Optimizing treatment strategy in axial spondyloarthritis by molecular imaging with Technetium-labeled certolizumab pegol.
Key facts
- Where
- Gent, BelgiumSee the site
- Phase
- 3. fázis
Where in Belgium
- Universitair Ziekenhuis GentGent, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitair Ziekenhuis Gent
- Trial code
- EU 2023-505694-32-00
- Record updated
- 2026. augusztus 26.
- Original description
To determine that including immunoscintigraphy in the existing therapeutic decision algorithm for axSpA improves assessment of disease activity and prediction of response to treatment with immunomodulating agents at week 12 (±2) after treatment initiation.Read full original descriptionShow less
To determine that including immunoscintigraphy in the existing therapeutic decision algorithm for axSpA improves assessment of disease activity and prediction of response to treatment with immunomodulating agents at week 12 (±2) after treatment initiation.
Inclusion: 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: Any contraindications to starting therapy with a bDMARD or a tsDMARD; 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; 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); Latent or active tuberculosis or other severe infections such as sepsis or opportunistic infections; Known allergy to Certolizumab pegol or any of its excipients; 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; Lack of informed, written consent to participation in the study; Participation in another clinical study; Any contraindications to scintigraphy; Pregnancy or lactation, or refusal to perform a urine stick pregnancy test.