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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.
ClinicalTrials.gov Identifier: NCT00484809
Recruitment Status : Completed
First Posted : June 11, 2007
Last Update Posted : December 14, 2007
Sponsor:
Information provided by:

Study Description
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 Phase
Rheumatoid Arthritis Drug: Enbrel (Etanercept) Phase 4

Study Design

Study Type : Observational
Estimated 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
Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00484809


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information

ClinicalTrials.gov Identifier: NCT00484809     History of Changes
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:
Arthritis
Arthritis, Rheumatoid
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors