Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis

Sponsor
Pfizer
Study ID
NCT01932372
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Tofacitinib (Xeljanz) — DRUG
    5 mg Tablet BID
  • Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc — DRUG
    Etanercept: 10 to 25 mg twice weekly, or 25 to 50 mg once weekly

Study Details

The objective of this Surveillance is to verify the following subject matters concerning Tofacitinib (Xeljanz) under general practice. 1\) Occurrence of adverse reactions, factors that may potentially affect safety and efficacy 2） Long-term safety (particularly, malignant tumors and serious infections) and efficacy Occurrences of malignant tumors and serious infections will be compared with a control group.

Key Dates

Start date
Jul 26, 2013
Status verified
Jul 2024
Primary completion
Aug 24, 2021
Completion
Aug 24, 2021

Study Design

Enrollment
9,968 participants (actual)

Arms

  • Arm: Tofacitinib (Xeljanz)
    Tablets 5 mg BID
  • Arm: Standard of Care
    Standard of Care for Rheumatoid Arthritis

Primary Outcome Measure

Percentage of Participants With Treatment-related Adverse Events or Serious Treatment-related Adverse Events in Participants Who Received XELJANZ [ Time Frame: 36 months ]

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