Tofacitinib (Xeljanz) Special Investigation for Rheumatoid Arthritis

Pfizer

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: Tofacitinib (Xeljanz); Drug: Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc

Study type: Observational

Funder types: Industry

Identifiers

NCT01932372

A3921194

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9,968 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients receiving Tofacitinib (Xeljanz)

Exclusion criteria

Not Applicable

Trial design

9,968 participants in 2 patient groups

Tofacitinib (Xeljanz)

Description:

Tablets 5 mg BID

Treatment:

Drug: Tofacitinib (Xeljanz)

Standard of Care

Description:

Standard of Care for Rheumatoid Arthritis

Treatment:

Drug: Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc