Korean Post-marketing Surveillance for Xeljanz XR

Sponsor
Pfizer
Study ID
NCT04876781
Status
Recruiting
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Conditions

  • Active Ankylosing Spondylitis
  • Active Moderate to Severe Rheumatoid Arthritis
  • Active Psoriatic Arthritis

Eligibility Criteria

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

Interventions

Study Details

Xeljanz XR extended-release tablets 11 mg (Tofacitinib citrate) is a drug subject to the risk management plan in accordance with Article 4-1-11 of the "Regulation on Safety of Medicinal Products, etc." in Korea. As part of additional pharmacovigilance activity, this Post-marketing Surveillance (PMS) was planned to evaluate safety and effectiveness of Xeljanz XR under routine clinical practice. At least 200 patients with Rheumatoid Arthritis, Psoriatic Arthritis, or Ankylosing Spondylitis who were treated with Xeljanz XR will be enrolled about four years.

Key Dates

Start date
Jan 12, 2022
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
200 participants (estimated)

Primary Outcome Measure

Number of Participants With Treatment Emergent Adverse Events (AEs) [ Time Frame: Maximum of 52 weeks from the time of initial administration of Xeljanz XR ]

Central Contacts