BridgeMD
Evaluation of a therapeutic de-eScalation strategy based on therapeutic drug MOnitOring in chronic non-infectious uveitis Treated witH adalimumab
EU CTIS ID: 2023-509733-39-00
What this study is testing
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).
- Therapeutic use (Phase IV)
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
- Is a member or beneficiary of a social security scheme
- Having received informed information about the study and having co-signed, with the investigator, a consent to participate in the study
- Adult (age ≥ 18 years)
- Patient with a diagnosis of chronic non-infectious uveitis in at least one eye and meeting the Standardization of Uveitis Nomenclature (SUN) criteria
- Patient with a complete ophthalmological response for ≥ 48 weeks (96 weeks for uveitis related to Behçet's disease), all treatments combined
- Patient on ADA 40mg / 14 days for ≥ 24 weeks (allowing steady state)
You likely can't join if
- Inability or refusal to understand and/or sign the informed consent to participate in the study.
- Inability and/or refusal to carry out the follow-up examinations required for the study
- Modification of any background immunomodulatory treatment (e.g. methotrexate, hydroxychloroquine, mycophenolate, etc.) associated with ADA, during the 12 weeks prior to inclusion
- Uveitis suspected or proven to be of infectious origin
- Planned surgery (or other foreseeable medical event) requiring discontinuation of ADA for the duration of the study
See the full eligibility criteria
- Is a member or beneficiary of a social security scheme
- Having received informed information about the study and having co-signed, with the investigator, a consent to participate in the study
- Adult (age ≥ 18 years)
- Patient with a diagnosis of chronic non-infectious uveitis in at least one eye and meeting the Standardization of Uveitis Nomenclature (SUN) criteria
- Patient with a complete ophthalmological response for ≥ 48 weeks (96 weeks for uveitis related to Behçet's disease), all treatments combined
- Patient on ADA 40mg / 14 days for ≥ 24 weeks (allowing steady state)
- Patient not having received systemic corticosteroid therapy for ≥ 12 weeks
- Inability or refusal to understand and/or sign the informed consent to participate in the study.
- Inability and/or refusal to carry out the follow-up examinations required for the study
- Modification of any background immunomodulatory treatment (e.g. methotrexate, hydroxychloroquine, mycophenolate, etc.) associated with ADA, during the 12 weeks prior to inclusion
- Uveitis suspected or proven to be of infectious origin
- Planned surgery (or other foreseeable medical event) requiring discontinuation of ADA for the duration of the study
The study team makes the final eligibility decision.
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 - 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.