JAPIC ID: JapicCTI-101084
Registered date:
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | non-infectiouse uveitis |
Date of first enrollment | 26/4/2010 |
Target sample size | 208 |
Countries of recruitment | |
Study type | INTERVENTIONAL |
Intervention(s) | Intervention name : AIN457 Dosage And administration of the intervention : subcutaneous injection Control intervention name : null |
Outcome(s)
Primary Outcome | mean change in vitreous haze grade in the study eye from baseline to 28 weeks |
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Secondary Outcome | change in immunosuppressive medication score from baseline to Week 28 |
Key inclusion & exclusion criteria
Age minimum | 18 |
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Age maximum | |
Gender | BOTH |
Include criteria | - Male and female subjects 18 years of age or older - Patients with diagnosis of chronic non-infectious intermediate uveitis, posterior uveitis or panuveitis in at least one eye - Evidence of active intermediate, posterior or panuveitis at screening and baseline in at least one eye - Requirement for any of the immunosuppressive therapies for the treatment or prevention of uveitis |
Exclude criteria | - Patients with a primary diagnosis of Behcet's disease or anterior uveitis - Any intermediate uveitis, posterior uveitis or panuveitis in which the manifestation(s) of the active intraocular inflammatory disease may spontaneously resolve or that are not characterized by the presence of either anterior chamber cells or vitritis such as the white dot retino-choroidopathies - Patients with infectious uveitis |
Related Information
Primary Sponsor | Novartis Pharma K.K. |
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Secondary Sponsor | |
Source(s) of Monetary Support | Refer to the information of contact(s) |
Contact
public contact | |
Name | Novartis Pharma K.K. Novartis Direct |
Address | 0120-003-293 |
Telephone | |
Affiliation | |
scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |