NCT01786668

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)

Completed Phase 2 Results posted Last updated 4 May 2016

What this trial tests

Phase 2 trial testing Tofacitinib 2 mg in Ankylosing Spondylitis in 208 participants. Completed in 1 March 2015.

Timeline

1 April 2013

Primary endpoint
1 March 2015

1 March 2015

Quick facts

Lead sponsor	Pfizer
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	208
Start date	1 April 2013
Primary completion	1 March 2015
Estimated completion	1 March 2015
Sites	67 locations across United States, Canada, Czechia, Germany, Hungary, Poland, Russia, South Korea

Drugs / interventions tested

• Tofacitinib 2 mg — full drug profile →
• Tofacitinib 5 mg (tofacitinib-5-mg) — full drug profile →
• Tofacitinib 10 mg — full drug profile →
• Placebo

Conditions studied

• Ankylosing Spondylitis — all drugs for Ankylosing Spondylitis →

Sponsor

Pfizer — full company profile →

Who can join

18 and older, any sex, with Ankylosing Spondylitis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 12
  Time frame: Week 12
  The primary analysis of this outcome measure was performed using the Emax model. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of greater than or equal to (≥) 20% and ≥1 unit in at least 3 domains (on a scale of 0 \[least\] to 10 \[worst\]) and no worsening of ≥20% and less than or equal to (≤)1 unit in the remaining domain. The domains
• Percentage of Participants Achieving ASAS20 at Week 12
  Time frame: Baseline, Week 12
  The supportive analysis of this outcome measure was performed using the normal approximation for two proportions. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 \[least\] to 10 \[worst\]) and no worsening of ≥20% and ≤1 unit in the remaining domain. The domains are: Patient's Glo

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.