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

Academisch Medisch Centrum0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•-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.

•-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.

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