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Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis

2014-07-23 21:08:43 | BioPortfolio

Summary

This study will determine the efficacy, safety, tolerability and the PK profile of BAF312, a novel immunomodulator, in polymyositis and dermatomyositis patients that are not responsive to traditional immunosuppressive and/or corticosteroid therapy. The study will consist of a 12 week, randomized, placebo controlled period, followed by another 12 weeks where all subjects will receive BAF312 treatment.

Study Design

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

Conditions

Polymyositis

Intervention

BAF312, BAF312

Location

Brigham Women's Hospital
Boston
Massachusetts
United States
02115

Status

Recruiting

Source

Novartis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:43-0400

Clinical Trials [15 Associated Clinical Trials listed on BioPortfolio]

Mechanistic Studies of Phase III Trial With BAF312 in Secondary Progressive Multiple Sclerosis

The primary goal of this study is to evaluate the effects of BAF312 (siponimod) on select immune and neuronal (nerve) cells by examining laboratory specimens (blood and/or spinal fluid) at...

Safety, Tolerability, Efficacy and Optimal Dose Finding Study of BAF312 in Patients With Relapsing-remitting Multiple Sclerosis

The purpose of this study is to determine the dose-response curve for the MRI-based efficacy of BAF312 compared with placebo in patients with Relapsing-Remitting Multiple Sclerosis (RRMS),...

Study of the Prevalence of Polymyositis and Dermatomyositis in Normandy

Polymyositis and dermatomyositis are characterized by the association to a myopathic syndrome, inflammatory infiltrates in the skeletal muscle. They remain, even today, an important factor...

myoARRAY and TcLandscape Analysis for the Diagnosis of Inflammatory Myopathies

The diagnosis of the different forms of inflammatory myopathies (polymyositis, dermatomyositis, inclusion-body myositis...) remains difficult which may lead to unappropriate patient care. ...

Methimazole to Treat Polymyositis and Dermatomyositis

This study will test the safety and effectiveness of the drug methimazole in treating polymyositis and dermatomyositis-inflammatory muscle diseases causing weakness and muscle wasting. Al...

PubMed Articles [20 Associated PubMed Articles listed on BioPortfolio]

Safety and Efficacy of Siponimod (BAF312) in Patients With Relapsing-Remitting Multiple Sclerosis: Dose-Blinded, Randomized Extension of the Phase 2 BOLD Study.

This dose-blinded extension of the phase 2 BOLD (BAF312 on MRI Lesion Given Once Daily) Study in relapsing-remitting multiple sclerosis provides evidence on disease activity and safety of a range of s...

Siponimod (BAF312) prevents synaptic neurodegeneration in experimental multiple sclerosis.

Data from multiple sclerosis (MS) and the MS rodent model, experimental autoimmune encephalomyelitis (EAE), highlighted an inflammation-dependent synaptopathy at the basis of the neurodegenerative dam...

The risk of cancer in patients with connective tissue diseases but without dermatomyositis or polymyositis: a multicenter cohort study conducted over 15 years in China.

To investigate the relative risk of cancer in Chinese patients with connective tissue diseases (CTD) associated with and without dermatomyositis or polymyositis.

Fatty acid binding protein 3 is associated with skeletal muscle strength in polymyositis and dermatomyositis.

To determine serum levels and histopathological characteristics of fatty acid binding protein 3 (FABP3) in patients with polymyositis (PM) and dermatomyositis (DM), and to evaluate the correlation bet...

HMGB1 May Be a Biomarker for Predicting the Outcome in Patients with Polymyositis /Dermatomyositis with Interstitial Lung Disease.

To investigate the significance of high mobility group box 1 (HMGB1) levels in polymyositis (PM) and dermatomyositis (DM) patients with interstitial lung disease and whether HMGB1 levels could predict...

Medical and Biotech [MESH] Definitions

Diseases characterized by inflammation involving multiple muscles. This may occur as an acute or chronic condition associated with medication toxicity (DRUG TOXICITY); CONNECTIVE TISSUE DISEASES; infections; malignant NEOPLASMS; and other disorders. The term polymyositis is frequently used to refer to a specific clinical entity characterized by subacute or slowly progressing symmetrical weakness primarily affecting the proximal limb and trunk muscles. The illness may occur at any age, but is most frequent in the fourth to sixth decade of life. Weakness of pharyngeal and laryngeal muscles, interstitial lung disease, and inflammation of the myocardium may also occur. Muscle biopsy reveals widespread destruction of segments of muscle fibers and an inflammatory cellular response. (Adams et al., Principles of Neurology, 6th ed, pp1404-9)

A syndrome with overlapping clinical features of systemic lupus erythematosus, scleroderma, polymyositis, and Raynaud's phenomenon. The disease is differentially characterized by high serum titers of antibodies to ribonuclease-sensitive extractable (saline soluble) nuclear antigen and a "speckled" epidermal nuclear staining pattern on direct immunofluorescence.

Autoantibodies directed against various nuclear antigens including DNA, RNA, histones, acidic nuclear proteins, or complexes of these molecular elements. Antinuclear antibodies are found in systemic autoimmune diseases including systemic lupus erythematosus, Sjogren's syndrome, scleroderma, polymyositis, and mixed connective tissue disease.

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