Study Evaluating the Safety and Efficacy of Enbrel (Etanercept) in Japan

Pfizer

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: Enbrel (etanercept)

Study type: Observational

Funder types: Industry

Identifiers

NCT00503139

B1801045 (Other Identifier)

0881A1-4426

Details and patient eligibility

About

The special use-results surveillance is conducted in patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted in the actual setting of use after marketing with the following objectives: 1. To examine the safety of long-term use of Enbrel including the occurrence of malignant tumors. 2. To confirm the efficacy of Enbrel in the long-term use.

Enrollment: 684 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Inclusion Criteria Patients with rheumatoid arthritis (RA) who fulfill all of the following

1. Patients who are refractory to the treatment.
2. Patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted.
3. Patients without a history of or concurrent malignant tumors.

Exclusion Criteria: