Efficacy of gevokizumab in the treatment of patients with Behçet's disease uveitis

• Conditions: Behçet’s disease uveitis; MedDRA version: 15.0Level: LLTClassification code 10071139Term: Behcet's uveitisSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-001125-27-GR
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-13
• Last Update Posted: 26 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

- Behçet’s disease diagnosis fulfilling the International Study Group Classification Criteria.
- History of Behçet’s disease uveitis with ocular involvement of the posterior segment.
- Patients with a stable backgroud treatment of oral corticosteroid and at least one immunosuppressive drug.
- Male or female, age =18 (or legal age of majority in the country) at selection
- For subjects with reproductive potential, a willingness to use highly effective contraceptive measures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 95
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

- Infectious uveitis, uveitis due to causes other than Behçet’s disease.
- Monocular vision
- Presence of severe cataract or severe posterior capsular opacification.
- Contraindication to mydriasis or presence of posterior synechiae.
- Active TB disease.
- History of severe allergic or anaphylactic reactions to monoclonal antibodies
- History of malignancy within 5 years prior to Selection.
- Infectious disease.
- Known immunodeficiency.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified