Purpose

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

Condition

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

More Details

NCT ID
NCT03502616
Status
Active, not recruiting
Sponsor
Pfizer

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.