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Study Investigating Enbrel Treatment for Ankylosing Spondylitis

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: NCT00195416
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : September 16, 2009
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:

To identify the following problems and questions with respect to the safety and effectiveness of Enbrel during the post-marketing period as required by Korea Food and Drug Administration (KFDA)'s regulations.

  1. Unknown adverse reactions, especially serious adverse reactions
  2. Change of the incidences of adverse reactions under the routine drug uses
  3. Factors that may affect the safety of the drug
  4. Factors that may affect the effectiveness of the drug

Condition or disease Intervention/treatment
Ankylosing Spondylitis Drug: Etanercept

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Study Type : Observational
Actual Enrollment : 526 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Drug Use Investigation of Enbrel for Post-marketing Surveillance (PMS) for Ankylosing Spondylitis
Study Start Date : June 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept

Intervention Details:
  • Drug: Etanercept
    Etanercept 25mg Injection, 2 times/week

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic, secondary and tertiary medical centers

Inclusion Criteria:

  • Adults: Severe ankylosing spondylitis (AS) in patients who do not respond adequately to previous therapy

Exclusion Criteria:

  • Patients with known hypersensitivity to Enbrel or any component of the product
  • Patients with sepsis or risk of sepsis
  • Patients with active infections including chronic or localized infections such as tuberculosis.

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): NCT00195416

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Korea, Republic of
Gyunggi-do, Korea, Republic of, 463-707
Seoul, Korea, Republic of, 140-575
Seoul, Korea, Republic of, 143-914
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
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Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth Identifier: NCT00195416    
Other Study ID Numbers: 0881A-102018
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 16, 2009
Last Verified: September 2009
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Ankylosing Spondylitis
Additional relevant MeSH terms:
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Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint 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