Gender differences and changes in body composition during tapering of TNF blockers in patients with ankylosing spondylitis.

Recruiting

• Conditions: ankylosing spondylitis; Bechterew's disease; 10003816; 10023213

• Registration Number: NL-OMON46502
• Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 190

Inclusion Criteria

- 18 years or older
- Diagnosis of ankylosing spondylitis (radiographic axial spondyloarthritis) according to the 1984 modified New York criteria
- Use of a TNF-alpha blocker, stable dose during the last 6 months.
- At least 6 months of low disease activity in the 6 months prior to study entrance.
- Low disease activity at study entrance.

Exclusion Criteria

- Planned reasons for treatment discontinuation
- Unable to understand the study aims and methods.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The number of patients (percentage men / women) that develop a flare within 1<br /><br>year after tapering will be the primary outcome measure. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Patient- and disease characteristics, anthropometric measures, fat mass and *<br /><br>distribution, physical performance parameters, quality of life and<br /><br>cardiovascular risk profile will be collected as secondary outcomes. In future,<br /><br>pharmacokinetic/ -dynamic measures and changes in the coagulation profile will<br /><br>be evaluated from the stored samples (future study protocols). </p><br>