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Taking people in BelgiumPhase 3

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
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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data 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