38 Week Extension Study to CAIN457C2303

Uveitis Clinical Trial

— SHIELD  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01093846
• Other study ID #: CAIN457C2303E1
• Secondary ID: 2009-013901-33
• Status: Terminated
• Phase: Phase 3
• First received: March 24, 2010
• Last updated: January 22, 2016
• Start date: March 2010
• Est. completion date: January 2011

Study information

• Verified date: January 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 59
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uveitis

Intervention

Drug:
• AIN457
300mg every 4 weeks
• AIN457
300mg every 2 weeks
• Placebo AIN457
Placebo to AIN457

Locations

Country	Name	City	State
Egypt	Novartis Investigative Site	Alexandria
France	Novartis Investigative Site	Grenoble
Germany	Novartis Investigative Site	Heidelberg
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Ioannina	GR
Greece	Novartis Investigative Site	Larissa	GR
Greece	Novartis Investigative Site	Patras
Hong Kong	Novartis Investigative Site	Hongkong
Israel	Novartis Investigative Site	Ramat Gan
Israel	Novartis Investigative Site	Tel-Aviv
Jordan	Novartis Investigative Site	Amman
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Singapore	Novartis Investigative Site	Singapore
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
Taiwan	Novartis Investigative Site	Lin-Ko
Tunisia	Novartis Investigative Site	Sfax
Turkey	Novartis Investigative Site	Altindag / Ankara
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Fatih / Istanbul
Turkey	Novartis Investigative Site	Istanbul
Turkey	Novartis Investigative Site	Izmir
United States	Novartis Investigative Site	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Egypt,  France,  Germany,  Greece,  Hong Kong,  Israel,  Jordan,  Korea, Republic of,  Singapore,  Spain,  Taiwan,  Tunisia,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No