Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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11 January 2016 |
Main ID: |
EUCTR2013-004973-29-DE |
Date of registration:
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24/07/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Long-term safety of gevokizumab in the treatment of patients with chronic non-infectious uveitis, who previously well tolerated geovkizumab
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Scientific title:
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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. |
Date of first enrolment:
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13/08/2014 |
Target sample size:
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300 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004973-29 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 1
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Phase:
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Countries of recruitment
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Argentina
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Armenia
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Australia
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Austria
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Brazil
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Canada
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China
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European Union
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France
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Germany
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Greece
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Hong Kong
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Israel
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Italy
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Korea, Republic of
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Mexico
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Poland
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Portugal
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Russian Federation
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South Africa
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Spain
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Taiwan
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Tunisia
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Turkey
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United Kingdom
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Contacts
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Name:
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Clinical Studies Department
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Address:
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50 Rue Carnot
92284
Suresnes
France |
Telephone:
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+33155 72 43 66 |
Email:
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clinicaltrials@servier.com |
Affiliation:
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Institut de Recherches Internationales Servier |
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Name:
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Clinical Studies Department
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Address:
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50 Rue Carnot
92284
Suresnes
France |
Telephone:
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+33155 72 43 66 |
Email:
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clinicaltrials@servier.com |
Affiliation:
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Institut de Recherches Internationales Servier |
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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chronic non-infectious uveitis MedDRA version: 18.0
Level: LLT
Classification code 10022557
Term: Intermediate uveitis
System Organ Class: 10015919 - Eye disorders
MedDRA version: 18.0
Level: PT
Classification code 10069034
Term: Tubulointerstitial nephritis and uveitis syndrome
System Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 18.0
Level: LLT
Classification code 10036370
Term: Posterior uveitis
System Organ Class: 100000004862
MedDRA version: 18.0
Level: LLT
Classification code 10071139
Term: Behcet's uveitis
System Organ Class: 100000004866
MedDRA version: 18.0
Level: LLT
Classification code 10042745
Term: Sympathetic uveitis
System Organ Class: 10015919 - Eye disorders
MedDRA version: 18.0
Level: PT
Classification code 10012692
Term: Diabetic uveitis
System Organ Class: 10015919 - Eye disorders
MedDRA version: 18.0
Level: PT
Classification code 10046851
Term: Uveitis
System Organ Class: 10015919 - Eye disorders
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Therapeutic area: Diseases [C] - Eye Diseases [C11]
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Intervention(s)
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Product Name: Gevokizumab Product Code: S78989 Pharmaceutical Form: Solution for injection INN or Proposed INN: GEVOKIZUMAB CAS Number: 1129435-60-4 Current Sponsor code: S78989 Other descriptive name: GEVOKIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 60-
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Primary Outcome(s)
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Secondary Objective: Not applicable
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Timepoint(s) of evaluation of this end point: -Adverse events and vital signs : From inclusion until the end of the study -laboratory parameters and ophtalmologic assessment : each 16 weeks from inclusion until the end of the study
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Primary end point(s): Safety endpoints (adverse events assessment, vital signs, laboratory parameters, ophtalmological assessments,...)
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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
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Not applicable
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Secondary end point(s): Not Applicable
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Secondary ID(s)
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CL3-78989-019
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Source(s) of Monetary Support
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ADIR
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Laboratorios Servier, S.L
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Servier Research and Development Ltd
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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