ong-term safety of gevokizumab in the treatment of patients with chronic non-infectious uveitis, who previously well tolerated geovkizumab

• Conditions: chronic non-infectious uveitis; MedDRA version: 18.0Level: LLTClassification code 10022557Term: Intermediate uveitisSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 18.0Level: PTClassification code 10069034Term: Tubulointerstitial nephritis and uveitis syndromeSystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 18.0Level: LLTClassification code 10036370Term: Posterior uveitisSystem Organ Class: 100000004862; MedDRA version: 18.0Level: LLTClassification code 10071139Term: Behcet's uveitisSystem Organ Class: 100000004866; MedDRA version: 18.0Level: LLTClassification code 10042745Term: Sympathetic uveitisSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 18.0Level: PTClassification code 10012692Term: Diabetic uveitisSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 18.0Level: PTClassification code 10046851Term: UveitisSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2013-004973-29-DE
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-24
• Last Update Posted: 11 January 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

- either completed participation to one of the following : CL3-78989-002 double masked period or open label extension, or X052130/CL3-78989-005 double masked period or open label period, or X052131/CL3-78989-006 double masked period or open label period, or currently benefiting from gevokizumab compassionate use after participation in gevokizumab uveitis studies,
- Able to receive the first injection of gevokizumab within 6 weeks after the last study drug administration. In some exceptional cases when the time period since last study drug administration in previous studies is more than 6 weeks, patients should be considered in the investigator's opinion in stable ophtalmological conditions at the inclusion visit.
- 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 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Meeting criteria for discontinuation of any of gevokizumab uveitis previous study.
- Infectious uveitis and masquerade syndrome.
- History of severe allergic or anaphylactic reaction to study drug administration during previous study or to gevokizumab or any of its excipient.
- Currently active Infectious disease.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to evaluate long-term safety of gevokizumab in patient with chronic non-infectious uveitis who previously well tolerated the study drug and may benefit from longterm treatment with gevokizumab;Secondary Objective: Not applicable;Primary end point(s): Safety endpoints (adverse events assessment, vital signs, laboratory parameters, ophtalmological assessments,...);Timepoint(s) of evaluation of this end point: -Adverse events and vital signs : From inclusion until the end of the study<br>-laboratory parameters and ophtalmologic assessment : each 16 weeks from inclusion until the end of the study

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Not applicable;Secondary end point(s): Not Applicable