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Long-term Safety of Gevokizumab in the Treatment of Patients With Chronic Non-infectious Uveitis (EYEGUARD-X) (EYEGUARD-X)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02375685
Recruitment Status : Terminated
First Posted : March 3, 2015
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Servier ( Institut de Recherches Internationales Servier )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Uveitis Biological: Gevokizumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: gevokizumab Biological: Gevokizumab


Outcome Measures
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Primary Outcome Measures :
  1. Safety endpoints (adverse events, ...) [ Time Frame: 108 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375685


Locations
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Australia
Lions Eye Institute
Nedlands, Australia, 6009
Austria
Medical Competence
Wien, Austria, 1030
France
CHU-Hôtel Dieu
Nantes, France, 44000
Germany
Universitätsklinikum
Tübingen, Germany, 72076
Greece
Interbalkan Medical Center
Thessaloníki, Greece, 57 001
Italy
Ospedale San Raffaele
Milano, Italy, 20132
Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of, 03722
Portugal
AIBILI
Coimbra, Portugal, 3000-548
Spain
ICOF ( Institut Clinic d'Oftalmologia )
Barcelona, Spain, 08028
Taiwan
Chang Gung Memorial Hospital-Linkou
Taoyuan, Taiwan
Tunisia
Fattouma Bourguiba University hospital
Monastir, Tunisia, 5000
Turkey
Istanbul University
Istanbul, Turkey, 34390
United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, United Kingdom, EC1V 2PD
Sponsors and Collaborators
Institut de Recherches Internationales Servier
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Institut de Recherches Internationales Servier
ClinicalTrials.gov Identifier: NCT02375685    
Other Study ID Numbers: CL3-78989-019
2013-004973-29 ( EudraCT Number )
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs).

They can ask all interventional clinical studies:

  • submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
  • Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After Marketing Authorisation in EEA or US if the study is used for the approval.
Access Criteria: Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
URL: http://clinicaltrials.servier.com
Keywords provided by Servier ( Institut de Recherches Internationales Servier ):
Uveitis
Non-infectious Uveitis
Intermediate Uveitis
Posterior Uveitis
Behçet's disease uveitis
Additional relevant MeSH terms:
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Uveitis
Uveal Diseases
Eye Diseases