Study Evaluating the Tolerance and Safety of Enbrel (Etanercept) in Adults and Children

Rheumatoid Arthritis Clinical Trial

Official title:

A Post-Marketing Surveillance Looking at Safety of Enbrel (Etanercept) in Adults With Active Rheumatoid Arthritis (RA) and Children With Juvenile Rheumatoid Arthritis (JRA).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00484809
• Other study ID #: 0881A-101511
• Status: Completed
• Phase: Phase 4
• First received: June 8, 2007
• Last updated: December 11, 2007
• Start date: March 2004
• Est. completion date: February 2006

Study information

• Verified date: December 2007
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Observational

Clinical Trial Summary

This postmarketing surveillance study will evaluate the safety profile of Enbrel (etanercept) in an Indian population. It will provide surveillance on a currently approved indication for Enbrel of reducing symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years and older

Eligibility

Inclusion Criteria:

• Inclusion in this study will be as per the approved indications in the package insert.

• Patients with moderately to severely active RA.

• Children with JRA who have had an inadequate response to one or more DMARDs.

Exclusion Criteria:

• Known hypersensitivity to etanercept or any of its components.

• Known significant concurrent medical disease, including:

• Congestive heart failure, uncontrolled angina pectoris, recent history of myocardial infarction

• Cancer or history of cancer

• Active infection

• Sepsis or risk of sepsis

• Active tuberculosis or a past history of tuberculosis

• Pancytopenia

• Females who are pregnant, breast feeding or at risk of pregnancy and not using a medically acceptable form of contraception.

• Patients who are planning to undergo elective surgery during the study period.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Enbrel (Etanercept)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer