Optimizing treatment strategy in axial spondyloarthritis by molecular imaging with Technetium-labeled certolizumab pegol. - SCINTRA-3

niversitair Ziekenhuis Gent0 个研究点目标入组 78 人开始时间: 2023年10月16日最近更新: 2024年7月22日

适应症

试验速览

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•Patient's informed, written consent to participate, Male patients whose partners may become pregnant should be surgically sterile or use a condom during intercourse until 35 days after the last scan., Age above 18 years old up to 85 years old, Documented diagnosis of axial spondyloarthritis fulfilling ASAS classification criteria, Conform with the Belgian reimbursement criteria for starting a bDMARD or tsDMARD for axial spondyloarthritis, Shared decision of the study participant - the patient - and the treating rheumatologist, to start therapy with a bDMARD or a tsDMARD, MRI is performed not longer than 3 months prior to the screening visit., CRP level >5mg/L (Assessment of CRP levels not longer than 3 months prior to the screening visit), Documented insufficient response to treatment with first line medication, i.e. 2 NSAIDs in optimal dose, Female patients should be either post-menopausal, surgically sterile, or using highly effective contraceptives

•Lack of informed, written consent to participation in the study, Any contraindications to starting therapy with a bDMARD or a tsDMARD, Documented diagnosis of immune-mediated inflammatory diseases other than axial spondyloarthritis, which may conceal the result of immunoscintigraphy, Severe renal impairment, Moderate to severe heart failure (NYHA classes III/IV), Lack of results of laboratory tests (or results older than 3 months prior to the study inclusion): CRP, ESR, complete blood count, serum creatinine, eGFR, AST, ALT, GGT, HBV, HBC, HIV, Participation in another clinical study, Any contraindications to scintigraphy, Latent or active tuberculosis or other severe infections such as sepsis or opportunistic infections, Known allergy to Certolizumab pegol or any of its excipients, Pregnancy or lactation, or refusal to perform a urine stick pregnancy test;, Patient may not have received any experimental biological and/or non-biological therapy in 3 months preceding study inclusion, or 5 times the half-life of the administered mediation before inclusion in the study., Patient may not have received treatment with a bDMARD or tsDMARD in 3 months preceding study inclusion

发起方

niversitair Ziekenhuis Gent