Impact of ankylosing spondylitis (AS) on social participation and reversibility by anti-TNF-a (adalimumab) therapy
- Conditions
- 10024450Ankylosing Spondylitis10023213
- Registration Number
- NL-OMON38200
- Lead Sponsor
- niversiteit Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 80
- 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.
- 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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>A decrease in importance satisfaction gap of social participation areas over<br /><br>time in AS patients, due to a decrease of the disease burden, caused by<br /><br>treatment with anti-TNF-a (adalimumab)</p><br>
- Secondary Outcome Measures
Name Time Method <p>(2) Understand which disease related and which contextual factors contribute to<br /><br>the change in restrictions of participation and in the gap between importance<br /><br>and satisfaction in participation areas. Several new variables will be<br /><br>assessed, such as: objectively assessed physical activity, body composition,<br /><br>beliefs/attitude regarding physical activity. (3) Changes in physical activity<br /><br>and body composition. Furthermore (4), the relation of participation and<br /><br>satisfaction with life is an important secondary parameter. </p><br>