Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis
- Registration Number
- NCT01090310
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This extension study will assess the safety and efficacy of AIN457 versus placebo for maintaining uveitis suppression when reducing systemic immunosuppression
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 86
- Patients who have completed the entire treatment period of the 24 week core study
- Inability or unwillingness to undergo repeated subcutaneous injections; inability to comply with study or follow-up procedures; any medical or psychiatric condition which, in the investigator's opinion wouldpreclude the participant from adhering to the protocol or completing the study per protocol.
Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AIN457 300mg every 2 weeks AIN457 AIN457 300 mg subcutaneous (s.c.) weekly for 3 weeks followed by AIN457 300 mg s.c. every 2 weeks AIN457 300 mg every 4 weeks AIN457 AIN457 300 mg s.c. at baseline for Week 2 followed by AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly Placebo Placebo Placebo s.c. every 2 weeks AIN457 150 mg every 4 weeks AIN457 AIN457 150 mg s.c. and placebo s.c. at Baseline and Week 2 followed by AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
- Primary Outcome Measures
Name Time Method The Time to the First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline Baseline to 52 weeks Kaplan-Meier estimates for the time to the first recurrence in any eye of active intermediate, posterior, or panuveitis from baseline defined by either: ≥ 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity, core and extension
- Secondary Outcome Measures
Name Time Method Change in Vitreous Haze Score for the Study Eye From Baseline to the Highest Post-baseline Value Baseline to 52 weeks The changes in steps (0, 1, or \>= 2) from previous visit for vitreous haze, where the score is evaluated based on NEI Vitreous Haze Grading Scale (0 -4). Vitreous haze was recorded as 0-clear; to 4+ as dense opacity obscuring the optic nerve head. A 1 step increase is defined as any of the following changes: 0-1, 0.5-1, 1-2, 2-3, 3-4. A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4. A recurrent episode of active intermediate, posterior or panuveitis was considered to be resolved, if the eye returns and maintains in a quiescent state (\<1+ anterior chamber cell grade and \<1+ vitreous haze) for at least 2 weeks
Number of Participants With First Recurrence in in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline During the Core and Extension Studies Baseline to 52 weeks Evaluation of recurrence until resolution is ascertained, based on the first criteria (a \>2 step increase in vitreous haze with or without an increase in anterior chamber cell grade in either eye). A 2 step increase is defined as any of the following changes: 0-2, 0.5-2, 1-3, 2-4
Mean Change in Best Corrected Visual Acuity From Baseline, Core and Extension Baseline to 52 weeks The Best Corrected Visual Acuity (BCVA) is tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements are taken in a sitting position at an initial test distance of 4 meters using ETDRS charts. The overall BCVA score is calculated using the BCVA worksheet 0-100 letter score
Composite Immunosuppressive Medication Score From Baseline to Week 52, Core and Extension Baseline to 52 weeks IMS is a combined, single numeric score derived on the basis of the total daily dose of specific immunosuppressive agents per unit body weight, ranged on a scale from 0 to 9 for the total daily dose in milligrams per kilogram. The total IMS is the sum of the scores derived for the agents included into the score. The treatment groups will be compared using an analysis of covariance with treatment, region, and baseline IMS as covariate. The total IMS is the sum of scores derived from the agents included into the score, and ranged from 0 to 55. Treatment groups compared using analysis of covariance with treatment \& baseline IMS as covariate, where the lower IMS showed better clinical outcome.
Trial Locations
- Locations (1)
Novartis Investigative Site
🇬🇧York, United Kingdom