Spondyloarthritis MedDRA version: 16.1 Level: LLT Classification code 10032155 Term: Other inflammatory spondylopathies System Organ Class: 100000004859 MedDRA version: 16.1 Level: LLT Classification code 10070759 Term: Spondylopathy System Organ Class: 100000004859
Conditions
Sponsors
Academic Medical Center, Department of Rheumatology
Eligibility
Sex/Gender
All
Inclusion criteria
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 - stable dose of concomitant medication (NSAIDs etc.) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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) - Significant medical problems or diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efect of IL-17 blockade on: - the global synovial histology and inflammatory infiltration - the number and type of IL-17 producing cells in SpA synovitis - the productuion of inflammatory mediators (including other IL-17 related cytokines and TNF) by PBMC and total tissue biopsies (ex vivo culture system) - The synovial stromal cell signature - The pan-genomic synovial gene expression profile\ ;Secondary Objective: Secondary: To compare wich molecular disease pathways are affected by IL-17 blockade and not by TNF blockade and thereby identify molecular biomarkers which may help to determine which patients may benefit form this treament in comparison with anti-TNF treatment. To assess wether AIN457 sileces vessel wall inflammation (by means of 18F-FDG PET/CT of the carotic arteries and aorta.;Primary end point(s): - Changes in the synovial cellular and molecular pathways as indicated in the objectives between baseline and week 12;Timepoint(s) of evaluation of this end point: baseline compared with week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Stratification of these cellular and molecular changes according to the genetic biomarkers of relevance for anti-IL17 treatment response - Correlation between the synovial features at baseline and the clinical response at week 12 - Comparison of the synovial molecular changes induced by anti-IL17 with the changes induced by anti-TNF (historical samples in a similar patient population and study setting) - Comparison of the changes in Target to Background Ration (TBR) as an indicator of vessel wall inflammation assessed by FDG PET/CT of the aorta and carotid arteries ;Timepoint(s) of evaluation of this end point: week 12 | — |
Countries
Netherlands
Contacts
Public Contactdepartment of Rheumatology
Academic Medical Center, department of Rheumatology
Outcome results
None listed