NCT01093846

38 Week Extension Study to CAIN457C2303

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)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Conditions

• Uveitis

Interventions

Type	Name	Description
DRUG	AIN457	300mg every 4 weeks
DRUG	AIN457	300mg every 2 weeks
DRUG	Placebo AIN457	Placebo to AIN457

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-03-26
• Last updated: 2016-02-22
• Results posted: 2016-02-22

Locations

25 sites across 14 countries: United States, Egypt, France, Germany, Greece, Hong Kong, Israel, Jordan, Singapore, South Korea, Spain, Taiwan, Tunisia, Turkey (Türkiye)