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

NCT03502616

Last updated date
Study Location
The First Affiliated Hosptial of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Contact
1-800-718-1021

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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.


- History of allergies, intolerance or hypersensitivity to lactose or tofacitinib.


- History of any other rheumatic disease.


- Any subject with condition affecting oral drug absorption.

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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
  • Experimental: Tofacitinib
    Intervention: Drug: Tofacitinib
  • Placebo Comparator: Placebo
    Intervention: Drug: Tofacitinib
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
 (submitted: September 18, 2019)
270
Original Estimated Enrollment  ICMJE
 (submitted: April 11, 2018)
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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP