Study Stopped
Core Study in Behcet's disease with mostly active uveitis did not meet its primary endpoint
38 Week Extension Study to CAIN457C2303
SHIELD
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)
2 other identifiers
interventional
59
13 countries
19
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2010
Shorter than P25 for phase_3
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 24, 2010
CompletedFirst Posted
Study publicly available on registry
March 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedResults Posted
Study results publicly available
February 22, 2016
CompletedFebruary 22, 2016
January 1, 2016
10 months
March 24, 2010
February 12, 2015
January 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
Study Arms (3)
AIN457 300 mg every 2 weeks
EXPERIMENTALAIN457 300 mg monthly
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Novartis Investigative Site
Baltimore, Maryland, 21205-2005, United States
Novartis Investigative Site
Alexandria, Egypt
Novartis Investigative Site
Grenoble, 38043, France
Novartis Investigative Site
Heidelberg, 69120, Germany
Novartis Investigative Site
Athens, GR, 115 27, Greece
Novartis Investigative Site
Ioannina, GR, 455 00, Greece
Novartis Investigative Site
Larissa, GR, 41110, Greece
Novartis Investigative Site
Pátrai, 26500, Greece
Novartis Investigative Site
Hong Kong, Hong Kong, Hong Kong
Novartis Investigative Site
Ramat Gan, 52621, Israel
Novartis Investigative Site
Tel Aviv, 64239, Israel
Novartis Investigative Site
Amman, 11195, Jordan
Novartis Investigative Site
Singapore, Singapore, 308433, Singapore
Novartis Investigative Site
Seoul, Korea, 110 744, South Korea
Novartis Investigative Site
Seoul, Korea, 120-752, South Korea
Novartis Investigative Site
Barcelona, Catalonia, 08028, Spain
Novartis Investigative Site
Barcelona, Catalonia, 08035, Spain
Novartis Investigative Site
Lin-Ko, 33305, Taiwan
Novartis Investigative Site
Sfax, Tunisia
Novartis Investigative Site
Ankara, Turkey, 06100, Turkey (Türkiye)
Novartis Investigative Site
Ankara, Turkey, 06490, Turkey (Türkiye)
Novartis Investigative Site
Altindag / Ankara, 06590, Turkey (Türkiye)
Novartis Investigative Site
Fatih / Istanbul, 34098, Turkey (Türkiye)
Novartis Investigative Site
Istanbul, 34093, Turkey (Türkiye)
Novartis Investigative Site
Izmir, 35380, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to early termination of the study AIN457C2303E1, the analysis of extension period was changed. No efficacy analyses were completed, the safety analyses were reduced to summary of AEs occurred during the extension and safety follow-up periods.
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2010
First Posted
March 26, 2010
Study Start
March 1, 2010
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
February 22, 2016
Results First Posted
February 22, 2016
Record last verified: 2016-01