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

Last updated on August 9, 2018

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Study Location
Contact
1-800-718-1021
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

NCT03486457
Pfizer
Not yet recruiting
Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis

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Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Psoriatic Arthritis
  • 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
  • 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
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
153
May 7, 2020
May 7, 2020   (Final data collection date for primary outcome measure)

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
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
 
 
NCT03486457
A3921234
Yes
Studies a U.S. FDA-regulated Drug Product: No
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
March 2018

ICMJE     Data element required by the

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

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