Behcet's UveitisPhase 2UVBNCT05874505
"Comparison of the Efficacy and Safety of Adalimumab to That of Tocilizumab in Severe Uveitis of Behçet's Disease"
A Phase 2 study testing Adalimumab and Tocilizumab in people with Behcet's Uveitis, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Behcet's Uveitis
- What is being tested?
- Adalimumab and Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: "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
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
- Conditions
- Behcet's Uveitis
- Being tested
- Adalimumab, Tocilizumab
- Keywords
- Biologics, Adalimumab, Tocilizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Adalimumab 80 mg at Day 0 then 40 mg subcutaneous at week 1, 3, 5, 7, 9, 11, 13 and 15
TocilizumabDrug
Tocilizumab 162 mg subcutaneous each week for 15 weeks
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab | Experimental | Adalimumab 80 mg at Day 0 then 40 mg subcutaneous at week 1, 3, 5, 7, 9, 11, 13 and 15 Receives: Drug: Adalimumab |
| Tocilizumab | Experimental | Tocilizumab 162 mg subcutaneous each week for 15 weeks Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with complete remission of ocular involvement (Efficacy)
Efficacy will be defined by a complete remission of ocular involvement with prednisone lower or equal to 5 mg/day . Ocular involvement response to treatment will be evaluated according to the Standardization of Uveitis Nomenclature (SUN) Workgroup criteria.
Measured: At week 16 after randomization
Secondary outcomes (85)
Percent of patients meeting the corticosteroid sparing targets
lower than 0.1 mg/day/kg of prednisone
Measured: At week 16 after randomization
Mean dose of corticosteroids
Measured: At week 16 after randomization
Cumulative dose of corticosteroids
Measured: At week 16 after randomization
Time to response onset
Measured: Up to week 48
Erythrocyte sedimentation rate
Measured: At week 4
Erythrocyte sedimentation rate
Measured: At week 8
Erythrocyte sedimentation rate
Measured: At week 12
Erythrocyte sedimentation rate
Measured: At week 16
Erythrocyte sedimentation rate
Measured: At week 24
Erythrocyte sedimentation rate
Measured: At week 36
Erythrocyte sedimentation rate
Measured: At week 48
C-reactive protein rate
Measured: At week 4
C-reactive protein rate
Measured: At week 8
C-reactive protein rate
Measured: At week 12
C-reactive protein rate
Measured: At week 16
C-reactive protein rate
Measured: At week 24
C-reactive protein rate
Measured: At week 36
C-reactive protein rate
Measured: At week 48
Rate of relapses
Relapse will be defined as the reappearance of clinical and/or paraclinical features of active disease or by the occurrence of new lesions or progression of preexisting lesions
Measured: up to 48 weeks
Time to occurrence of relapse or worsening of uveitis
Relapse will be defined as the reappearance of clinical and/or paraclinical features of active disease or by the occurrence of new lesions or progression of preexisting lesions
Measured: up to 48 weeks
Disease activity assessed by Behcet's Disease Current Activity
Changes in Behcet's Disease Current Activity Form 2006 The score varies between 0 and 12, the higher the score the higher the disease activity.
Lawton G, Bhakta BB, Chamberlain MA, Tennant A. The Behcet's disease activity index. Rheumatology (Oxford). 2004 Jan;43(1):73-8. doi: 10.1093/rheumatology/keg453. Epub 2003 Jul 30. PMID: 12890862.
Measured: At week 8
Disease activity assessed by Behcet's Disease Current Activity
Changes in Behcet's Disease Current Activity Form 2006 The score varies between 0 and 12, the higher the score the higher the disease activity.
Lawton G, Bhakta BB, Chamberlain MA, Tennant A. The Behcet's disease activity index. Rheumatology (Oxford). 2004 Jan;43(1):73-8. doi: 10.1093/rheumatology/keg453. Epub 2003 Jul 30. PMID: 12890862.
Measured: At week 16
Disease activity assessed by Behcet's Disease Current Activity
Changes in Behcet's Disease Current Activity Form 2006 The score varies between 0 and 12, the higher the score the higher the disease activity.
Lawton G, Bhakta BB, Chamberlain MA, Tennant A. The Behcet's disease activity index. Rheumatology (Oxford). 2004 Jan;43(1):73-8. doi: 10.1093/rheumatology/keg453. Epub 2003 Jul 30. PMID: 12890862.
Measured: At week 24
Disease activity assessed by Behcet's Syndrome Activity Score
Changes in Behcet's Syndrome Activity Score. It is a 10 items score. The score varies between 0 and 100. The higher the score the higher the disease activity.
Forbees C, Swearingen C, Yazici Y. Behcet's syndrome activity score (BSAS): a new disease activity assessment tool, composed of patient-derived measures only, is strongly correlated with the Behcet's Disease Current Activity Form (BDCAF) Arthritis Rheum. 2008;58(Suppl 9):S854-S855.
Measured: At week 8
Disease activity assessed by Behcet's Syndrome Activity Score
Changes in Behcet's Syndrome Activity Score. It is a 10 items score. The score varies between 0 and 100. The higher the score the higher the disease activity.
Forbees C, Swearingen C, Yazici Y. Behcet's syndrome activity score (BSAS): a new disease activity assessment tool, composed of patient-derived measures only, is strongly correlated with the Behcet's Disease Current Activity Form (BDCAF) Arthritis Rheum. 2008;58(Suppl 9):S854-S855.
Measured: At week 16
Disease activity assessed by Behcet's Syndrome Activity Score
Changes in Behcet's Syndrome Activity Score It is a 10 items score. The score varies between 0 and 100. The higher the score the higher the disease activity.
Forbees C, Swearingen C, Yazici Y. Behcet's syndrome activity score (BSAS): a new disease activity assessment tool, composed of patient-derived measures only, is strongly correlated with the Behcet's Disease Current Activity Form (BDCAF) Arthritis Rheum. 2008;58(Suppl 9):S854-S855.
Measured: week 24
Changes in the number of other organs involved by Behcet Disease (BD)
Measured: At week 4
Changes in the number of other organs involved by Behcet Disease (BD)
Measured: At week 8
Changes in the number of other organs involved by Behcet Disease (BD)
Measured: At week 12
Changes in the number of other organs involved by Behcet Disease (BD)
Measured: At week 16
Changes in the number of other organs involved by Behcet Disease (BD)
Measured: At week 24
Changes in the number of other organs involved by Behcet Disease (BD)
Measured: At week 36
Changes in the number of other organs involved by Behcet Disease (BD)
Measured: At week 48
Quality of Life assessed by Behcet's Disease Quality of Life Measure
It is a score composed of 30 items and the result varies between 0 and 30. The higher the score, the lower the quality of life.
- Gilworth, MA Chamberlain, B. Bhakta, A. Silman, D. Haskard and A. Tennant. (2004), The Development of the BD-Qol: A Quality of Life Instrument Specific to Behçet's Disease., J Rheum, 31, 931-7
Measured: At week 16
Quality of Life assessed by Behcet's Disease Quality of Life Measure
It is a score composed of 30 items and the result varies between 0 and 30. The higher the score, the lower the quality of life.
- Gilworth, MA Chamberlain, B. Bhakta, A. Silman, D. Haskard and A. Tennant. (2004), The Development of the BD-Qol: A Quality of Life Instrument Specific to Behçet's Disease., J Rheum, 31, 931-7
Measured: At week 24
Changes in Short Form (36) Health Survey for quality of life
The Short Form (36) Health Survey is a 36-item measure if health status. The score obtained varies between 0 and 100. The higher the score the less disability.
Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Med Care 1992;30:473-83.
Measured: At week 16
Changes in Short Form (36) Health Survey for quality of life
The Short Form (36) Health Survey is a 36-item measure if health status. The score obtained varies between 0 and 100. The higher the score the less disability.
Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Med Care 1992;30:473-83.
Measured: At week 24
Proportion of patients with adverse clinical events
Measured: at week 4
Proportion of patients with adverse clinical events
Measured: at week 8
Proportion of patients with adverse clinical events
Measured: at week 12
Proportion of patients with adverse clinical events
Measured: at week 16
Proportion of patients with adverse clinical events
Measured: at week 24
Proportion of patients with adverse clinical events
Measured: at week 36
Proportion of patients with adverse clinical events
Measured: at week 48
Severity of adverse clinical events
It is determined according to the Common Terminology Criteria for Adverse Events (CTCAE). The grade varies from 1 to 5. Grade 1 corresponds to mild severity and grade 5 to death.
Measured: At week 4
Severity of adverse clinical events
It is determined according to the Common Terminology Criteria for Adverse Events (CTCAE). The grade varies from 1 to 5. Grade 1 corresponds to mild severity and grade 5 to death. death.
Measured: At week 8
Severity of adverse clinical events
It is determined according to the Common Terminology Criteria for Adverse Events (CTCAE). The grade varies from 1 to 5. Grade 1 corresponds to mild severity and grade 5 to death.
Measured: At week 12
Severity of adverse clinical events
It is determined according to the Common Terminology Criteria for Adverse Events (CTCAE). The grade varies from 1 to 5. Grade 1 corresponds to mild severity and grade 5 to death.
Measured: At week 16
Severity of adverse clinical events
It is determined according to the Common Terminology Criteria for Adverse Events (CTCAE). The grade varies from 1 to 5. Grade 1 corresponds to mild severity and grade 5 to death.
Measured: At week 24
Severity of adverse clinical events
It is determined according to the Common Terminology Criteria for Adverse Events (CTCAE). The grade varies from 1 to 5. Grade 1 corresponds to mild severity and grade 5 to death.
Measured: At week 36
Severity of adverse clinical events
It is determined according to the Common Terminology Criteria for Adverse Events (CTCAE). The grade varies from 1 to 5. Grade 1 corresponds to mild severity and grade 5 to death.
Measured: At week 48
Changes in Tyndall score
The score is calculated according to the Standardization of Uveitis Nomenclature (SUN). It varies from grade 0 to grade 4+. The higher the grade the higher the number of cells in the anterior chamber.
Measured: At week 8
Changes in Tyndall score
The score is calculated according to the Standardization of Uveitis Nomenclature (SUN). It varies from grade 0 to grade 4+. The higher the grade the higher the number of cells in the anterio chamber.
Measured: At week 16
Changes in Tyndall score
The score is calculated according to the Standardization of Uveitis Nomenclature (SUN). It varies from grade 0 to grade 4+. The higher the grade the higher the number of cells in the anterior chamber.
Measured: At week 24
Changes in Tyndall score
The score is calculated according to the Standardization of Uveitis Nomenclature (SUN). It varies from grade 0 to grade 4+. The higher the grade the higher the number of cells in the anterior chamber.
Measured: At week 36
Changes in Tyndall score
The score is calculated according to the Standardization of Uveitis Nomenclature (SUN). It varies from grade 0 to grade 4+. The higher the grade the higher the number of cells in the anterior chamber.
Measured: At week 48
Changes in flare score
The score is calculated according to the Standardization of Uveitis Nomenclature (SUN). It varies from grade 0 to 4+. The higher the score, the higher the inflammation.
Measured: At week 8
Changes in flare score
The score is calculated according to the Standardization of Uveitis Nomenclature (SUN). It varies from grade 0 to 4+. The higher the score, the higher the inflammation.
Measured: At week 16
Changes in flare score
The score is calculated according to the Standardization of Uveitis Nomenclature (SUN). It varies from grade 0 to 4+. The higher the score, the higher the inflammation.
Measured: At week 24
Changes in flare score
The score is calculated according to the Standardization of Uveitis Nomenclature (SUN). It varies from grade 0 to 4+. The higher the score, the higher the inflammation.
Measured: At week 36
Changes in flare score
The score is calculated according to the Standardization of Uveitis Nomenclature (SUN). It varies from grade 0 to 4+. The higher the score, the higher the inflammation.
Measured: At week 48
Changes of Vitreous Haze
The score is calculated according to the Standardization of Uveitis Nomenclature (SUN). It varies between 0 and 4. The higher the score the higher the inflammation.
Measured: At week 8
Changes of Vitreous Haze
The score is calculated according to the Standardization of Uveitis Nomenclature (SUN). It varies between 0 and 4. The higher the score the higher the inflammation.
Measured: At week 16
Changes of Vitreous Haze
The score is calculated according to the Standardization of Uveitis Nomenclature (SUN). It varies between 0 and 4. The higher the score the higher the inflammation.
Measured: At week 24
Changes of Vitreous Haze
The score is calculated according to the Standardization of Uveitis Nomenclature (SUN). It varies between 0 and 4. The higher the score the higher the inflammation.
Measured: At week 36
Changes of Vitreous Haze
The score is calculated according to the Standardization of Uveitis Nomenclature (SUN). It varies between 0 and 4. The higher the score the higher the inflammation.
Measured: At week 48
Changes in Best corrected visual acuity
Evaluated by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score. The total score varies between 0 and 100. The higher score the better the visual acuity.
ETDRS Early Treatment Diabetic Retinopathy Study Research Group Treatment Diabetic Retinopathy Study design and baseline patient characteristics. ETDRS report number 7., Ophthalmology. 1991 May; 98(5 Suppl):741-756
Measured: At week 8
Changes in Best corrected visual acuity
Evaluated by ETDRS letters score. The total score varies between 0 and 100. The higher score the better the visual acuity
ETDRS Early Treatment Diabetic Retinopathy Study Research Group Treatment Diabetic Retinopathy Study design and baseline patient characteristics. ETDRS report number 7., Ophthalmology. 1991 May; 98(5 Suppl):741-756
Measured: At week 16
Changes in Best corrected visual acuity
Evaluated by ETDRS letters score. The total score varies between 0 and 100. The higher score the better the visual acuity
ETDRS Early Treatment Diabetic Retinopathy Study Research Group Treatment Diabetic Retinopathy Study design and baseline patient characteristics. ETDRS report number 7., Ophthalmology. 1991 May; 98(5 Suppl):741-756
Measured: At week 24
Changes in Best corrected visual acuity
Evaluated by ETDRS letters score. The total score varies between 0 and 100. The higher score the better the visual acuity
ETDRS Early Treatment Diabetic Retinopathy Study Research Group Treatment Diabetic Retinopathy Study design and baseline patient characteristics. ETDRS report number 7., Ophthalmology. 1991 May; 98(5 Suppl):741-756
Measured: At week 36
Changes in Best corrected visual acuity
Evaluated by ETDRS letters score. The total score varies between 0 and 100. The higher score the better the visual acuity
ETDRS Early Treatment Diabetic Retinopathy Study Research Group Treatment Diabetic Retinopathy Study design and baseline patient characteristics. ETDRS report number 7., Ophthalmology. 1991 May; 98(5 Suppl):741-756
Measured: At week 48
Changes in central retinal thickness
Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
Measured: At week 8
Changes in central retinal thickness
Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
Measured: At week 16
Changes in central retinal thickness
Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
Measured: At week 24
Changes in central retinal thickness
Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
Measured: At week 36
Changes in central retinal thickness
Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
Measured: At week 48
Percentage of patients with central retinal thickness <300 microns
Measured: At week 8
Percentage of patients with central retinal thickness <300 microns
Measured: At week 16
Percentage of patients with central retinal thickness <300 microns
Measured: At week 24
Percentage of patients with central retinal thickness <300 microns
Measured: At week 36
Percentage of patients with central retinal thickness <300 microns
Measured: At week 48
Percentage of patients without retinal vessel leakage on retinal angiography
in case of retinal vasculitis
Measured: At week 16
Percentage of patients without retinal vessel leakage on retinal angiography
in case of retinal vasculitis
Measured: At week 24
Percentage of patients without retinal vessel leakage on retinal angiography
in case of retinal vasculitis
Measured: At week 36
Percentage of patients without retinal vessel leakage on retinal angiography
in case of retinal vasculitis
Measured: At week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study startJul 2023 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behcet's UveitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874505
- Sponsor's protocol ID
- APHP200007
- Acronym
- UVB
- Status last verified
- Apr 2023
- First submitted
- 14 Apr 2023
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "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
- ClinicalTrials.gov ID
- NCT05874505
- Acronym / sponsor ID
- UVB / APHP200007
- Conditions
- Behcet's Uveitis
- Keywords
- Biologics, Adalimumab, Tocilizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adalimumab | Experimental | Drug: AdalimumabAdalimumab 80 mg at Day 0 then 40 mg subcutaneous at week 1, 3, 5, 7, 9, 11, 13 and 15 |
| Tocilizumab | Experimental | Drug: TocilizumabTocilizumab 162 mg subcutaneous each week for 15 weeks |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 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).
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdalimumabAdalimumab 80 mg at Day 0 then 40 mg subcutaneous at week 1, 3, 5, 7, 9, 11, 13 and 15 | Drug | Adalimumab |
| TocilizumabTocilizumab 162 mg subcutaneous each week for 15 weeks | Drug | Tocilizumab |
Primary outcome
Proportion of patients with complete remission of ocular involvement (Efficacy)
Time frame: At week 16 after randomization
Efficacy will be defined by a complete remission of ocular involvement with prednisone lower or equal to 5 mg/day . Ocular involvement response to treatment will be evaluated according to the Standardization of Uveitis Nomenclature (SUN) Workgroup criteria.
85 secondary outcomes
Percent of patients meeting the corticosteroid sparing targets
Time frame: At week 16 after randomization
Mean dose of corticosteroids
Time frame: At week 16 after randomization
Cumulative dose of corticosteroids
Time frame: At week 16 after randomization
Time to response onset
Time frame: Up to week 48
Erythrocyte sedimentation rate
Time frame: At week 4
Erythrocyte sedimentation rate
Time frame: At week 8
Erythrocyte sedimentation rate
Time frame: At week 12
Erythrocyte sedimentation rate
Time frame: At week 16
Erythrocyte sedimentation rate
Time frame: At week 24
Erythrocyte sedimentation rate
Time frame: At week 36
Erythrocyte sedimentation rate
Time frame: At week 48
C-reactive protein rate
Time frame: At week 4
C-reactive protein rate
Time frame: At week 8
C-reactive protein rate
Time frame: At week 12
C-reactive protein rate
Time frame: At week 16
C-reactive protein rate
Time frame: At week 24
C-reactive protein rate
Time frame: At week 36
C-reactive protein rate
Time frame: At week 48
Rate of relapses
Time frame: up to 48 weeks
Time to occurrence of relapse or worsening of uveitis
Time frame: up to 48 weeks
Disease activity assessed by Behcet's Disease Current Activity
Time frame: At week 8
Disease activity assessed by Behcet's Disease Current Activity
Time frame: At week 16
Disease activity assessed by Behcet's Disease Current Activity
Time frame: At week 24
Disease activity assessed by Behcet's Syndrome Activity Score
Time frame: At week 8
Disease activity assessed by Behcet's Syndrome Activity Score
Time frame: At week 16
Disease activity assessed by Behcet's Syndrome Activity Score
Time frame: week 24
Changes in the number of other organs involved by Behcet Disease (BD)
Time frame: At week 4
Changes in the number of other organs involved by Behcet Disease (BD)
Time frame: At week 8
Changes in the number of other organs involved by Behcet Disease (BD)
Time frame: At week 12
Changes in the number of other organs involved by Behcet Disease (BD)
Time frame: At week 16
Changes in the number of other organs involved by Behcet Disease (BD)
Time frame: At week 24
Changes in the number of other organs involved by Behcet Disease (BD)
Time frame: At week 36
Changes in the number of other organs involved by Behcet Disease (BD)
Time frame: At week 48
Quality of Life assessed by Behcet's Disease Quality of Life Measure
Time frame: At week 16
Quality of Life assessed by Behcet's Disease Quality of Life Measure
Time frame: At week 24
Changes in Short Form (36) Health Survey for quality of life
Time frame: At week 16
Changes in Short Form (36) Health Survey for quality of life
Time frame: At week 24
Proportion of patients with adverse clinical events
Time frame: at week 4
Proportion of patients with adverse clinical events
Time frame: at week 8
Proportion of patients with adverse clinical events
Time frame: at week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adalimumab and Tocilizumab in people with Behcet's Uveitis, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bahram BODAGHI, Pr (+33 1 42 16 37 28, bahram.bodaghi@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with complete remission of ocular involvement (Efficacy) (time frame: At week 16 after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.