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NCT00195416 Clinical Trial

Study Investigating Enbrel Treatment for Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Official title:
A Drug Use Investigation of Enbrel for Post-marketing Surveillance (PMS) for Ankylosing Spondylitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00195416
Other study ID # 0881A-102018
Secondary ID
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated September 15, 2009
Start date June 2005
Est. completion date August 2008

Study information
Verified date September 2009
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 526
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

See also
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