Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01932372|
Recruitment Status : Active, not recruiting
First Posted : August 30, 2013
Last Update Posted : September 10, 2019
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.
|Condition or disease||Intervention/treatment|
|Rheumatoid Arthritis||Drug: Tofacitinib (Xeljanz) Drug: Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc|
|Study Type :||Observational|
|Actual Enrollment :||10477 participants|
|Official Title:||XELJANZ (REGISTERED) TABLETS 5MG SPECIAL INVESTIGATION (ALL-CASES SURVEILLANCE)|
|Actual Study Start Date :||July 26, 2013|
|Estimated Primary Completion Date :||December 15, 2020|
|Estimated Study Completion Date :||December 15, 2020|
Tablets 5 mg BID
Drug: Tofacitinib (Xeljanz)
5 mg Tablet BID
Standard of Care
Standard of Care for Rheumatoid Arthritis
Drug: Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc
Etanercept: 10 to 25 mg twice weekly, or 25 to 50 mg once weekly
- Disease Activity Score Based on 28-joints Count (DAS28) [ Time Frame: 24 months ]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.
- Percentage of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: 36 months ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932372
|Study Director:||Pfizer CT.gov Call Center||Pfizer|