Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)

• Status: Completed
• Trial end date: 2020-08-20
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if tofacitinib is safe and effective in subjects with active ankylosing spondylitis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Tofacitinib

Criteria

Inclusion Criteria:

• Has a diagnosis of Ankylosing Spondylitis (AS) based on the Modified New York Criteria for AS (1984).

• Must have a radiograph of SI joints (AP Pelvis) documenting diagnosis of AS.

• Has active disease despite nonsteroidal anti-inflammatory drug (NSAID) therapy or intolerant to NSAIDs.

Exclusion Criteria:

• History of known or suspected complete ankylosis of the spine.

• History of allergies, intolerance or hypersensitivity to lactose or tofacitinib.

• History of any other rheumatic disease.

• Any subject with condition affecting oral drug absorption.