38 Week Extension Study to CAIN457C2303 (SHIELD)

January 22, 2016 updated by: Novartis Pharmaceuticals

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)

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Novartis Investigative Site
  • France
      • Grenoble, France, 38043
        • Novartis Investigative Site
  • Germany
      • Heidelberg, Germany, 69120
        • Novartis Investigative Site
  • Greece
      • Patras, Greece, 26500
        • Novartis Investigative Site
    • GR
      • Athens, GR, Greece, 115 27
        • Novartis Investigative Site
      • Ioannina, GR, Greece, 455 00
        • Novartis Investigative Site
      • Larissa, GR, Greece, 41110
        • Novartis Investigative Site
  • Hong Kong
      • Hongkong, Hong Kong
        • Novartis Investigative Site
  • Israel
      • Ramat Gan, Israel, 52621
        • Novartis Investigative Site
      • Tel-Aviv, Israel, 64239
        • Novartis Investigative Site
  • Jordan
      • Amman, Jordan, 11195
        • Novartis Investigative Site
  • Korea, Republic of
    • Korea
      • Seoul, Korea, Korea, Republic of, 120-752
        • Novartis Investigative Site
      • Seoul, Korea, Korea, Republic of, 110 744
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 308433
        • Novartis Investigative Site
  • Spain
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Novartis Investigative Site
      • Barcelona, Catalunya, Spain, 08028
        • Novartis Investigative Site
  • Taiwan
      • Lin-Ko, Taiwan, 33305
        • Novartis Investigative Site
  • Tunisia
      • Sfax, Tunisia
        • Novartis Investigative Site
  • Turkey
      • Altindag / Ankara, Turkey, 06590
        • Novartis Investigative Site
      • Ankara, Turkey, 06100
        • Novartis Investigative Site
      • Ankara, Turkey, 06490
        • Novartis Investigative Site
      • Fatih / Istanbul, Turkey, 34098
        • Novartis Investigative Site
      • Istanbul, Turkey, 34093
        • Novartis Investigative Site
      • Izmir, Turkey, 35380
        • Novartis Investigative Site
  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205-2005
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo AIN457
Placebo to AIN457
Experimental: AIN457 300 mg every 2 weeks
Drug: AIN457
300mg every 4 weeks
Drug: AIN457
300mg every 2 weeks
Experimental: AIN457 300 mg monthly
Drug: AIN457
300mg every 4 weeks
Drug: AIN457
300mg every 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 .
62 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

March 24, 2010

First Submitted That Met QC Criteria

March 24, 2010

First Posted (Estimate)

March 26, 2010

Study Record Updates

Last Update Posted (Estimate)

February 22, 2016

Last Update Submitted That Met QC Criteria

January 22, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAIN457C2303E1
  • 2009-013901-33

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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