Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)
Purpose
The purpose of this study is to determine if tofacitinib is safe and effective in subjects with active ankylosing spondylitis.
Condition
- Ankylosing Spondylitis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Tofacitinib |
|
|
Placebo Comparator Placebo |
|
More Details
- Status
- Completed
- Sponsor
- Pfizer