EUCTR2009-014834-22-HUActive, not recruitingNot Applicable
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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 208
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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