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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Adalimumab 80 mg at Day 0 then 40 mg subcutaneous at week 1, 3, 5, 7, 9, 11, 13 and 15
Tocilizumab 162 mg subcutaneous each week for 15 weeks
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.
Time frame: At week 16 after randomization
Percent of patients meeting the corticosteroid sparing targets
lower than 0.1 mg/day/kg of prednisone
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
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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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. G. 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
Time frame: 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. G. 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
Time frame: 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.
Time frame: 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.
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
Proportion of patients with adverse clinical events
Time frame: at week 16
Proportion of patients with adverse clinical events
Time frame: at week 24
Proportion of patients with adverse clinical events
Time frame: at week 36
Proportion of patients with adverse clinical events
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At week 48
Changes in central retinal thickness
Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
Time frame: At week 8
Changes in central retinal thickness
Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
Time frame: At week 16
Changes in central retinal thickness
Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
Time frame: At week 24
Changes in central retinal thickness
Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
Time frame: At week 36
Changes in central retinal thickness
Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
Time frame: At week 48
Percentage of patients with central retinal thickness <300 microns
Time frame: At week 8
Percentage of patients with central retinal thickness <300 microns
Time frame: At week 16
Percentage of patients with central retinal thickness <300 microns
Time frame: At week 24
Percentage of patients with central retinal thickness <300 microns
Time frame: At week 36
Percentage of patients with central retinal thickness <300 microns
Time frame: At week 48
Percentage of patients without retinal vessel leakage on retinal angiography
in case of retinal vasculitis
Time frame: At week 16
Percentage of patients without retinal vessel leakage on retinal angiography
in case of retinal vasculitis
Time frame: At week 24
Percentage of patients without retinal vessel leakage on retinal angiography
in case of retinal vasculitis
Time frame: At week 36
Percentage of patients without retinal vessel leakage on retinal angiography
in case of retinal vasculitis
Time frame: At week 48
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