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

2014-08-27 03:18:39 | BioPortfolio

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.

Study Design

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

Conditions

Behcet Disease

Intervention

AIN457, AIN457, Placebo

Location

Denver Health Medical Center
Denver
Colorado
United States
80204

Status

Active, not recruiting

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:39-0400

Clinical Trials [259 Associated Clinical Trials listed on BioPortfolio]

Efficacy of AIN457 in Adults (18-65 Years) With Moderate to Severe Ankylosing Spondylitis

This study is designed as a proof of concept of AIN457 in patients with ankylosing spondylitis. The study will address the evaluation of the efficacy at 6 and up to 28 weeks after two dose...

Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)

This study will assess at Week 16 the efficacy and safety of AIN457 at different doses in patients with active RA despite stable MTX therapy. Treatment will continue up to Week 48 with a s...

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...

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.

AIN457 Regimen Finding Study in Patients With Moderate to Severe Psoriasis

The purpose of the study is to determine whether, in patients with moderate to severe plaque-type psoriasis, AIN457 administered subcutaneously reduces the severity of psoriasis symptoms a...

PubMed Articles [15181 Associated PubMed Articles listed on BioPortfolio]

Circulating immune complexome analysis identified anti-tubulin-α-1c as an inflammation associated autoantibody with promising diagnostic value for Behcet's Disease.

Behcet's disease (BD) is a chronic, multisystem-involved vasculitis and its pathogenesis remains elusive. No specific serological markers for BD diagnosis have been established. Identification of nove...

Recurrent Iliofemoral Venous Thrombosis in the Setting of May-Thurner Syndrome as the Presenting Symptom of Behcet's Disease.

Vascular manifestations including pulmonary artery aneurysms and venous thrombosis are seen in up to 14% of patients with Behcet's Disease. We report a patient who had recurrent deep vein thrombosis (...

Association of and with ocular Behcet's disease in a Chinese Han population.

An Immunochip study recently identified the association of a number of new genetic loci with Behcet's disease (BD).

Treatment of the Median Arcuate Ligament Syndrome in a Patient With Behcet's Disease Median Arcuate Ligament Syndrome accompanying to Behcet's disease.

Compression of the celiac artery by the median arcuate ligament (MAL) and neurofibrous tissue is called MAL syndrome or Dunbar's syndrome. Postprandial abdominal pain, weight loss are the main symptom...

Association of Long Noncoding RNAs Polymorphisms With Ankylosing Spondylitis, Vogt-Koyanagi-Harada Disease, and Behcet's Disease.

Long noncoding RNAs (lncRNAs) are emerging as important regulators of inflammatory immune responses, whereby genetic variants may affect this biologic function. This study aimed to investigate the ass...

Medical and Biotech [MESH] Definitions

Inflammation of the retinal vasculature with various causes including infectious disease; LUPUS ERYTHEMATOSUS, SYSTEMIC; MULTIPLE SCLEROSIS; BEHCET SYNDROME; and CHORIORETINITIS.

Rare chronic inflammatory disease involving the small blood vessels. It is of unknown etiology and characterized by mucocutaneous ulceration in the mouth and genital region and uveitis with hypopyon. The neuro-ocular form may cause blindness and death. SYNOVITIS; THROMBOPHLEBITIS; gastrointestinal ulcerations; RETINAL VASCULITIS; and OPTIC ATROPHY may occur as well.

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.

Animate or inanimate sources which normally harbor disease-causing organisms and thus serve as potential sources of disease outbreaks. Reservoirs are distinguished from vectors (DISEASE VECTORS) and carriers, which are agents of disease transmission rather than continuing sources of potential disease outbreaks.

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