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"Comparison of the Efficacy and Safety of Adalimumab to That of Tocilizumab in Severe Uveitis of Behçet's Disease" (UVB)

Primary Purpose

Behcet's Uveitis

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Adalimumab
Tocilizumab
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Behcet's Uveitis focused on measuring Biologics, Adalimumab, Tocilizumab

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Adalimumab

    Tocilizumab

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Percent of patients meeting the corticosteroid sparing targets
    lower than 0.1 mg/day/kg of prednisone
    Mean dose of corticosteroids
    Cumulative dose of corticosteroids
    Time to response onset
    Erythrocyte sedimentation rate
    Erythrocyte sedimentation rate
    Erythrocyte sedimentation rate
    Erythrocyte sedimentation rate
    Erythrocyte sedimentation rate
    Erythrocyte sedimentation rate
    Erythrocyte sedimentation rate
    C-reactive protein rate
    C-reactive protein rate
    C-reactive protein rate
    C-reactive protein rate
    C-reactive protein rate
    C-reactive protein rate
    C-reactive protein rate
    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 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
    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.
    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.
    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.
    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.
    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.
    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.
    Changes in the number of other organs involved by Behcet Disease (BD)
    Changes in the number of other organs involved by Behcet Disease (BD)
    Changes in the number of other organs involved by Behcet Disease (BD)
    Changes in the number of other organs involved by Behcet Disease (BD)
    Changes in the number of other organs involved by Behcet Disease (BD)
    Changes in the number of other organs involved by Behcet Disease (BD)
    Changes in the number of other organs involved by Behcet Disease (BD)
    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
    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
    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.
    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.
    Proportion of patients with adverse clinical events
    Proportion of patients with adverse clinical events
    Proportion of patients with adverse clinical events
    Proportion of patients with adverse clinical events
    Proportion of patients with adverse clinical events
    Proportion of patients with adverse clinical events
    Proportion of patients with adverse clinical events
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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
    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
    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
    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
    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
    Changes in central retinal thickness
    Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
    Changes in central retinal thickness
    Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
    Changes in central retinal thickness
    Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
    Changes in central retinal thickness
    Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
    Changes in central retinal thickness
    Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
    Percentage of patients with central retinal thickness <300 microns
    Percentage of patients with central retinal thickness <300 microns
    Percentage of patients with central retinal thickness <300 microns
    Percentage of patients with central retinal thickness <300 microns
    Percentage of patients with central retinal thickness <300 microns
    Percentage of patients without retinal vessel leakage on retinal angiography
    in case of retinal vasculitis
    Percentage of patients without retinal vessel leakage on retinal angiography
    in case of retinal vasculitis
    Percentage of patients without retinal vessel leakage on retinal angiography
    in case of retinal vasculitis
    Percentage of patients without retinal vessel leakage on retinal angiography
    in case of retinal vasculitis

    Full Information

    First Posted
    April 14, 2023
    Last Updated
    May 15, 2023
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05874505
    Brief Title
    "Comparison of the Efficacy and Safety of Adalimumab to That of Tocilizumab in Severe Uveitis of Behçet's Disease"
    Acronym
    UVB
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    November 2026 (Anticipated)
    Study Completion Date
    July 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Assistance Publique - Hôpitaux de Paris

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Behcet's Uveitis
    Keywords
    Biologics, Adalimumab, Tocilizumab

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Adalimumab
    Arm Type
    Experimental
    Arm Description
    Adalimumab 80 mg at Day 0 then 40 mg subcutaneous at week 1, 3, 5, 7, 9, 11, 13 and 15
    Arm Title
    Tocilizumab
    Arm Type
    Experimental
    Arm Description
    Tocilizumab 162 mg subcutaneous each week for 15 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Adalimumab
    Intervention Description
    Adalimumab 80 mg at Day 0 then 40 mg subcutaneous at week 1, 3, 5, 7, 9, 11, 13 and 15
    Intervention Type
    Drug
    Intervention Name(s)
    Tocilizumab
    Intervention Description
    Tocilizumab 162 mg subcutaneous each week for 15 weeks
    Primary Outcome Measure Information:
    Title
    Proportion of patients with complete remission of ocular involvement (Efficacy)
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Percent of patients meeting the corticosteroid sparing targets
    Description
    lower than 0.1 mg/day/kg of prednisone
    Time Frame
    At week 16 after randomization
    Title
    Mean dose of corticosteroids
    Time Frame
    At week 16 after randomization
    Title
    Cumulative dose of corticosteroids
    Time Frame
    At week 16 after randomization
    Title
    Time to response onset
    Time Frame
    Up to week 48
    Title
    Erythrocyte sedimentation rate
    Time Frame
    At week 4
    Title
    Erythrocyte sedimentation rate
    Time Frame
    At week 8
    Title
    Erythrocyte sedimentation rate
    Time Frame
    At week 12
    Title
    Erythrocyte sedimentation rate
    Time Frame
    At week 16
    Title
    Erythrocyte sedimentation rate
    Time Frame
    At week 24
    Title
    Erythrocyte sedimentation rate
    Time Frame
    At week 36
    Title
    Erythrocyte sedimentation rate
    Time Frame
    At week 48
    Title
    C-reactive protein rate
    Time Frame
    At week 4
    Title
    C-reactive protein rate
    Time Frame
    At week 8
    Title
    C-reactive protein rate
    Time Frame
    At week 12
    Title
    C-reactive protein rate
    Time Frame
    At week 16
    Title
    C-reactive protein rate
    Time Frame
    At week 24
    Title
    C-reactive protein rate
    Time Frame
    At week 36
    Title
    C-reactive protein rate
    Time Frame
    At week 48
    Title
    Rate of relapses
    Description
    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
    Title
    Time to occurrence of relapse or worsening of uveitis
    Description
    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
    Title
    Disease activity assessed by Behcet's Disease Current Activity
    Description
    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
    Title
    Disease activity assessed by Behcet's Disease Current Activity
    Description
    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
    Title
    Disease activity assessed by Behcet's Disease Current Activity
    Description
    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
    Title
    Disease activity assessed by Behcet's Syndrome Activity Score
    Description
    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
    Title
    Disease activity assessed by Behcet's Syndrome Activity Score
    Description
    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
    Title
    Disease activity assessed by Behcet's Syndrome Activity Score
    Description
    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
    Title
    Changes in the number of other organs involved by Behcet Disease (BD)
    Time Frame
    At week 4
    Title
    Changes in the number of other organs involved by Behcet Disease (BD)
    Time Frame
    At week 8
    Title
    Changes in the number of other organs involved by Behcet Disease (BD)
    Time Frame
    At week 12
    Title
    Changes in the number of other organs involved by Behcet Disease (BD)
    Time Frame
    At week 16
    Title
    Changes in the number of other organs involved by Behcet Disease (BD)
    Time Frame
    At week 24
    Title
    Changes in the number of other organs involved by Behcet Disease (BD)
    Time Frame
    At week 36
    Title
    Changes in the number of other organs involved by Behcet Disease (BD)
    Time Frame
    At week 48
    Title
    Quality of Life assessed by Behcet's Disease Quality of Life Measure
    Description
    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
    Title
    Quality of Life assessed by Behcet's Disease Quality of Life Measure
    Description
    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
    Title
    Changes in Short Form (36) Health Survey for quality of life
    Description
    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
    Title
    Changes in Short Form (36) Health Survey for quality of life
    Description
    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
    Title
    Proportion of patients with adverse clinical events
    Time Frame
    at week 4
    Title
    Proportion of patients with adverse clinical events
    Time Frame
    at week 8
    Title
    Proportion of patients with adverse clinical events
    Time Frame
    at week 12
    Title
    Proportion of patients with adverse clinical events
    Time Frame
    at week 16
    Title
    Proportion of patients with adverse clinical events
    Time Frame
    at week 24
    Title
    Proportion of patients with adverse clinical events
    Time Frame
    at week 36
    Title
    Proportion of patients with adverse clinical events
    Time Frame
    at week 48
    Title
    Severity of adverse clinical events
    Description
    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
    Title
    Severity of adverse clinical events
    Description
    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
    Title
    Severity of adverse clinical events
    Description
    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
    Title
    Severity of adverse clinical events
    Description
    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
    Title
    Severity of adverse clinical events
    Description
    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
    Title
    Severity of adverse clinical events
    Description
    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
    Title
    Severity of adverse clinical events
    Description
    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
    Title
    Changes in Tyndall score
    Description
    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
    Title
    Changes in Tyndall score
    Description
    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
    Title
    Changes in Tyndall score
    Description
    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
    Title
    Changes in Tyndall score
    Description
    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
    Title
    Changes in Tyndall score
    Description
    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
    Title
    Changes in flare score
    Description
    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
    Title
    Changes in flare score
    Description
    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
    Title
    Changes in flare score
    Description
    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
    Title
    Changes in flare score
    Description
    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
    Title
    Changes in flare score
    Description
    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
    Title
    Changes of Vitreous Haze
    Description
    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
    Title
    Changes of Vitreous Haze
    Description
    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
    Title
    Changes of Vitreous Haze
    Description
    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
    Title
    Changes of Vitreous Haze
    Description
    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
    Title
    Changes of Vitreous Haze
    Description
    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
    Title
    Changes in Best corrected visual acuity
    Description
    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
    Title
    Changes in Best corrected visual acuity
    Description
    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
    Title
    Changes in Best corrected visual acuity
    Description
    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
    Title
    Changes in Best corrected visual acuity
    Description
    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
    Title
    Changes in Best corrected visual acuity
    Description
    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
    Title
    Changes in central retinal thickness
    Description
    Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
    Time Frame
    At week 8
    Title
    Changes in central retinal thickness
    Description
    Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
    Time Frame
    At week 16
    Title
    Changes in central retinal thickness
    Description
    Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
    Time Frame
    At week 24
    Title
    Changes in central retinal thickness
    Description
    Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
    Time Frame
    At week 36
    Title
    Changes in central retinal thickness
    Description
    Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
    Time Frame
    At week 48
    Title
    Percentage of patients with central retinal thickness <300 microns
    Time Frame
    At week 8
    Title
    Percentage of patients with central retinal thickness <300 microns
    Time Frame
    At week 16
    Title
    Percentage of patients with central retinal thickness <300 microns
    Time Frame
    At week 24
    Title
    Percentage of patients with central retinal thickness <300 microns
    Time Frame
    At week 36
    Title
    Percentage of patients with central retinal thickness <300 microns
    Time Frame
    At week 48
    Title
    Percentage of patients without retinal vessel leakage on retinal angiography
    Description
    in case of retinal vasculitis
    Time Frame
    At week 16
    Title
    Percentage of patients without retinal vessel leakage on retinal angiography
    Description
    in case of retinal vasculitis
    Time Frame
    At week 24
    Title
    Percentage of patients without retinal vessel leakage on retinal angiography
    Description
    in case of retinal vasculitis
    Time Frame
    At week 36
    Title
    Percentage of patients without retinal vessel leakage on retinal angiography
    Description
    in case of retinal vasculitis
    Time Frame
    At week 48

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bahram BODAGHI, Pr
    Phone
    +33 1 42 16 37 28
    Email
    bahram.bodaghi@aphp.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Matthieu RESCHE-RIGON, Pr
    Phone
    +33 1 42 49 97 42
    Email
    matthieu.resche-rigon@u-paris.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    "Comparison of the Efficacy and Safety of Adalimumab to That of Tocilizumab in Severe Uveitis of Behçet's Disease"

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