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

NCT ID: NCT00503139

Last Updated: 2017-02-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 684 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2013-04-30

Brief 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.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Enbrel (etanercept)

Enbrel 10 to 25 mg twice a week subcutaneous injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Hokkaido University Hospital

Sapporo, , Japan

Countries

Japan

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0881A1-4426&StudyName=Study%20Evaluating%20the%20Safety%20and%20Efficacy%20of%20Enbrel%20%28Etanercept%29%20in%20Japan

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Other Identifiers

B1801045

Identifier Type: OTHER

Identifier Source: secondary_id

0881A1-4426

Identifier Type: -

Identifier Source: org_study_id