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Impact of ankylosing spondylitis (AS) on social participation and reversibility by anti-TNF-a (adalimumab) therapy

Impact of ankylosing spondylitis (AS) on social participation and reversibility by anti-TNF-a (adalimumab) therapy - AS participation study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON38200
Enrollment
80
Registered
2011-09-14
Start date
2012-03-19
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Ankylosing Spondylitis

Interventions

None listed

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Have AS according to the New York criteria - Be under the care of a rheumatologist - Start TNF inhibitors (adalimumab) as being part of current practice - BASDAI score of 4 or higher. - All subjects must be recruited within a period of 1 (one) year from the start of the longitudinal study.

Exclusion criteria

Exclusion criteria: - Have severe non-AS related co morbidity according to the diagnose treatment combination (DBC). Please note that this only applies for patients with a co-morbidity, by whom the treating doctor/rheumatologist decides they should not be included in the study because of health reasons. Patients who suffer from a co-morbidity without a non-immediate health risk will be included. Their situation will be assesses with the SQC questionnaire in order to correct for a confounding effect. - Have contra-indications (diagnosed by treating rheumatologist/specialist) for TNF inhibition - Do not understand the Dutch language - Do not have access to a computer with internet

Design outcomes

Primary

MeasureTime frame
A decrease in importance satisfaction gap of social participation areas over time in AS patients, due to a decrease of the disease burden, caused by treatment with anti-TNF-a (adalimumab)

Secondary

MeasureTime frame
(2) Understand which disease related and which contextual factors contribute to the change in restrictions of participation and in the gap between importance and satisfaction in participation areas. Several new variables will be assessed, such as: objectively assessed physical activity, body composition, beliefs/attitude regarding physical activity. (3) Changes in physical activity and body composition. Furthermore (4), the relation of participation and satisfaction with life is an important secondary parameter.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)