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Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis (ENDURE)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01090310
First received: March 18, 2010
Last updated: December 8, 2015
Last verified: December 2015
  Purpose
This extension study will assess the safety and efficacy of AIN457 versus placebo for maintaining uveitis suppression when reducing systemic immunosuppression

Condition Intervention Phase
Non-infectious Uveitis
Drug: AIN457
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 38-week Extension to a 24-week Multicenter, Randomized, Double-masked, Placebo Controlled, Dose-ranging Phase III Study of AIN457 Versus Placebo for Maintaining Uveitis Suppression When Reducing Systemic Immunosuppression in Patients With Quiescent, Non-infectious Intermediate, Posterior or Panuveitis

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • The Time to the First Recurrence in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline [ Time Frame: Baseline to 52 weeks ] [ Designated as safety issue: No ]
    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:
  • Change in Vitreous Haze Score for the Study Eye From Baseline to the Highest Post-baseline Value [ Time Frame: Baseline to 52 weeks ] [ Designated as safety issue: No ]
    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

  • Mean Change in Best Corrected Visual Acuity From Baseline, Core and Extension [ Time Frame: Baseline to 52 weeks ] [ Designated as safety issue: No ]
    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

  • Number of Participants With First Recurrence in in Any Eye of Active Intermediate, Posterior, or Panuveitis From Baseline During the Core and Extension Studies [ Time Frame: Baseline to 52 weeks ] [ Designated as safety issue: No ]
    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

  • Composite Immunosuppressive Medication Score From Baseline to Week 52, Core and Extension [ Time Frame: Baseline to 52 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 86
Study Start Date: August 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIN457 300mg every 2 weeks
AIN457 300 mg subcutaneous (s.c.) weekly for 3 weeks followed by AIN457 300 mg s.c. every 2 weeks
Drug: AIN457
AIN457 150 mg powder for solution was provided in glass vials each containing 150 mg AIN457 as a lyophilized cake
Experimental: AIN457 300 mg every 4 weeks
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
Drug: AIN457
AIN457 150 mg powder for solution was provided in glass vials each containing 150 mg AIN457 as a lyophilized cake
Experimental: AIN457 150 mg every 4 weeks
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
Drug: AIN457
AIN457 150 mg powder for solution was provided in glass vials each containing 150 mg AIN457 as a lyophilized cake
Placebo Comparator: Placebo
Placebo s.c. every 2 weeks
Drug: Placebo
Matching placebo to AIN457

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have completed the entire treatment period of the 24 week core study

Exclusion Criteria:

  • 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.

  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 ClinicalTrials.gov identifier: NCT01090310

  Show 35 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01090310     History of Changes
Other Study ID Numbers: CAIN457C2301E1  2009-015508-24 
Study First Received: March 18, 2010
Results First Received: February 12, 2015
Last Updated: December 8, 2015
Health Authority: United States: Food and Drug Administration
Switzerland: Swissmedic
Germany: Paul-Ehrlich-Institut
Spain: Spanish Agency of Medicines
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Brazil: National Health Surveillance Agency
India: Ministry of Health
Israel: Ministry of Health

Keywords provided by Novartis:
Quiescent uveitis
intermediate uveitis
panuveitis
posterior uveitis
uveitis
NVS Definition: Words or phrases that best describe the protocol. Keywords help users find studies in the database.
Avoid acronyms, abbreviations and trade names.
Examples: Heart failure, aliskiren, heart attack, cardiovascular diseases
Psoriasis, inflammatory skin disease, scaly patches

Additional relevant MeSH terms:
Uveitis
Uveal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on December 06, 2016