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Long-term Safety of Gevokizumab in the Treatment of Patients With Chronic Non-infectious Uveitis (EYEGUARD-X) (EYEGUARD-X)
Servier Protocol Code:
CL3-78989-019
Sponsor:
Institut de Recherches Internationales Servier
Clinicaltrials.gov Identifier:
NCT02375685
EudraCT Number:
2013-004973-29
Find a recruiting site
How to participate in this study
If you think you are eligible for this study (see
below), you can identify the location closest to you and contact them directly. If you can’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
eligibility criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Name:
Institut de Recherches Internationales Servier, Département des études cliniques
Phone number:
+33 1 55 72 60 00
The study has 13 locations
Study description
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.
Official title: A Safety Open-label Study of Gevokizumab in the Treatment of Patients With Chronic Non-infectious Uveitis Disease, an eXtension Study. The EYEGUARD-X Study
Results
English (USA)Conditions
Chronic Uveitis
Interventions / Treatments
The treatment(s) given to the participants in the study.
- Gevokizumab
Other study id numbers
Other identification numbers the study may be known by.
- CL3-78989-019
Eligibility Criteria
Researchers look for people who fit a certain decription, called eligibility criteria. These include inclusion criteria and exclusion criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligible age for the study
18 years and older
(Adult, Older Adult)
Sex
Male/FemaleAccepts Healthy Volunteers
No- * either completed participation to one of the following: CL3-78989-002 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
- * Male or female, age ≥18 (or legal age of majority in the country) at selection.
- * For subject with reproductive potential, a willingness to use highly effective contraceptive measures
- * 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.
How is the study designed?
Allocation
How participants are assigned to different groups. Allocation can be random (randomized) or predetermined (non-randomized). Randomized means that participants are assigned at random to their participant group / arm.
Interventional study model
How treatments are given and tested in a study.
Single Group
A single group study design involves studying one group of participants who all receive the same treatment. Researchers observe the group's results to understand the effects of the treatment.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Intervention / Treatment
The treatment(s) given to the participants in the study.
Participant Group / Arm
A set of participants in the study who receive the same treatment or intervention.
Experimental:
gevokizumab
Intervention / Treatment
The treatment(s) given to the participants in the study.
Biological:
Gevokizumab
Keywords
Provided by Servier
Uveitis
Non-infectious Uveitis
Intermediate Uveitis
Posterior Uveitis
Behçet's disease uveitis
Additional Relevant MeSH Terms Glioma
Uveitis
Uveitis, Intermediate
Uveitis, Posterior