No registrations found.
ID
Source
Brief title
Health condition
ankylosing spondylitis, Bechterew, TNF blocker, spondylitis ankylopoetica, spondyloarthritis, TNF blokker
Sponsors and support
Intervention
Outcome measures
Primary outcome
the presence of an AS disease flare (ASDAS of 2.1 or higher during at least 2 weeks).
Secondary outcome
- parameters of body composition:
anthropometrical measurements and DEXA parameters (e.g. body fatt, lean mass)
- other parameters of AS disease activity (BASDAI, VAS, BASFI, BASMI, 44 joint count, quality of life)
- the presence of extra articular manifestations
- cardiovascular risk factors
- through levels of TNF inhibitor
Background summary
Women have been fairly underrepresented in studies of ankylosing spondylitis (AS). This is unfortunate since there are important gender differences in AS and women appear to respond less well to treatment with TNF-alpha inhibitors (TNFi). So far it is unknown whether there are also gender differences in the reaction to tapering of TNFi, while tapering currently becomes more and more standard practise in patients with sustained disease activity.
Differences in the response to TNFi (treatment and tapering) could possibly be due to gender differences in body composition.
The current study includes AS patients who start to taper their TNF blocker. Primarily the gender difference in the risk of an AS disease flare will be studied, and the association with baseline body composition. The follow up is 1 year.
Study objective
Men and women do not have the same risk of an ankylosing spondylitis (AS) disease flare during tapering of their TNF blockers. If so, this could probably be associated with differences in body composition.
Study design
Baseline - 3 months - 6 months - 9 months - 12 months (end of study)
Intervention
TNF blockers will be tapered by using a predefined schedule of prolongation (doubling) of the dosinginterval.
Also: a whole body DEXA scan will be performed (2x) and blood samples will be collected
I.E. van der Horst-Bruinsma
De Boelelaan 1117, 1081 HV Amsterdam
Amsterdam 1081 HV
The Netherlands
0031 (0)20 4445085
secr.reumatologie@vumc.nl
I.E. van der Horst-Bruinsma
De Boelelaan 1117, 1081 HV Amsterdam
Amsterdam 1081 HV
The Netherlands
0031 (0)20 4445085
secr.reumatologie@vumc.nl
Inclusion criteria
• 18 years or older
• AS (radiographic axial spondyloarthritis) according to the 1984 modified New York Criteria
• Use of a TNF-alpha blocker, stable dose during the last 6 months
• ≥6 months: Low (inactive or moderate) disease activity based on the ASDAS-CRP (<2.1) or, if unavailable, according to the clinical evaluation of the treating physician.
• At study entrance: ASDAS <2.1.
Exclusion criteria
• Planned reasons for treatment discontinuation (e.g. pregnancy)
• Unable to understand the study aims and methods
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6674 |
| NTR-old | NTR6844 |
| CCMO | NL62504.029.17 |
| OMON | NL-OMON46502 |