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38 Week Extension Study to CAIN457C2303 (SHIELD)

This study has been terminated.
(Core Study in Behcet's disease with mostly active uveitis did not meet its primary endpoint)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01093846
First received: March 24, 2010
Last updated: January 22, 2016
Last verified: January 2016
  Purpose
A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet's patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy

Condition Intervention Phase
Uveitis
Drug: AIN457
Drug: Placebo AIN457
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 38-week Extension to a 24 Week Multicenter, Randomized, Double-masked, Placebo Controlled Study to Assess the Difference in the Rate of Recurrent Exacerbations in Behçet's Patients With Posterior or Panuveitis Treated With AIN457 vs Placebo Adjunctive to Standard-of-care Immunosuppressive Therapy (SHIELD Study)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • The Effect of Continuous Treatment With Subcutaneous AIN457 Compared to Placebo in Reducing the Rate of Recurrent Ocular Exacerbations in Behçet's Patients With Intermediate Uveitis, Posterior Uveitis or Panuveitis in Group 1. [ Time Frame: 62 weeks ] [ Designated as safety issue: No ]
    The primary objective of the study was to determine the effect of continuous treatment with subcutaneous AIN457 compared to placebo in reducing the rate of recurrent ocular exacerbations in Behçet's patients with intermediate uveitis, posterior uveitis or panuveitis in patients who completed the core study and continued treatment in the extension study (Group 1).Due to early termination of the study AIN457C2303E1, the analysis of extension period was changed. No efficacy analyses were completed, the safety analyses are available in the summary of AEs which occurred during the extension and safety follow-up periods and are shown in the safety section .


Enrollment: 59
Study Start Date: March 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIN457 300 mg every 2 weeks Drug: AIN457
300mg every 2 weeks
Experimental: AIN457 300 mg monthly Drug: AIN457
300mg every 4 weeks
Placebo Comparator: Placebo Drug: Placebo AIN457
Placebo to AIN457

  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Exclusion Criteria:

  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: NCT01093846

  Show 25 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01093846     History of Changes
Other Study ID Numbers: CAIN457C2303E1  2009-013901-33 
Study First Received: March 24, 2010
Results First Received: February 12, 2015
Last Updated: January 22, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
uveitis

Additional relevant MeSH terms:
Uveitis
Uveal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on December 02, 2016