Evidence-Based Mindset & Physical Therapy for Add-on Treatment of Active Axial Spondyloarthritis: Safety and Efficacy

Completed

• Conditions: Axial Spondyloarthritis; Bechterew; 10003816; 10023213

• Registration Number: NL-OMON43901
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

-Clinical diagnosis of axSpA as assessed by the treating rheumatologist fulfilling the ASAS classification for axial SpA [Rudwaleit 2009]
-Between 18 and 55 years of age at screening
-Active disease as defined by an Ankylosing Spondylitis Disease Activity Score (ASDAS) of >2.1 and a CRP value of *5 at the screening visit.
-Ability and willingness to participate to the study and give written informed consent.

Exclusion Criteria

-Patients who cannot give written consent or, in the opinion of the investigator, cannot comply to the requirements of the study protocol. Significant comorbidity, including a cardiac, renal, hepatic, neurological, metabolic or any other severe disease, which in the opinion of the investigator may interfere with the study or lead to deleterious effects for the patient.
-Recent history of (or persistent) infection requiring hospitalization or antibiotic treatment within 4 weeks of baseline.
-If female, patient should not be pregnant. A urine pregnancy-test will be performed at screening and has to be negative.
-Initiation of treatment with corticosteroids or DMARDs (synthetic and biologic) within 8 weeks before screening.
-Initiation of treatment with NSAID within 2 weeks before screening.
-Variation of the treatment doses within 6 weeks of screening.
-Intra-articular injection with corticosteroids within 4 weeks prior to screening.
-Daily doses of systemic corticosteroids exceeding the equivalent of 10 mg prednisolone per day.
-Use of other drugs and treatments that may affect the evaluation of systemic inflammation as judged by the investigator.
-Cardiovascular risk factors such as a personal history of cardiovascular disease, familial history of major adverse cardiovascular events (MACE) at age younger than 55 yrs, hypercholesterolemia and stroke.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety evaluation of the program is the primary aim of the study, and<br /><br>therefore, the primary outcome measure is chosen to detect changes at the level<br /><br>of severity of the axial spondyloarthritis (axSpA) using clinical parameters.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Difference in CRP between baseline and week 8<br /><br>- Difference in circulating cytokines between baseline and week 8<br /><br>- Change in Ankylosing Spondylitis Disease Activity Score (ASDAS)<br /><br>- Change in other serum inflammation biomarkers (ESR, calprotectin)<br /><br>- Change in quality of life as measured by the SF-36, the EQ-5D<br /><br>- Change in depressive symptoms as measured by the Beck Depression Inventory<br /><br>(BDI-II)<br /><br>- Predictive role of generalized and specific outcome expectancies (EPQ-N,<br /><br>LOT-R, VAS scales)</p><br>