Study Investigating Enbrel Treatment for Ankylosing Spondylitis

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00195416

Enrollment

526

Registered

2005-09-19

Start date

2005-06-30

Completion date

2008-08-31

Last updated

2009-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing Spondylitis

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

Interventions

DRUGEtanercept

Etanercept 25mg Injection, 2 times/week

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026