Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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XELJANZ (REGISTERED) TABLETS 5MG SPECIAL INVESTIGATION (ALL-CASES SURVEILLANCE)

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Tofacitinib (Xeljanz)
* Drug: Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients receiving Tofacitinib (Xeljanz) Exclusion Criteria: Not Applicable

Ages Eligible for Study
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Minimum Age: 0 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Tofacitinib (Xeljanz)<br>Tablets 5 mg BID | Drug: Tofacitinib (Xeljanz)<br>* 5 mg Tablet BID<br>|
| Standard of Care<br>Standard of Care for Rheumatoid Arthritis | Drug: Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc<br>* Etanercept: 10 to 25 mg twice weekly, or 25 to 50 mg once weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity Score Based on 28-joints Count (DAS28) | DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. | 24 months | 
| Percentage of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis, Good Post Marketing Study Practice, Tofacitinib, Xeljanz, Regulatory Post Marketing Commitment Plan