Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis

NCT03486457

Last updated date
Study Location
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510080, China
Contact
1-800-718-1021

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1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriatic Arthritis
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

- Chinese patients

- Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints

- Active plaque psoriasis at screening

- Inadequate response to at least one conventional synthetic DMARD

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


- Non-plaque forms of psoriasis (with exception of nail psoriasis)


- History of autoimmune rheumatic disease other than PsA; also prior history of or
current, rheumatic inflammatory disease other than PsA

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Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis
Official Title  ICMJE A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB (CP-690,550) IN CHINESE SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS AND AN INADEQUATE RESPONSE TO AT LEAST ONE CONVENTIONAL SYNTHETIC DMARD
Brief Summary This is a 6 month study investigating the effectiveness and safety of tofacitinib in treating signs and symptoms and improving physical function in Chinese patients with active psoriatic arthritis and had inadequate response to a conventional synthetic disease modifying anti-rheumatic drug. This is a China alone study.
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 Psoriatic Arthritis
Intervention  ICMJE
  • Drug: Tofacitinib
    tablets, 5 mg BID x 6 months
  • Other: Placebo
    tablets, to match tofacitinib 5 mg BID x 3 months
  • Drug: Tofacitinib
    tablets, 5 mg BID x 3 months
Study Arms  ICMJE
  • Experimental: Treatment Sequence A
    Tofacitinib 5 mg BID for 6 months
    Intervention: Drug: Tofacitinib
  • Placebo Comparator: Treatment Sequence B
    Placebo for 3 months then tofacitinib 5 mg BID for 3 months
    Interventions:
    • Other: Placebo
    • 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2018)
195
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2018)
153
Estimated Study Completion Date  ICMJE May 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Chinese patients
  • Active arthritis at screening/baseline as indicated by >/= 3 tender/painful and 3 swollen joints
  • Active plaque psoriasis at screening
  • Inadequate response to at least one conventional synthetic DMARD

Exclusion Criteria:

  • Non-plaque forms of psoriasis (with exception of nail psoriasis)
  • History of autoimmune rheumatic disease other than PsA; also prior history of or current, rheumatic inflammatory disease other than PsA
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: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03486457
Other Study ID Numbers  ICMJE A3921234
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
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 April 2020

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