A 28-week multicenter, randomized, double-masked, placebo controlled, dose-ranging phase III study to assess AIN457 versus placebo in inducing and maintaining uveitis suppression in adults with active, non-infectious, intermediate, posterior or panuveitis requiring immunosuppression (INSURE Study) - INSURE

• Conditions: dose ranging phase III study to assess AIN457 versus placebo in inducing and maintaining uveitis suppression in adults with active, non-infectious, intermediate, posterior or panuveitis requiring immunosuppression; MedDRA version: 12.1Level: PTClassification code 10046851Term: Uveitis

• Registration Number: EUCTR2009-014834-22-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

Patients eligible for inclusion in this study have to fulfill all of the following criteria:
1.Male and female subjects =18 years of age. Where relevant, parents will also sign the informed consent according to local laws and regulations.
2.Patients with diagnosis of chronic non-infectious intermediate uveitis, posterior uveitis or panuveitis in at least one eye
3.Evidence of active intermediate, posterior or panuveitis (grade = 2+ vitreous haze with or without the presence of anterior chamber cells) at screening and baseline in at least one eye
4.Requirement for any of the following immunosuppressive therapies for the treatment or prevention of uveitis
•Prednisone or equivalent =10 mg daily at any time within the past 3 months
•=1 periocular injection or =1 intravitreal corticosteroid injection (e.g. triamcinolone) in the study eye within the past 6 months (the last injection must not have been given 6 weeks prior to screening)
•Treatment with either cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid, methotrexate at any time within the past 3 months. (Patients treated with chlorambucil or cyclophosphamide within the past 5 years are ineligible for the study)
•Patients not meeting the above specified criteria for immunosuppressive therapies are eligible for enrollment if they are intolerant to systemic immunosuppressive therapy as determined by the study investigator
5.Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
Ocular concomitant conditions/disease, specified in the protocol, page 26
Ocular treatments, specified in the protocol, page 26
Systemic conditions or treatments, specified in the protocol, page 26
Compliance/Administrative, specified in the protocol, page 27

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified