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

Sponsor
Pfizer
Study ID
NCT03486457
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib — DRUG
    tablets, 5 mg BID x 6 months
  • Placebo — OTHER
    tablets, to match tofacitinib 5 mg BID x 3 months
  • Tofacitinib — DRUG
    tablets, 5 mg BID x 3 months

Study Details

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.

Key Dates

Start date
Aug 10, 2018
Status verified
Jun 2023
Primary completion
Apr 28, 2021
Completion
Apr 28, 2021

Study Design

Enrollment
204 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Sequence A
    Tofacitinib 5 mg BID for 6 months
  • Placebo Comparator: Treatment Sequence B
    Placebo for 3 months then tofacitinib 5 mg BID for 3 months

Primary Outcome Measure

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 3 [ Time Frame: Month 3 ]

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