This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatments tofacitinib (xeljanz), etanercept, other biologics, disease-modifying antirheumatic drugs (dmards), etc
Sponsor Pfizer
Start date July 2013
End date February 2020
Trial size 6000 participants
Trial identifier NCT01932372, A3921194


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Tablets 5 mg BID
tofacitinib (xeljanz)
5 mg Tablet BID
Standard of Care for Rheumatoid Arthritis
etanercept, other biologics, disease-modifying antirheumatic drugs (dmards), etc
Etanercept: 10 to 25 mg twice weekly, or 25 to 50 mg once weekly

Primary Outcomes

Disease Activity Score Based on 28-joints Count (DAS28)
time frame: 24 months
Percentage of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs)
time frame: 36 months

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - All patients receiving Tofacitinib (Xeljanz) Exclusion Criteria:

Additional Information

Official title Tofacitinib Special Investigation Of Xeljanz Tablets 5mg. (Regulatory Post Marketing Commitment Plan)
Description All the patients whom an investigator prescribes the Xeljanz or Standard of Care for rheumatoid arthritis should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Pfizer.