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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02375685




Registration number
NCT02375685
Ethics application status
Date submitted
16/02/2015
Date registered
3/03/2015

Titles & IDs
Public title
Long-term Safety of Gevokizumab in the Treatment of Patients With Chronic Non-infectious Uveitis (EYEGUARD-X)
Scientific 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
Secondary ID [1] 0 0
2013-004973-29
Secondary ID [2] 0 0
CL3-78989-019
Universal Trial Number (UTN)
Trial acronym
EYEGUARD-X
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Uveitis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: gevokizumab -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety endpoints (adverse events, ...)
Timepoint [1] 0 0
108 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2015
Sample size
Target
Accrual to date
Final
71
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Lions Eye Institute - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Wien
Country [2] 0 0
France
State/province [2] 0 0
Nantes
Country [3] 0 0
Germany
State/province [3] 0 0
Tübingen
Country [4] 0 0
Greece
State/province [4] 0 0
Thessaloníki
Country [5] 0 0
Italy
State/province [5] 0 0
Milano
Country [6] 0 0
Korea, Republic of
State/province [6] 0 0
Seoul
Country [7] 0 0
Portugal
State/province [7] 0 0
Coimbra
Country [8] 0 0
Spain
State/province [8] 0 0
Barcelona
Country [9] 0 0
Taiwan
State/province [9] 0 0
Taoyuan
Country [10] 0 0
Tunisia
State/province [10] 0 0
Monastir
Country [11] 0 0
Turkey
State/province [11] 0 0
Istanbul
Country [12] 0 0
United Kingdom
State/province [12] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Institut de Recherches Internationales Servier
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Tugal-Tutkun I, Pavesio C, De Cordoue A, Bernard-P... [More Details]


Results not provided in https://clinicaltrials.gov/study/NCT02375685