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnkylosing Spondylitis
CountriesCanada, Czechia, Germany, Hungary, Poland, Russia, South Korea, Spain, Taiwan, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 8, 2013
Enrollment StartApr 1, 2013
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 13.4 years ago

Interventions

Tofacitinib 2 mgdrug

4 blinded tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks

Tofacitinib 5 mgdrug

4 blinded tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks

Tofacitinib 10 mgdrug

4 blinded tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks

Placebodrug

4 blinded tablets (two 1 mg and two 5 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks