Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)
NCT03502616
Last updated date
ABOUT THIS STUDY
The purpose of this study is to determine if tofacitinib is safe and effective in subjects
with active ankylosing spondylitis.
Study Location
The First Affiliated Hosptial of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
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
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.
- History of allergies, intolerance or hypersensitivity to lactose or tofacitinib.
- History of any other rheumatic disease.
- Any subject with condition affecting oral drug absorption.
NEED INFO?
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Advanced Information
| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS) | ||||||
| Official Title ICMJE | A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS) | ||||||
| Brief Summary | The purpose of this study is to determine if tofacitinib is safe and effective in subjects with active ankylosing spondylitis. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 3 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||||||
| Condition ICMJE | Ankylosing Spondylitis | ||||||
| Intervention ICMJE | Drug: Tofacitinib
Oral administration twice per day | ||||||
| Study Arms ICMJE |
| ||||||
| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE | 270 | ||||||
| Original Estimated Enrollment ICMJE | 240 | ||||||
| Actual Study Completion Date ICMJE | August 20, 2020 | ||||||
| Actual Primary Completion Date | December 19, 2019 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
| Sex/Gender ICMJE |
| ||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Australia, Bulgaria, Canada, China, Czechia, France, Hungary, Israel, Korea, Republic of, Poland, Russian Federation, Turkey, Ukraine, United States | ||||||
| Removed Location Countries | Slovakia, Spain, Taiwan | ||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03502616 | ||||||
| Other Study ID Numbers ICMJE | A3921120 AS ( Other Identifier: Alias Study Number ) 2018-000226-58 ( EudraCT Number ) | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product |
| ||||||
| IPD Sharing Statement ICMJE |
| ||||||
| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
| ||||||
| PRS Account | Pfizer | ||||||
| Verification Date | December 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||