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Prospective follow-up study of golimumab treatment in psoriatic arthritis

Phase 4
Conditions
psoriatic arthritis
10003816
10023213
10014982
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
NameTimeMethod
<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
NameTimeMethod
<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>
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