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NCT00503139 Clinical Trial

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

Rheumatoid Arthritis Clinical Trial

Official title:
Long Term Safety and Efficacy From Special Surveillance for Etanercept in Japan

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00503139
Other study ID # 0881A1-4426
Secondary ID
Status Completed
Phase N/A
First received July 16, 2007
Last updated February 14, 2014
Start date June 2007
Est. completion date April 2013

Study information
Verified date February 2014
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 684
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Enbrel (etanercept)
Enbrel 10 to 25 mg twice a week subcutaneous injection

Locations
Country Name City State
Japan Pfizer Investigational Site Sapporo

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

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