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

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ankylosing Spondylitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

- Subject who has previously participated in any study of tofacitinib.

- History of any other rheumatic disease.

- Any subject with condition affecting oral drug absorption.

NCT03502616
Pfizer
Not yet recruiting
Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)

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Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)
A Phase 3, Randomized, Double Blind, Placebo Controlled, Study Of The Efficacy And Safety Of Tofacitinib In Subjects With Active Ankylosing Spondylitis (as)
The purpose of this study is to determine if tofacitinib is safe and effective in subjects with active ankylosing spondylitis.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Ankylosing Spondylitis
Drug: Tofacitinib
Oral administration twice per day
  • Experimental: Tofacitinib
    Intervention: Drug: Tofacitinib
  • Placebo Comparator: Placebo
    Intervention: Drug: Tofacitinib
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
240
Same as current
August 2, 2020
August 2, 2020   (Final data collection date for primary outcome measure)

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.
  • Subject who has previously participated in any study of tofacitinib.
  • History of any other rheumatic disease.
  • Any subject with condition affecting oral drug absorption.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03502616
A3921120
AS ( Other Identifier: Alias Study Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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