Status:
COMPLETED
Mechanism of Action of Anti-IL17 Therapy in Peripheral Spondyloarthritis
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Novartis
Conditions:
Spondylarthropathies
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the mechanism of action on target tissue level of anti Interleukine-17 (anti-IL-17) an therapy in peripheral spondyloarthritis. Patients will be treated with...
Detailed Description
Background of the study: Spondyloarthritis is the second most frequent form of chronic inflammatory arthritis with a prevalence of 0.5%. It effects mainly young adults and leads to major functional h...
Eligibility Criteria
Inclusion
- 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 swollen and ≥ 1 tender joint, and at least 1 swollen knee or ankle joint at baseline
Exclusion
- Evidence for infectious or malignant process (on chest X ray/MRI etc)
- Patients taking opioid analgetics
- Previous IL-17 therapy exposure
- Previous use of cell-depleting therapies, biological immunomodulators (except for TNF blockade , as 25% may have been previously treated with 1 TNF blocking agent)
- Significant medical problems or diseases
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03358134
Start Date
March 1 2014
End Date
October 1 2017
Last Update
November 30 2017
Active Locations (1)
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1
Academic Medical Center Amsterdam
Amsterdam, North Holland, Netherlands, 1105AZ