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

Phase 1

• Conditions: Axial Spondyloarthritis; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: CTIS2023-505694-32-00
• Lead Sponsor: niversitair Ziekenhuis Gent

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-16
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified