Using a special scan to guide treatment in axial spondyloarthritis
Tests whether a special imaging scan helps choose treatment for adults with axial spondyloarthritis.
Key facts
- Who runs it
- Universitair Ziekenhuis Gent
- Where
- Gent, BelgiumSee the site
- Trial code
- Registry title
- Optimizing treatment strategy in axial spondyloarthritis by molecular imaging with Technetium-labeled certolizumab pegol.
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 78 people, planned
- Started
- 29 Aug 2024
- Expected to end
- 30 Jun 2028
- Type of study
- Interventional
- Record updated
- 26 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with axial spondyloarthritis who did not improve enough on 2 NSAIDs and are about to start a bDMARD or tsDMARD, to test a scan with Technetium-labeled certolizumab pegol.
- Age
- Above 18 years old up to 85 years old
- Sex
- All
- Disease stage
- Documented axial spondyloarthritis meeting ASAS classification criteria, meeting Belgian reimbursement criteria for starting a bDMARD or tsDMARD, CRP above 5mg/L, and an MRI done within 3 months before screening.
- Earlier treatment
- Insufficient response to first-line treatment with 2 NSAIDs in optimal dose. No bDMARD or tsDMARD in the 3 months before joining.
- Biomarker or test result
- CRP level above 5mg/L, measured within 3 months before screening.
Main reasons for not taking part
- Another immune-mediated inflammatory disease that may hide the scan result
- Severe kidney problems or moderate to severe heart failure (NYHA III/IV)
- Latent or active tuberculosis or other severe infection
- Known allergy to certolizumab pegol or its excipients
- Pregnancy or breastfeeding
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Belgium
- Universitair Ziekenhuis GentGent, BelgiumTaking people
About the trial
What the trial wants to find out
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.
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- Optimizing treatment strategy in axial spondyloarthritis by molecular imaging with Technetium-labeled certolizumab pegol.
- Plain-language title
- Using a special scan to guide treatment in axial spondyloarthritisGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 26 August 2026