Study Investigating Enbrel Treatment for Ankylosing Spondylitis

Wyeth

Status: Completed

Conditions: Ankylosing Spondylitis

Treatments: Drug: Etanercept

Study type: Observational

Funder types: Industry

Identifiers

NCT00195416

0881A-102018

Details and patient eligibility

About

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

Enrollment: 526 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.