COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00484809
Recruitment Status : Completed
First Posted : June 11, 2007
Last Update Posted : December 14, 2007
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: Enbrel (Etanercept)

Layout table for study information
Study Type : Observational
Enrollment : 100 participants
Time Perspective: Prospective
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).
Study Start Date : March 2004
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00484809

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Layout table for investigator information
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Layout table for additonal information Identifier: NCT00484809    
Other Study ID Numbers: 0881A-101511
First Posted: June 11, 2007    Key Record Dates
Last Update Posted: December 14, 2007
Last Verified: December 2007
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
rheumatoid arthritis
juvenile rheumatoid arthritis
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors