ClinicalTrials.gov record NCT05874505
"Comparison of the Efficacy and Safety of Adalimumab to That of Tocilizumab in Severe Uveitis of Behçet's Disease"
"Multicenter, Randomized, Prospective Trial Comparing the Efficacy and Safety of Adalimumab to That of Tocilizumab in Severe Uveitis of Behçet's Disease" (UVB) : Treatment of UVeitis in Behçet's Diseases With Biologics
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is a randomized, open-label Phase 2 trial that compares two injectable biologic drugs, adalimumab and tocilizumab, as treatments for sight‑threatening uveitis caused by Behcet's disease. Adults with non-infectious intermediate, posterior, or panuveitis judged sight‑threatening are the target population. The main outcome is complete control of ocular inflammation on a low dose of prednisone at week 16, with additional follow-up for measures of inflammation, vision, steroid use, relapses, and safety up to 48 weeks.
What it is studying. The study tests and compares the efficacy and safety of adalimumab versus tocilizumab for achieving complete remission of ocular involvement in sight‑threatening Behcet's uveitis, assessed at week 16.
What the researchers hope to learn. To determine which of the two drugs better controls ocular inflammation in sight‑threatening Behcet's uveitis at week 16 and to compare safety profiles. Secondary goals include measuring steroid-sparing effects, time to response, relapse rates, visual acuity, retinal thickness, inflammation markers, quality of life scores, and adverse event frequency and severity up to 48 weeks.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
UVB, is the first randomized prospective, head to head study, comparing Adalimumab to Tocilizumab in sight threatening uveitis of Behçet's Disease (BD). Anti-TNFα has been used for BD uveitis for 15 years. The incidence of blindness in BD has been dramatically reduced in the recent years with the use of biologics. There is no firm evidence or randomized controlled trials directly addressing the best induction therapy in severe BD uveitis. BD uveitis is considered as the most devastating inflammatory ocular disease. Risk of visual loss reaches 25% at 5 years and 80% of patients have a bilateral involvement. Contrasting with immunosuppressors or interferon-alpha, biotherapies act rapidly and are highly effective in steroid's sparing thus preventing occurrence of cataract and/or glaucoma. However, anti-TNFα failed to demonstrate sustainable complete remission over 50 % of severe sight threatening uveitis. There is little published information on use of biologics other than anti-TNFα for severe BD uveitis. Tocilizumab has been used with success in severe and/or resistant cases and is one of the most promising biologics in BD. IL-6 expression correlates with BD activity and other immunological data provide a strong rationale for targeting BD with tocilizumab. Despite a strong rationale, these compounds are not yet approved in BD, which guarantees the innovative nature of this study that aims selecting or dropping any arm when evidence of efficacy already exists. The objective of the study is to assess the benefit of tocilizumab comparatively to that of adalimumab in sight-threatening Behçet's disease uveitis at week 16
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Adalimumab
- Tocilizumab
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Age >= 18 at Inclusion
- 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) or history of aphthosis.
- 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 childbearing 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. Birth control methods which may be considered as highly effective methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods (according to CTFG recommendations). Such methods include:
- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- oral
- intravaginal
- transdermal
- progestogen-only hormonal contraception associated with inhibition of ovulation:
- oral
- injectable
- implantable
- intrauterine device (IUD)
- intrauterine hormone-releasing system (IUS)
- bilateral tubal occlusion
- vasectomised partner
- sexual abstinence (In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject).
- For male subjects :
- use of a condom
- vasectomy (with documentation of azoospermia)
- sexual abstinence
- A potential subject with a positive interferon-gamma release assay (IGRA) (e.g., QuantiFERON®-TB Gold or T-spot TB® Test) obtained within 6 months prior to inclusion 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 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.
- Affiliation to a social security system. Patients affiliated to universal medical coverage (CMU) are eligible for the study
Exclusion criteria
- Infectious uveitis, masquerade syndromes, or uveitis due to causes other than BD uveitis
- 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 or adequately treated, 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 Investigational Medicinal Product or the auxiliary medicine
- Active or suspected ocular infection
- Active or suspected systemic infection
- History of intestinal ulceration or diverticulitis
- Known porphyria
- Laboratory values assessed during Inclusion:
- Neutrophil < 1.0 x 10\^3 /mm3
- Platelet count < 80 x 10\^3 /mm3
- ASAT or ALAT > 5 ULN
- Treatment with anti-TNF and/or Tocilizumab therapy within 1 month prior to inclusion
- if 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 4 weeks prior to inclusion
- Breastfeeding or pregnant women
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
If enrolled you will be randomly assigned to receive either subcutaneous adalimumab (loading dose then repeated injections up to week 15) or weekly subcutaneous tocilizumab for 15 weeks. Expect regular eye exams, vision testing, retinal imaging (OCT and, if indicated, angiography), blood tests (inflammation markers and safety labs), and clinic visits with monitoring for adverse events up to 48 weeks. Women of childbearing potential will have pregnancy tests and all participants with reproductive potential must follow contraception requirements; those with latent TB may need to start TB prophylaxis before or at inclusion. If you are taking azathioprine, mycophenolate or methotrexate these must be stopped before receiving the first study dose.
How the study is structured. A randomized, open-label (no masking), parallel-group Phase 2 drug trial. Participants are assigned to receive either subcutaneous adalimumab doses over 15 weeks or weekly subcutaneous tocilizumab for 15 weeks. Disease activity, steroid use, vision measures, inflammatory markers, relapses, and adverse events are recorded over visits through week 48.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- No sites are listed on the registry yet. Where will the study take place?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Behçet's disease
Important dates
- Study start
- July 2023 (estimated)
- Primary completion
- November 2026 (estimated)
- Study completion
- July 2027 (estimated)
- Target enrollment
- 60 participants (estimated)
- Last updated on registry
- May 25, 2023
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Bahram BODAGHI, Pr 📞 +33 1 42 16 37 28 ✉ bahram.bodaghi@aphp.fr
- Matthieu RESCHE-RIGON, Pr 📞 +33 1 42 49 97 42 ✉ matthieu.resche-rigon@u-paris.fr
Participating sites
Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.
Terms used on this page · explanations by MedicalUpdates.ai
- randomized
- Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
- complete remission
- No sign of the condition can be found with the tests used in the study. It does not always mean the condition is gone permanently, and the definition depends on the condition and the study.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Study Group
- One of the groups in a study. Each arm receives a particular intervention, comparator or no intervention, so the groups can be compared.
- CT
- An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
- childbearing potential
- Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
- Investigational
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- ULN
- The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
- GFR
- A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
← Back to clinical trials