NCT01786668

Dose-Ranging Study Of Tofacitinib In Adults With Active Ankylosing Spondylitis

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	Tofacitinib 2 mg	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
DRUG	Tofacitinib 5 mg	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
DRUG	Tofacitinib 10 mg	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
DRUG	Placebo	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

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2013-02-08
• Last updated: 2016-06-10
• Results posted: 2016-06-10

Locations

67 sites across 10 countries: United States, Canada, Czechia, Germany, Hungary, Poland, Russia, South Korea, Spain, Taiwan