Mechanism of action study of anti-IL17 therapy in spondyloarthritis: impact on cellular and molecular pathways of synovial inflammation and tissue remodelling.
Phase 2
Completed
- Conditions
- ankylosing spondylitisSpondylarthropathy1000381610023213
- Registration Number
- NL-OMON41538
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion Criteria
-Male or non-pregnant/non-lactating females age 18-70
- Diagnosis of SpA according to ESSG criteria and/or ASAS criteria
- Active disease defined by *1 swollend and * 1 tender joint, and at least 1 swollen knee or ankle joint at baseline
Exclusion Criteria
- Evidence for infectious or malignant process (on chest X ray/MRI etc)
- Pts taking opioid angalgetics
- Previous IL-17 therapy exposure
- Previous use of celldepleting therapies, biological immunomodulants (except for a.TNF)
- no more then 50% of included patients are allowed to be previously exposed to (1) TNF blocking agent
- Significant medical problems or diseases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Changes in the synovial cellular and molecular pathways as indicated in the<br /><br>objectives between baseline and week 12</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Stratification of these cellular and molecular changes according to the<br /><br>genetic biomarkers of relevance for anti-IL17 treatment response<br /><br>- Correlation between the synovial features at baseline and the clinical<br /><br>response at week 12<br /><br>- Comparison of the synovial molecular changes induced by anti-IL17 with the<br /><br>changes induced by anti-TNF (historical samples in a similar patient population<br /><br>and study setting)<br /><br>- Comparison of the changes in Target to Background Ration (TBR) as an<br /><br>indicator of vessel wall inflammation assessed by FDG PET/CT of the aorta and<br /><br>carotid arteries </p><br>