Optimizing treatment strategy in axial spondyloarthritis by molecular imaging with Technetium-labeled certolizumab pegol.
EU CTIS ID: 2023-505694-32-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.