A study of gevokizumab in subjects with Behçet?s disease uveitis
Not Applicable
Completed
- Conditions
- Behçet?s disease uveitisSkin and Connective Tissue DiseasesBehçet's disease
- Registration Number
- ISRCTN15180871
- Lead Sponsor
- Institut de Recherches Internationales Servier (France)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
1. Patients with uveitis associated with Behçet's disease diagnosis fulfilling the International Study Group Classification Criteria
2. Male or female, age [18 or legal age of majority- 80] years old
3. Stable regimen of oral corticosteroids and at least one immunosuppressive treatment
Exclusion Criteria
1. Infectious uveitis, uveitis due to causes other than Behçet's disease, or uveitis of unknown origin
2. Cataract so severe that an assessment of the posterior segment of the uvea and the fundus is inadequate or impossible
3. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety evaluation throughout the study<br>1. Adverse events<br>2. Vital signs<br>3. Laboratory values<br>4. Standard 12-lead electrocardiograms (ECGs) and chest X-ray at baseline and at study end
- Secondary Outcome Measures
Name Time Method 1. Pharmacokinetics from baseline until the study end (serum samples)<br>2. Ophthalmological assessments