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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
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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 document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
After Marketing Authorisation in EEA or US if the study is used for the approval.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://clinicaltrials.servier.com


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