Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis
This trial is active, not recruiting.
|Treatments||tofacitinib (xeljanz), etanercept, other biologics, disease-modifying antirheumatic drugs (dmards), etc|
|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.
Tablets 5 mg BID
Standard of Care for Rheumatoid Arthritis
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
All participants of any age.
Inclusion Criteria: - All patients receiving Tofacitinib (Xeljanz) Exclusion Criteria:
|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.|
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