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

ArmDescriptionAssigned Intervention
Experimental
Tofacitinib
  • Drug: Tofacitinib
    Oral administration twice per day
Placebo Comparator
Placebo
  • Drug: Tofacitinib
    Oral administration twice per day

Recruiting Locations

Memorial Hermann Hospital Imaging
Houston, Texas 77030

More Details

NCT ID
NCT03502616
Status
Recruiting
Sponsor
Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com