Clinical Trial: Safety and Efficacy of AIN457 in Noninfectious Uveitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open-label Proof-of-concept Study With a Double-masked, Dose-ranging Component to Assess the Effects of AIN457 in Patients With Noninfectious Uveitis
Brief Summary: This study will test the efficacy and safety of AIN457 for patients with active uveitis that requires systemic immunosuppression.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Safety assessments will include ocular examinations, physical examination, and adverse events [ Time Frame: Baseline day through nine months ]
Original Primary Outcome: To assess the safety and tolerability of intravenous AIN457A in the treatment of non-infectious uveitis
Current Secondary Outcome:
- Reduction in ocular inflammation [ Time Frame: One week through nine months ]
- Reduction in other immunosuppressant drugs [ Time Frame: One week through nine months ]
- Ability to induce a remission in uveitis [ Time Frame: one week through nine months ]
- Duration of remission in uveitis [ Time Frame: one week through nine months ]
- Ability to re-induce a remission if a flare-up occurs [ Time Frame: One week through nine months ]
Original Secondary Outcome:
- To investigate how many uveitis patients will have a reduction in uveitis in response to AIN457
- To investigate how many patients will be able to reduce their use of corticosteroids
- To assess the pharmacokinetics of intravenous AIN457 in patients with uveitis
Information By: Novartis
Dates:
Date Received: May 23, 2008
Date Started: June 2008
Date Completion:
Last Updated: November 18, 2013
Last Verified: November 2013
