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Safety and Efficacy of AIN457 in Noninfectious Uveitis

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: May 23, 2008
Last updated: November 18, 2013
Last verified: November 2013
This study will test the efficacy and safety of AIN457 for patients with active uveitis that requires systemic immunosuppression.

Condition Intervention Phase
Active Uveitis That is Not From an Infection. Drug: AIN457 subcutaneous dose Drug: AIN457 low dose (i.v) Drug: AIN457 high dose (i.v) Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Safety assessments will include ocular examinations, physical examination, and adverse events [ Time Frame: Baseline day through nine months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 79
Study Start Date: June 2008
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AIN457 subcutaneous dose
Experimental: 2 Drug: AIN457 low dose (i.v)
Experimental: 3 Drug: AIN457 high dose (i.v)


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00685399

  Show 28 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00685399     History of Changes
Other Study ID Numbers: CAIN457A2208
2011-001243-67 ( EudraCT Number )
Study First Received: May 23, 2008
Last Updated: November 18, 2013

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Sympathetic ophthalmia,
Multifocal choroiditis,
Birdshot retinochoroiditis,
Retinal vasculitis,
Intermediate uveitis,
Posterior uveitis

Additional relevant MeSH terms:
Uveal Diseases
Eye Diseases processed this record on June 21, 2017