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UVB: treatment of UVeitis in Behçet’s diseases with biologic
EU CTIS ID: 2024-513371-41-00
What this study is testing
To assess the benefit of tocilizumab comparatively to that of adalimumab in sight-threatening Behçet’s disease uveitis at week 16.
- Therapeutic exploratory (Phase II)
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
- Age >= 18 at Inclusion
- Affiliation to a social security system. Patients affiliated to universal medical coverage (CMU) are eligible for the study
- Provide written, informed consent prior to the performance of any study-specific procedures
- Diagnosis of Behçet’s disease according to the International Criteria for Behçet's Disease (ICBD) (see appendix 18.2) or history of aphtosis
- Diagnosis of non-infectious intermediate, posterior-, or pan-uveitis in at least one eye fulfilling the International Study Group Classification Criteria (Standardization of Uveitis Nomenclature [SUN] criteria) of posterior, or pan- uveitis
- Sight threatening uveitis defined according to the validated international definition as 2 lines of drop in visual acuity on a 10/10 scale, and/or retinal inflammation (macular oedema and/or retinal vasculitis).
You likely can't join if
- Infectious uveitis, masquerade syndromes, or uveitis due to causes other than BD uveitis
- History of intestinal ulceration or diverticulitis
- Known porphyria
- Laboratory values assessed during Inclusion: a. Neutrophil < 1.0 x 10^3/mm3 ; b. Platelet count < 80x 10^3/mm3 ; c. ASAT or ALAT > 5 ULN
- Treatment with anti-TNF and/or Tocilizumab therapy within 1 month prior to inclusion
- Patient on azathioprine, mycophenolate mofetil, or methotrexate at the time of inclusion (these drugs must be withdrawn prior to receiving the tocilizumab or adalimumab dose on Day 0).
See the full eligibility criteria
Who can join
- Age >= 18 at Inclusion
- Affiliation to a social security system. Patients affiliated to universal medical coverage (CMU) are eligible for the study
- Provide written, informed consent prior to the performance of any study-specific procedures
- Diagnosis of Behçet’s disease according to the International Criteria for Behçet's Disease (ICBD) (see appendix 18.2) or history of aphtosis
- Diagnosis of non-infectious intermediate, posterior-, or pan-uveitis in at least one eye fulfilling the International Study Group Classification Criteria (Standardization of Uveitis Nomenclature [SUN] criteria) of posterior, or pan- uveitis
- Sight threatening uveitis defined according to the validated international definition as 2 lines of drop in visual acuity on a 10/10 scale, and/or retinal inflammation (macular oedema and/or retinal vasculitis).
- Chest X-ray (postero-anterior and lateral) or CT-scanner results within 12 weeks prior to Inclusion with no evidence of active Tuberculosis, active infection, or malignancy
- For female subjects of child-bearing potential (premenopausal female capable of becoming pregnant), a negative serum pregnancy test (plasmatic or urinary)
- For subjects with reproductive potential, a willingness to use contraceptive measures adequate to prevent the subject or the subject’s partner from becoming pregnant during the study and 3 and 5 months after stopping therapy for tocilizumab and adalimumab, respectively.
- Negative TB test obtained within 12 weeks prior to inclusion. A potential subject with a positive interferon-gamma release assay (IGRA) (e.g., QuantiFERON®-TB Gold or T-spot TB® Test) is eligible if her/his chest X-ray does not show evidence suggestive of active TB disease and there are no clinical signs and symptoms of pulmonary and/or UVB protocol, version 5.0 of 02/04/2024 31/76 This document is the property of DRCI/AP-HP. All reproduction is strictly prohibited extra-pulmonary TB disease. These subjects with a latent TB infection who have not already received a prophylactic TB treatment must agree in advance to complete such a treatment course. The treatment should be started at the latest at inclusion
What rules you out
- Infectious uveitis, masquerade syndromes, or uveitis due to causes other than BD uveitis
- History of intestinal ulceration or diverticulitis
- Known porphyria
- Laboratory values assessed during Inclusion: a. Neutrophil < 1.0 x 10^3/mm3 ; b. Platelet count < 80x 10^3/mm3 ; c. ASAT or ALAT > 5 ULN
- Treatment with anti-TNF and/or Tocilizumab therapy within 1 month prior to inclusion
- Patient on azathioprine, mycophenolate mofetil, or methotrexate at the time of inclusion (these drugs must be withdrawn prior to receiving the tocilizumab or adalimumab dose on Day 0).
- Stage III and IV New York Heart Association (NYHA) cardiac insufficiency
- Severe renal (Glomerular filtration rates (GFR) <30ml/min) or liver insufficiency (prothrombin <50% without other causes)
- Any live (attenuated) vaccine within 30 days prior to inclusion
- Breastfeeding and pregnant women
- Active tuberculosis or history of untreated tuberculosis and/or severe infection
- Positive HIV antibody and/or positive hepatitis B surface antigen and/or positive hepatitis C RNA, results obtained within 1 month prior to inclusion
- History of malignancy within 5 years prior to Inclusion other than carcinoma in situ of the cervix, non-metastatic squamous or basal cell carcinoma of the skin
- History of severe allergic or anaphylactic reactions to monoclonal antibodies
- History of multiple sclerosis and/or demyelinating disorder
- Hypersensitivity to the active substance or an excipient of the IMP or the auxiliary medicine
- Active or suspected ocular infection
- Infection oculaire active suspectée
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, 65+ years, 18-64 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.