- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05874505
"Comparison of the Efficacy and Safety of Adalimumab to That of Tocilizumab in Severe Uveitis of Behçet's Disease" (UVB)
"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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Matthieu RESCHE-RIGON, Pr
- Phone Number: +33 1 42 49 97 42
- Email: matthieu.resche-rigon@u-paris.fr
Study Contact Backup
- Name: Bahram BODAGHI, Pr
- Phone Number: +33 1 42 16 37 28
- Email: bahram.bodaghi@aphp.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age >= 18 at Inclusion
- Provide written, informed consent prior to the performance of any study-specific procedures
- Diagnosis of Behçet's disease according to the International Criteria for Behçet's Disease (ICBD) or history of aphthosis.
- Diagnosis of non-infectious intermediate, posterior-, or pan-uveitis in at least one eye fulfilling the International Study Group Classification Criteria (Standardization of Uveitis Nomenclature [SUN] criteria) of posterior, or pan- uveitis
- Sight threatening uveitis defined according to the validated international definition as 2 lines of drop in visual acuity on a 10/10 scale, and/or retinal inflammation (macular oedema and/or retinal vasculitis).
- Chest X-ray (postero-anterior and lateral) or CT-scanner results within 12 weeks prior to Inclusion with no evidence of active Tuberculosis, active infection, or malignancy
- For female subjects of childbearing potential (premenopausal female capable of becoming pregnant) , a negative serum pregnancy test (plasmatic or urinary)
For subjects with reproductive potential, a willingness to use contraceptive measures adequate to prevent the subject or the subject's partner from becoming pregnant during the study and 3 and 5 months after stopping therapy for tocilizumab and adalimumab, respectively. Birth control methods which may be considered as highly effective methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods (according to CTFG recommendations). Such methods include:
combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
- oral
- intravaginal
- transdermal
progestogen-only hormonal contraception associated with inhibition of ovulation:
- oral
- injectable
- implantable
- intrauterine device (IUD)
- intrauterine hormone-releasing system (IUS)
- bilateral tubal occlusion
- vasectomised partner
- sexual abstinence (In the context of this guidance sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject).
For male subjects :
- use of a condom
- vasectomy (with documentation of azoospermia)
- sexual abstinence
- A potential subject with a positive interferon-gamma release assay (IGRA) (e.g., QuantiFERON®-TB Gold or T-spot TB® Test) obtained within 6 months prior to inclusion is eligible if her/his chest X-ray does not show evidence suggestive of active TB disease and there are no clinical signs and symptoms of pulmonary and/or extra-pulmonary TB disease. These subjects with a latent TB infection who have not already received a prophylactic TB treatment must agree in advance to complete such a treatment course. The treatment should be started at the latest at inclusion.
- Affiliation to a social security system. Patients affiliated to universal medical coverage (CMU) are eligible for the study
Exclusion Criteria:
- Infectious uveitis, masquerade syndromes, or uveitis due to causes other than BD uveitis
- Active tuberculosis or history of untreated tuberculosis and/or severe infection
- Positive HIV antibody and/or positive hepatitis B surface antigen and/or positive hepatitis C RNA, results obtained within 1 month prior to inclusion
- History of malignancy within 5 years prior to Inclusion other than carcinoma in situ of the cervix or adequately treated, non-metastatic squamous or basal cell carcinoma of the skin.
- History of severe allergic or anaphylactic reactions to monoclonal antibodies
- History of multiple sclerosis and/or demyelinating disorder
- Hypersensitivity to the active substance or an excipient of the Investigational Medicinal Product or the auxiliary medicine
- Active or suspected ocular infection
- Active or suspected systemic infection
- History of intestinal ulceration or diverticulitis
- Known porphyria
Laboratory values assessed during Inclusion:
- Neutrophil < 1.0 x 10^3 /mm3
- Platelet count < 80 x 10^3 /mm3
- ASAT or ALAT > 5 ULN
- Treatment with anti-TNF and/or Tocilizumab therapy within 1 month prior to inclusion
- if on azathioprine, mycophenolate mofetil, or methotrexate at the time of inclusion, these drugs must be withdrawn prior to receiving the tocilizumab or adalimumab dose on Day 0
- Stage III and IV New York Heart Association (NYHA) cardiac insufficiency
- Severe renal (Glomerular filtration rates (GFR) <30ml/min) or liver insufficiency (prothrombin <50% without other causes)
- Any live (attenuated) vaccine within 4 weeks prior to inclusion
- Breastfeeding or pregnant women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adalimumab
Adalimumab 80 mg at Day 0 then 40 mg subcutaneous at week 1, 3, 5, 7, 9, 11, 13 and 15
|
Adalimumab 80 mg at Day 0 then 40 mg subcutaneous at week 1, 3, 5, 7, 9, 11, 13 and 15
|
Experimental: Tocilizumab
Tocilizumab 162 mg subcutaneous each week for 15 weeks
|
Tocilizumab 162 mg subcutaneous each week for 15 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At week 16 after randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of patients meeting the corticosteroid sparing targets
Time Frame: At week 16 after randomization
|
lower than 0.1 mg/day/kg of prednisone
|
At week 16 after randomization
|
Mean dose of corticosteroids
Time Frame: At week 16 after randomization
|
At week 16 after randomization
|
|
Cumulative dose of corticosteroids
Time Frame: At week 16 after randomization
|
At week 16 after randomization
|
|
Time to response onset
Time Frame: Up to week 48
|
Up to week 48
|
|
Erythrocyte sedimentation rate
Time Frame: At week 4
|
At week 4
|
|
Erythrocyte sedimentation rate
Time Frame: At week 8
|
At week 8
|
|
Erythrocyte sedimentation rate
Time Frame: At week 12
|
At week 12
|
|
Erythrocyte sedimentation rate
Time Frame: At week 16
|
At week 16
|
|
Erythrocyte sedimentation rate
Time Frame: At week 24
|
At week 24
|
|
Erythrocyte sedimentation rate
Time Frame: At week 36
|
At week 36
|
|
Erythrocyte sedimentation rate
Time Frame: At week 48
|
At week 48
|
|
C-reactive protein rate
Time Frame: At week 4
|
At week 4
|
|
C-reactive protein rate
Time Frame: At week 8
|
At week 8
|
|
C-reactive protein rate
Time Frame: At week 12
|
At week 12
|
|
C-reactive protein rate
Time Frame: At week 16
|
At week 16
|
|
C-reactive protein rate
Time Frame: At week 24
|
At week 24
|
|
C-reactive protein rate
Time Frame: At week 36
|
At week 36
|
|
C-reactive protein rate
Time Frame: At week 48
|
At week 48
|
|
Rate of relapses
Time Frame: up to 48 weeks
|
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
|
up to 48 weeks
|
Time to occurrence of relapse or worsening of uveitis
Time Frame: up to 48 weeks
|
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
|
up to 48 weeks
|
Disease activity assessed by Behcet's Disease Current Activity
Time Frame: At week 8
|
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. |
At week 8
|
Disease activity assessed by Behcet's Disease Current Activity
Time Frame: At week 16
|
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. |
At week 16
|
Disease activity assessed by Behcet's Disease Current Activity
Time Frame: At week 24
|
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. |
At week 24
|
Disease activity assessed by Behcet's Syndrome Activity Score
Time Frame: At week 8
|
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. |
At week 8
|
Disease activity assessed by Behcet's Syndrome Activity Score
Time Frame: At week 16
|
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. |
At week 16
|
Disease activity assessed by Behcet's Syndrome Activity Score
Time Frame: week 24
|
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. |
week 24
|
Changes in the number of other organs involved by Behcet Disease (BD)
Time Frame: At week 4
|
At week 4
|
|
Changes in the number of other organs involved by Behcet Disease (BD)
Time Frame: At week 8
|
At week 8
|
|
Changes in the number of other organs involved by Behcet Disease (BD)
Time Frame: At week 12
|
At week 12
|
|
Changes in the number of other organs involved by Behcet Disease (BD)
Time Frame: At week 16
|
At week 16
|
|
Changes in the number of other organs involved by Behcet Disease (BD)
Time Frame: At week 24
|
At week 24
|
|
Changes in the number of other organs involved by Behcet Disease (BD)
Time Frame: At week 36
|
At week 36
|
|
Changes in the number of other organs involved by Behcet Disease (BD)
Time Frame: At week 48
|
At week 48
|
|
Quality of Life assessed by Behcet's Disease Quality of Life Measure
Time Frame: At week 16
|
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 |
At week 16
|
Quality of Life assessed by Behcet's Disease Quality of Life Measure
Time Frame: At week 24
|
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 |
At week 24
|
Changes in Short Form (36) Health Survey for quality of life
Time Frame: At week 16
|
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. |
At week 16
|
Changes in Short Form (36) Health Survey for quality of life
Time Frame: At week 24
|
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. |
At week 24
|
Proportion of patients with adverse clinical events
Time Frame: at week 4
|
at week 4
|
|
Proportion of patients with adverse clinical events
Time Frame: at week 8
|
at week 8
|
|
Proportion of patients with adverse clinical events
Time Frame: at week 12
|
at week 12
|
|
Proportion of patients with adverse clinical events
Time Frame: at week 16
|
at week 16
|
|
Proportion of patients with adverse clinical events
Time Frame: at week 24
|
at week 24
|
|
Proportion of patients with adverse clinical events
Time Frame: at week 36
|
at week 36
|
|
Proportion of patients with adverse clinical events
Time Frame: at week 48
|
at week 48
|
|
Severity of adverse clinical events
Time Frame: At week 4
|
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.
|
At week 4
|
Severity of adverse clinical events
Time Frame: At week 8
|
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.
|
At week 8
|
Severity of adverse clinical events
Time Frame: At week 12
|
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.
|
At week 12
|
Severity of adverse clinical events
Time Frame: At week 16
|
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.
|
At week 16
|
Severity of adverse clinical events
Time Frame: At week 24
|
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.
|
At week 24
|
Severity of adverse clinical events
Time Frame: At week 36
|
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.
|
At week 36
|
Severity of adverse clinical events
Time Frame: At week 48
|
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.
|
At week 48
|
Changes in Tyndall score
Time Frame: At week 8
|
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.
|
At week 8
|
Changes in Tyndall score
Time Frame: At week 16
|
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.
|
At week 16
|
Changes in Tyndall score
Time Frame: At week 24
|
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.
|
At week 24
|
Changes in Tyndall score
Time Frame: At week 36
|
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.
|
At week 36
|
Changes in Tyndall score
Time Frame: At week 48
|
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.
|
At week 48
|
Changes in flare score
Time Frame: At week 8
|
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.
|
At week 8
|
Changes in flare score
Time Frame: At week 16
|
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.
|
At week 16
|
Changes in flare score
Time Frame: At week 24
|
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.
|
At week 24
|
Changes in flare score
Time Frame: At week 36
|
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.
|
At week 36
|
Changes in flare score
Time Frame: At week 48
|
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.
|
At week 48
|
Changes of Vitreous Haze
Time Frame: At week 8
|
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.
|
At week 8
|
Changes of Vitreous Haze
Time Frame: At week 16
|
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.
|
At week 16
|
Changes of Vitreous Haze
Time Frame: At week 24
|
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.
|
At week 24
|
Changes of Vitreous Haze
Time Frame: At week 36
|
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.
|
At week 36
|
Changes of Vitreous Haze
Time Frame: At week 48
|
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.
|
At week 48
|
Changes in Best corrected visual acuity
Time Frame: At week 8
|
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 |
At week 8
|
Changes in Best corrected visual acuity
Time Frame: At week 16
|
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 |
At week 16
|
Changes in Best corrected visual acuity
Time Frame: At week 24
|
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 |
At week 24
|
Changes in Best corrected visual acuity
Time Frame: At week 36
|
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 |
At week 36
|
Changes in Best corrected visual acuity
Time Frame: At week 48
|
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 |
At week 48
|
Changes in central retinal thickness
Time Frame: At week 8
|
Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
|
At week 8
|
Changes in central retinal thickness
Time Frame: At week 16
|
Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
|
At week 16
|
Changes in central retinal thickness
Time Frame: At week 24
|
Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
|
At week 24
|
Changes in central retinal thickness
Time Frame: At week 36
|
Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
|
At week 36
|
Changes in central retinal thickness
Time Frame: At week 48
|
Changes in central retinal thickness measured with Optical Coherence Tomography (OCT)
|
At week 48
|
Percentage of patients with central retinal thickness <300 microns
Time Frame: At week 8
|
At week 8
|
|
Percentage of patients with central retinal thickness <300 microns
Time Frame: At week 16
|
At week 16
|
|
Percentage of patients with central retinal thickness <300 microns
Time Frame: At week 24
|
At week 24
|
|
Percentage of patients with central retinal thickness <300 microns
Time Frame: At week 36
|
At week 36
|
|
Percentage of patients with central retinal thickness <300 microns
Time Frame: At week 48
|
At week 48
|
|
Percentage of patients without retinal vessel leakage on retinal angiography
Time Frame: At week 16
|
in case of retinal vasculitis
|
At week 16
|
Percentage of patients without retinal vessel leakage on retinal angiography
Time Frame: At week 24
|
in case of retinal vasculitis
|
At week 24
|
Percentage of patients without retinal vessel leakage on retinal angiography
Time Frame: At week 36
|
in case of retinal vasculitis
|
At week 36
|
Percentage of patients without retinal vessel leakage on retinal angiography
Time Frame: At week 48
|
in case of retinal vasculitis
|
At week 48
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Eye Diseases
- Genetic Diseases, Inborn
- Stomatognathic Diseases
- Mouth Diseases
- Uveitis, Anterior
- Panuveitis
- Uveal Diseases
- Vasculitis
- Hereditary Autoinflammatory Diseases
- Skin Diseases, Genetic
- Skin Diseases, Vascular
- Behcet Syndrome
- Uveitis
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Tumor Necrosis Factor Inhibitors
- Adalimumab
Other Study ID Numbers
- APHP200007
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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