Active Uveitis That is Not From an Infection. Clinical Trial
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
This study will test the efficacy and safety of AIN457 for patients with active uveitis that requires systemic immunosuppression.
| Status | Completed |
| Enrollment | 79 |
| Est. completion date | September 2013 |
| Est. primary completion date | September 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion criteria: - Active uveitis (i.e., uveitis that is not in remission). - Intermediate uveitis, posterior uveitis, or panuveitis must be sufficiently severe that systemic immunosuppression is indicated. Exclusion criteria: - Active infection. - Weight must not be greater that 120kg. Other protocol-defined inclusion/exclusion criteria may apply |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Novartis Investigative Site | Berlin | |
| Germany | Novartis Investigative Site | Freiburg | |
| Germany | Novartis Investigative Site | Heidelberg | |
| Germany | Novartis Investigative Site | Tübingen | |
| United States | Novartis Investigative Site | Arlington | Texas |
| United States | Novartis Investigative Site | Atlanta | Georgia |
| United States | Novartis Investigative Site | Austin | Texas |
| United States | Novartis Investigative Site | Baltimore | Maryland |
| United States | Novartis Investigative Site | Baltimore | Maryland |
| United States | Novartis Investigative Site | Beverly Hills | California |
| United States | Novartis Investigative Site | Cambridge | Massachusetts |
| United States | Novartis Investigative Site | Cleveland | Ohio |
| United States | Novartis Investigative Site | Denver | Colorado |
| United States | Novartis Investigative Site | Durham | North Carolina |
| United States | Novartis Investigative Site | Golden | Colorado |
| United States | Novartis Investigative Site | Houston | Texas |
| United States | Novartis Investigative Site | Houston | Texas |
| United States | Novartis Investigative Site | Kansas City | Missouri |
| United States | Novartis Investigative Site | Leawood | Kansas |
| United States | Novartis Investigative Site | Littleton | Colorado |
| United States | Novartis Investigative Site | Lone Tree | Colorado |
| United States | Novartis Investigative Site | Los Angeles | California |
| United States | Novartis Investigative Site | New York | New York |
| United States | Novartis Investigative Site | Portland | Oregon |
| United States | Novartis Investigative Site | Sacramento | California |
| United States | Novartis Investigative Site | Slingerlands | New York |
| United States | Novartis Investigative Site | Spartanburg | South Carolina |
| United States | Novartis Investigative Site | Teaneck | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety assessments will include ocular examinations, physical examination, and adverse events | Baseline day through nine months | Yes | |
| Secondary | Reduction in ocular inflammation | One week through nine months | No | |
| Secondary | Reduction in other immunosuppressant drugs | One week through nine months | No | |
| Secondary | Ability to induce a remission in uveitis | one week through nine months | No | |
| Secondary | Duration of remission in uveitis | one week through nine months | No | |
| Secondary | Ability to re-induce a remission if a flare-up occurs | One week through nine months | No |