Optimizing treatment strategy in axial spondyloarthritis by molecular imaging with Technetium-labeled certolizumab pegol.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitair Ziekenhuis Gent

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05], Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

29 Aug 2024 → ongoing

Decision date (initial)

2024-01-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Ghent University Hospital

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

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.

Secondary objectives 5

1. Assessment of the predictive value of immunoscintigraphy in predicting response to treatment with immunomodulating agents at week 24 (±2) after treatment initiation
2. Assessment of the correlation between magnetic resonance imaging and immunoscintigraphy results at baseline.
3. Assessment of the difference in diagnostic certainty of active disease assessment based on the existing decision algorithm versus an algorithm including immunoscintigraphy
4. Assessment of the 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 week 12 (±2) and week 24 (±2) after treatment initiation
5. Exploratory objectives will be to perform cost effectiveness evaluation and budget impact analysis of including immunoscintigraphy in the existing therapeutic decision algorithm for axSpA.

Conditions and MedDRA coding

Axial Spondyloarthritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

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

Exclusion criteria 13

1. Lack of informed, written consent to participation in the study
2. 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
3. Participation in another clinical study
4. Any contraindications to scintigraphy
5. Latent or active tuberculosis or other severe infections such as sepsis or opportunistic infections
6. Known allergy to Certolizumab pegol or any of its excipients
7. Pregnancy or lactation, or refusal to perform a urine stick pregnancy test;
8. 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.
9. Patient may not have received treatment with a bDMARD or tsDMARD in 3 months preceding study inclusion
10. Any contraindications to starting therapy with a bDMARD or a tsDMARD
11. Documented diagnosis of immune-mediated inflammatory diseases other than axial spondyloarthritis, which may conceal the result of immunoscintigraphy
12. Severe renal impairment
13. Moderate to severe heart failure (NYHA classes III/IV)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 5

1. 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.
2. Difference in diagnostic certainty of active disease assessment based on the existing decision algorithm versus an algorithm including immunoscintigraphy.
3. Correlation between magnetic resonance imaging and immunoscintigraphy results at baseline when the immunoscintigraphy will be performed.
4. 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.
5. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Ziekenhuis Gent

Sponsor organisation

Universitair Ziekenhuis Gent

Address

Corneel Heymanslaan 10

City

Gent

Postcode

9000

Country

Belgium

Scientific contact point

Organisation

Universitair Ziekenhuis Gent

Contact name

Anuschka Van Den Bogaert

Public contact point

Organisation

Universitair Ziekenhuis Gent

Contact name

Anuschka Van Den Bogaert

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

4 submissions — initial application plus substantial / non-substantial modifications