Phase III Study in Refractory Behcet's Disease

NCT00995709 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2015-08-31

Study results available
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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

  • Behcet Disease

Interventions

DRUG

AIN457

DRUG

AIN457

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States
  • Egypt
  • France
  • Germany
  • Greece
  • Hong Kong
  • India
  • Israel
  • Italy
  • Jordan
  • Singapore
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Tunisia
  • Turkey (Türkiye)

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00995709 on ClinicalTrials.gov