Prospective follow-up study of golimumab treatment in psoriatic arthritis
Phase 4
- Conditions
- psoriatic arthritis100038161002321310014982
- Registration Number
- NL-OMON37425
- Lead Sponsor
- Jan van Breemen Instituut
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
patients with psoriatic arthritis 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>- ACR20 response: 20% improvement or 10 point decrease on 100mm VASscales<br /><br>- PASI improvement<br /><br>- MDA status</p><br>
- Secondary Outcome Measures
Name Time Method <p>-The number of adverse events (infections, malignancies, mortality)<br /><br>- LEI Improvement<br /><br>-Number of digits with dactylitis<br /><br>-Number of nails with nail psoriasis<br /><br>-ESR and/or CRP<br /><br>-The lipid profile<br /><br>-inflammation processes<br /><br>-Relation between genetic polymorphisms and the efficacy of golimumab<br /><br>-Radiographic progression<br /><br>-Changes in bone mineral density.</p><br>