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van CCT (UK)

De relatie tussen geslacht, lichaamssamenstelling en het succesvol kunnen verminderen van medicijnen (TNF blokkers) bij patiënten met de ziekte van Bechterew.

- candidate number28302
- NTR NumberNTR6844
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-dec-2017
- Secondary IDsNL62504.029.17 METC
- Public TitleDe relatie tussen geslacht, lichaamssamenstelling en het succesvol kunnen verminderen van medicijnen (TNF blokkers) bij patiënten met de ziekte van Bechterew.
- Scientific TitleGender differences and changes in body composition during tapering of TNF blockers in patients with ankylosing spondylitis
- hypothesisMen 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.
- Healt Condition(s) or Problem(s) studiedBechterew's disease (Ankylosing spondylitis), Spondyloarthritis, TNF blocker
- 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
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 6-dec-2017
- planned closingdate1-dec-2020
- Target number of participants190
- InterventionsTNF 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
- Primary outcomethe 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
- TimepointsBaseline - 3 months - 6 months - 9 months - 12 months (end of study)
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. I.E. van der Horst-Bruinsma
- CONTACT for SCIENTIFIC QUERIESDr. I.E. van der Horst-Bruinsma
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryWomen 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.
- Main changes (audit trail)
- RECORD5-dec-2017 - 12-dec-2017

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