TECHNETIUM (99MTC) CERTOLIZUMAB PEGOL for Axial spondyloarthritis

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"-Lack of informed, written consent to participation in the study"}
• {"criterion_text":"-Any contraindications to starting therapy with a bDMARD or a tsDMARD"}
• {"criterion_text":"-Documented diagnosis of immune-mediated inflammatory diseases other than axial spondyloarthritis, which may conceal the result of immunoscintigraphy"}
• {"criterion_text":"-Severe renal impairment"}
• {"criterion_text":"-Moderate to severe heart failure (NYHA classes III/IV)"}
• {"criterion_text":"-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"}
• {"criterion_text":"-Participation in another clinical study"}
• {"criterion_text":"-Any contraindications to scintigraphy"}
• {"criterion_text":"-Latent or active tuberculosis or other severe infections such as sepsis or opportunistic infections"}
• {"criterion_text":"-Known allergy to Certolizumab pegol or any of its excipients"}
• {"criterion_text":"-Pregnancy or lactation, or refusal to perform a urine stick pregnancy test;"}
• {"criterion_text":"-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."}
• {"criterion_text":"-Patient may not have received treatment with a bDMARD or tsDMARD in 3 months preceding study inclusion"}

Primary endpoints

• {"endpoint_text":"-Difference in response rates (defined as ASDAS (Ankylosing Spondylitis Disease Activity Score) clinically important improvement) to immunomodulating (bDMARDs and tsDMARDs) agents between screening and 12 (±2) weeks after treatment initiation between patients with positive and negative immunoscintigraphy. Response is based on changes in disease activity scores.","definition_or_measurement_approach":"Defined as ASDAS clinically important improvement; response based on changes in disease activity scores measured at 12 (±2) weeks after treatment initiation."}

Secondary endpoints

• {"endpoint_text":"-Difference in response rates (defined as ASDAS clinically important improvement and Assessment of Spondyloarthritis international Society 40 response (ASAS 40 response)) to immunomodulating agents between screening and after week 24 (±2) weeks after treatment initiation between patients with positive and negative immunoscintigraphy.","definition_or_measurement_approach":"Defined as ASDAS clinically important improvement and ASAS40 response; measured at 24 (±2) weeks after treatment initiation."}
• {"endpoint_text":"-Difference in diagnostic certainty of active disease assessment based on the existing decision algorithm versus an algorithm including immunoscintigraphy.","definition_or_measurement_approach":"Comparison of diagnostic certainty between existing algorithm and algorithm including immunoscintigraphy (method of assessing 'diagnostic certainty' not further specified)."}
• {"endpoint_text":"-Correlation between magnetic resonance imaging and immunoscintigraphy results at baseline when the immunoscintigraphy will be performed.","definition_or_measurement_approach":"Correlation analysis between MRI and immunoscintigraphy results at baseline."}
• {"endpoint_text":"-Evolution of patient reported outcomes (PROs), collected in the form of standardized questionnaires, used in routine clinical practice, and laboratory markers of inflammation (serum levels of CRP and ESR), tested in routine clinical practice, from baseline up to 12 (±2) and 24 (±2) weeks after treatment initiation.","definition_or_measurement_approach":"Assessment of PROs via standardized questionnaires and laboratory markers (CRP, ESR) longitudinally at baseline, 12 (±2) and 24 (±2) weeks."}
• {"endpoint_text":"-Exploratory trial endpoints: The costs of quality-adjusted life-year and impact on treatment budget will be assessed in all included patients by standardized questionnaires.","definition_or_measurement_approach":"Health economic evaluation assessing cost per QALY and budget impact using standardized questionnaires."}

Belgium

Earliest CTIS Part Ii Submission Date

12-12-2023

Latest Decision Or Authorization Date

15-05-2024

Processing Time Days

155

Number Of Sites

1

Number Of Participants

78

Primary sponsor

Full Name

Universitair Ziekenhuis Gent

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium