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Safety and Efficacy of AIN457 in Behçet's Patients With Posterior or Panuveitis

2014-07-23 21:09:44 | BioPortfolio

Summary

The purpose of this extension trial is to provide patients with an opportunity to receive an additional 26 weeks of treatment yielding safety and efficacy data for AIN457 in Behçet's patients with intermediate, posterior or panuveitis and to provide a 12 week treatment-free safety follow up period.

Study Design

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

Conditions

Uveitis

Intervention

AIN457, AIN457, Placebo

Location

The Wilmer Eye Institute
Baltimore
Maryland
United States
21287

Status

Enrolling by invitation

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:44-0400

Clinical Trials [137 Associated Clinical Trials listed on BioPortfolio]

Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis

This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic immunosuppress...

Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis

This study will assess the safety and efficacy of AIN457 as adjunctive therapy for the treatment of intermediate uveitis, posterior uveitis, or panuveitis requiring systemic immunosuppress...

Extension Study to Assess Safety and Efficacy of AIN457 in Patients With Active Non-infectious Uveitis

The purpose of the extension study is to provide patients completing the 28-week core study with an opportunity to receive an additional 22 weeks of continuous treatment.

Safety and Efficacy of AIN457 in Behçet's Patients With Posterior or Panuveitis

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 Behç...

Safety and Efficacy of AIN457 in Patients With Quiescent Non-infectious Uveitis Study

The extension study will serve to provide patients completing the 24 week core study with an opportunity to receive additional 26 weeks of continuous treatment. It will also provide 12-we...

PubMed Articles [1017 Associated PubMed Articles listed on BioPortfolio]

Use of Gevokizumab in Patients with Behçet's Disease Uveitis: An International, Randomized, Double-Masked, Placebo-Controlled Study and Open-Label Extension Study.

The purpose of this article is to demonstrate the superiority of gevokizumab as compared to placebo, on top of current standard of care, in reducing the risk of Behçet's disease uveitis (BDU) exacerb...

ADJUVITE: a double-blind, randomised, placebo-controlled trial of adalimumab in early onset, chronic, juvenile idiopathic arthritis-associated anterior uveitis.

To assess the efficacy and safety of adalimumab on uveitis in patients with early onset, chronic, juvenile idiopathic arthritis (JIA)-associated or idiopathic anterior uveitis and an inadequate respon...

Simvastatin as an Adjunct to Conventional Therapy of Non-infectious Uveitis: A Randomized, Open-Label Pilot Study.

Statins have been shown to reduce ocular inflammation in animal models of uveitis and to prevent development of uveitis in observational studies. There have been no experimental human studies evaluati...

An amino acid motif in HLA-DRβ1 distinguishes patients with uveitis in juvenile idiopathic arthritis.

Uveitis is a visually-debilitating disorder that affects up to 30% of children with the most common forms of juvenile idiopathic arthritis (JIA). The disease mechanisms predisposing only a subgroup of...

Uveitis Referral Pattern in Upper and Lower Egypt.

To report the pattern of uveitis in two referral eye hospitals, one in Upper Egypt and another in Lower Egypt Methods: Retrospective chart review of all uveitis cases visiting the uveitis clinic in Al...

Medical and Biotech [MESH] Definitions

Human histocompatibility (HLA) surface antigen encoded by the B locus on chromosome 6. It is strongly associated with acute anterior uveitis (UVEITIS, ANTERIOR); ANKYLOSING SPONDYLITIS; and REACTIVE ARTHRITIS.

Inflammation of the choroid as well as the retina and vitreous body. Some form of visual disturbance is usually present. The most important characteristics of posterior uveitis are vitreous opacities, choroiditis, and chorioretinitis.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.

Inflammation of the pars plana, ciliary body, and adjacent structures.

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