Evaluation of a therapeutic de-eScalation strategy based on therapeutic drug MOnitOring in chronic non-infectious uveitis Treated witH adalimumab

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Saint Etienne

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Decision date (initial)

2025-02-13

Transition trial

No

Low-intervention

Yes

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

French Ministry of health

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Efficacy

To demonstrate the superiority of ADA spacing based on TDM, compared to a conventional ADA-based therapeutic strategy in patients with NICU who have achieved complete response, in terms of net clinical benefit (maintenance of complete ophthalmological response and absence of infection) at 48 weeks (W48).

Secondary objectives 5

1. To evaluate, in patients with chronic non-infectious uveitis in complete response, the impact of a CT-based ADA treatment spacing strategy, compared with the conventional treatment strategy, on the net clinical benefit at S12, S24 and S36.
2. To evaluate, in patients with chronic non-infectious uveitis in complete response, the impact of a strategy of therapeutic spacing of ADA based on the duration before ophthalmological relapse and/or the occurrence of an infection.
3. To evaluate, in patients with chronic non-infectious uveitis in complete response, the impact of a strategy of therapeutic spacing of ADA based on the rate of anti-ADA immunisation at S0, S12, S24, S36 and S48.
4. Evaluate, in patients with chronic non-infectious uveitis in complete response, the impact of a strategy of therapeutic spacing of ADA based on patients' quality of life.
5. Evaluating the impact of a strategy of spacing out ADA therapy in patients with chronic non-infectious uveitis who have responded completely, based on the medico-economic consequences in terms of cost-effectiveness for society.

Conditions and MedDRA coding

noninfectious uveitis

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Is a member or beneficiary of a social security scheme
2. Having received informed information about the study and having co-signed, with the investigator, a consent to participate in the study
3. Adult (age ≥ 18 years)
4. Patient with a diagnosis of chronic non-infectious uveitis in at least one eye and meeting the Standardization of Uveitis Nomenclature (SUN) criteria
5. Patient with a complete ophthalmological response for ≥ 48 weeks (96 weeks for uveitis related to Behçet's disease), all treatments combined
6. Patient on ADA 40mg / 14 days for ≥ 24 weeks (allowing steady state)
7. Patient not having received systemic corticosteroid therapy for ≥ 12 weeks

Exclusion criteria 5

1. Inability or refusal to understand and/or sign the informed consent to participate in the study.
2. Inability and/or refusal to carry out the follow-up examinations required for the study
3. Modification of any background immunomodulatory treatment (e.g. methotrexate, hydroxychloroquine, mycophenolate, etc.) associated with ADA, during the 12 weeks prior to inclusion
4. Uveitis suspected or proven to be of infectious origin
5. Planned surgery (or other foreseeable medical event) requiring discontinuation of ADA for the duration of the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is a composite of : - Maintenance of complete ophthalmological response at W48 Complete ophthalmological response being defined as the combination, in both eyes, of: absence of inflammatory lesions AND a cellular grade of the anterior chamber and vitreous ≤ 0.5+. - The absence of infection during follow-up for up to 48 weeks.

Secondary endpoints 5

1. Maintenance of complete ophthalmological response and absence of infection as defined in the primary endpoint section at W12, W24 and W36.
2. Occurrence of a relapse, defined by the presence of any inflammatory lesion and a cellular grade of the anterior chamber and vitreous >0.5+ and/or the occurrence of an infection up to 48 weeks, collected on dedicated forms, notified and validated by the adjudication committee.
3. Anti-ADA antibody positivity and titers at W0, W12, W24, W36 and W48 using a "drug-sensitive" test (i-Tracker anti-ADA) and a "drug-tolerant" test (allowing the absence of false negatives due to the formation of ADA-anti-ADA complexes).
4. Measurement of quality of life using the National Eye Institute Visual Functioning Questionaire-25 (NEI VFQ-25) composite score at W0, W12, W24, W36 and W48.
5. Incremental cost-effectiveness ratio (ICER)

Investigational products

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

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Saint Etienne

Sponsor organisation

Centre Hospitalier Universitaire De Saint Etienne

Address

Avenue Albert Raimond

City

Saint Priest En Jarez

Postcode

42270

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Saint Etienne

Contact name

Projet manager

Public contact point

Organisation

Centre Hospitalier Universitaire De Saint Etienne

Contact name

Projet manager

Locations

1 EU/EEA country · 10 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

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