Mechanism of action study of anti-IL17 therapy in spondyloarthritis: impact on cellular and molecular pathways of synovial inflammation and tissue remodelling.

Mechanism of action study of anti-IL17 therapy in spondyloarthritis: impact on cellular and molecular pathways of synovial inflammation and tissue remodelling. - MoA IL-17 in Spondyloarthritis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41538

Enrollment

Registered

2014-01-07

Start date

2014-02-18

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ankylosing spondylitis Spondylarthropathy

Interventions

Secukinumab (AIN457) by monthly subcutanious injections.

Eligibility

Age

18 Years to 99 Years

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

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) - no more then 50% of included patients are allowed to be previously exposed to (1) TNF blocking agent - Significant medical problems or diseases

Design outcomes

Primary

Measure	Time frame
- Changes in the synovial cellular and molecular pathways as indicated in the objectives between baseline and week 12	—

Secondary

Measure	Time frame
- 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	—

Measure

Time frame

- 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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)