Prospective follow-up study of golimumab treatment in ankylosing spondylitis.
Phase 4
Recruiting
- Conditions
- Ankylosing Spondylitis1000381610023213
- Registration Number
- NL-OMON41382
- Lead Sponsor
- Jan van Breemen Instituut
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
patients with ankylosing spondylitis in whom golimumab treatment is started.
written informed consent
Exclusion Criteria
contraindications against golimumab treatment
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p> - ASAS20% response: When there is 20% improvement (and at least 10 points<br /><br>decrease on the 100mm VAS-scales) of at least three out of four domains of the<br /><br>following parameters: inflammation/morning stiffness (BASDAI), function<br /><br>(BASFI), pain (VAS) and patient global assessment (VAS), this therapy will be<br /><br>considered as effective.<br /><br>- ASDAS improvement<br /><br>- BASDAI 50 response </p><br>
- Secondary Outcome Measures
Name Time Method <p> - the number of adverse events (infections, malignancies, mortality)<br /><br>- improvement of mobility (BASMI)<br /><br>- the peripheral joint swelling (44 joint count)<br /><br>- the ESR and/or CRP<br /><br>- the lipid profile<br /><br>- the production of ANA<br /><br>- relation between genetic polymorphisms and the efficacy of golimumab<br /><br>- radiographic progression (conventional radiography, mSASSscore)<br /><br>- occurrence of extraspinal manifestations (uveitis, colitis, cardiovascular<br /><br>events)<br /><br>- changes in bone mineral density. </p><br>