Prospective follow-up study of adalimumab treatment in ankylosing spondylitis: efficacy with focus on uveitis
Phase 4
Recruiting
- Conditions
- Ankylosing spondylitisBechterew's disease10023213
- Registration Number
- NL-OMON30515
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Ankylosing spondylitis according to the modified New York criteria, who will start with adalimumab.
Exclusion Criteria
1. Persistent chronic or active infections
2. History of amlignancy
3. Immuno-compromised conditions.
4. History of central nervous system (CNS) demyelinating disease.
5. Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study.
6. Known history of allergic reaction or significant hypersensitivity to the constituents of adalimumab.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary:<br /><br>- ASAS 20% response<br /><br>- occurrence of attacks of uveitis.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary: adverse events, improvement of mobility, swollen joints,<br /><br>inflammatory markers, and radiographic progression.</p><br>