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

Gender differences and changes in body composition during tapering of TNF blockers in patients with ankylosing spondylitis. - The Tap-AS study (tapering of TNF blockers in Ankylosing Spondylitis)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON46502
Enrollment
190
Registered
2017-09-12
Start date
2017-12-06
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

ankylosing spondylitis Bechterew's disease

Interventions

The tapering schedule consists of doubling the dosage interval of the TNFi. Patients that develop a flare will return to their original treatment schedule. In addition, a whole body dual-energy X-ra

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The number of patients (percentage men / women) that develop a flare within 1 year after tapering will be the primary outcome measure.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)