Clinical Trials Directory

Trials / Completed

CompletedNCT00995709

Phase III Study in Refractory Behcet's Disease

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
118 (actual)
Sponsor
Novartis Pharmaceuticals · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this pivotal trial is to evaluate subcutaneous (SQ) AIN457 as an adjunctive therapy to reduce the rate of exacerbations of posterior uveitis or panuveitis secondary to Behçet's disease during the 24 weeks of study therapy as compared to standard of care alone.

Conditions

Interventions

TypeNameDescription
DRUGAIN457
DRUGAIN457
DRUGPlacebo

Timeline

Start date
2009-10-01
Primary completion
2010-07-01
Completion
2010-07-01
First posted
2009-10-15
Last updated
2015-08-31
Results posted
2015-08-31

Locations

49 sites across 17 countries: United States, Egypt, France, Germany, Greece, Hong Kong, India, Israel, Italy, Jordan, Singapore, South Korea, Spain, Switzerland, Taiwan, Tunisia, Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT00995709. Inclusion in this directory is not an endorsement.