Etanercept (Enbrel) Special Investigation (Regulatory Post Marketing Commitment Plan)

Pfizer

Status: Completed

Conditions: Arthritis; Rheumatoid

Treatments: Drug: etanercept (genetical recombination)

Study type: Observational

Funder types: Industry

Identifiers

NCT01230177

B1801134

Details and patient eligibility

About

This survey is conducted to investigate safety and efficacy under the post marketed drug utilization on the patient with rheumatoid arthritis (only for patients with an inadequate response to prior conventional therapy) at the time of switching regimen from 10 mg twice a week administration to 25 mg once a week administration.

Full description

Implemented as a Special Investigation by Central Registration System

Enrollment: 3 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients need to be administered etanercept in order to be enrolled in the survey
• Patients who have changed regimen from 10 mg twice a week administration to 25 mg once a week administration.

Exclusion criteria

• Patients who have been administered etanercept 50mg once a week
• Patients who have been administered etanercept 25mg once a week

Trial design

3 participants in 1 patient group

Etanercept (genetical recombination)

Description:

Among the patients with rheumatoid arthritis (only for patients with an inadequate response to prior conventional therapy), the patients who will have changed regimen from 10 mg twice a week administration to 25 mg once a week administration.

Treatment:

Drug: etanercept (genetical recombination)