Condition category
Skin and Connective Tissue Diseases
Date applied
20/02/2012
Date assigned
04/04/2012
Last edited
01/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ahmet Gul

ORCID ID

Contact details

Istanbul University
Istanbul Faculty of Medicine
Department of Internal Medicine
Division of Rheumatology
Istanbul
34390
Turkey

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CL2-78989-001 / X052096

Study information

Scientific title

An open-label safety and pharmacokinetic study of gevokizumab in subjects with Behçet’s disease uveitis

Acronym

Study hypothesis

To evaluate the safety of gevokizumab as well the drug concentration in the blood of patients with Behçet’s Disease Uveitis

Ethics approval

Ethics approval was obtained before recruitment of the first participants

Study design

International multicentre randomized open-label parallel group descriptive study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Behçet’s disease uveitis

Intervention

Three open treatment arms on top of stable background treatment for a one year period, with either :
Gevokizumab
1. Dose 1 intravenous (IV) followed by monthly dose 1 subcutaneous (SC), or
2. Dose 1 IV followed by dose 2 SC, or
3. Dose 2 IV followed by monthly dose 2 IV
In addition for patients with an acute ocular exacerbation at presentation, an IV injection is repeated 2 to 3 weeks later, before continuing monthly administrations

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Safety evaluation throughout the study
1. Adverse events
2. Vital signs
3. Laboratory values
4. Standard 12-lead electrocardiograms (ECGs) and chest X-ray at baseline and at study end

Secondary outcome measures

1. Pharmacokinetics from baseline until the study end (serum samples)
2. Ophthalmological assessments

Overall trial start date

01/02/2012

Overall trial end date

01/05/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with uveitis associated with Behçet's disease diagnosis fulfilling the International Study Group Classification Criteria
2. Male or female, age [18 or legal age of majority- 80] years old
3. Stable regimen of oral corticosteroids and at least one immunosuppressive treatment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

21

Participant exclusion criteria

1. Infectious uveitis, uveitis due to causes other than Behçet's disease, or uveitis of unknown origin
2. Cataract so severe that an assessment of the posterior segment of the uvea and the fundus is inadequate or impossible
3. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies

Recruitment start date

01/02/2012

Recruitment end date

01/05/2013

Locations

Countries of recruitment

Korea, South, Tunisia, Turkey

Trial participating centre

Istanbul University
Istanbul
34390
Turkey

Sponsor information

Organisation

Institut de Recherches Internationales Servier (France)

Sponsor details

50 rue Carnot
Suresnes
92284
France

Sponsor type

Industry

Website

http://www.servier.com/

Funders

Funder type

Industry

Funder name

Institut de Recherches Internationales Servier (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes