Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01932372

Collaborator

(none)

9,968

Enrollment

Location

Actual Duration (Months)

102.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this Surveillance is to verify the following subject matters concerning Tofacitinib (Xeljanz) under general practice.

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	Phase
Rheumatoid Arthritis	Drug: Tofacitinib (Xeljanz) Drug: Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

9968 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 26, 2013

Actual Primary Completion Date :

Aug 24, 2021

Actual Study Completion Date :

Aug 24, 2021

Arms and Interventions

Arm	Intervention/Treatment
Tofacitinib (Xeljanz) 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

Arm

Intervention/Treatment

Tofacitinib (Xeljanz)

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

Outcome Measures

Primary Outcome Measures

Disease Activity Score Based on 28-joints Count (DAS28) [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) [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.