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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 [20 Associated Clinical Trials listed on BioPortfolio]

Efficacy, Safety and Tolerability of BAF312 Compared to Placebo in Patients With Intracerebral Hemorrhage (ICH)

This is a randomized, placebo-controlled, subject- and investigator-blinded trial of BAF312 in intracerebral hemorrhage (ICH) patients to study efficacy, safety, and tolerability. BAF312 i...

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. ...

PubMed Articles [19 Associated PubMed Articles listed on BioPortfolio]

Cluster Analysis Using Anti-Aminoacyl-tRNA Synthetases and SS-A/Ro52 antibodies in Patients With Polymyositis/Dermatomyositis.

Although several autoantibodies have been identified for polymyositis/dermatomyositis (PM/DM) diagnosis, the clinical impact of these antibodies is yet to be elucidated.

Hospitalization mortality and associated risk factors in patients with polymyositis and dermatomyositis: A retrospective case-control study.

Polymyositis and dermatomyositis (PM/DM) are systemic autoimmune diseases with multiple organ involvements that manifest as muscular and cutaneous disorders, interstitial lung disease (ILD) and malign...

Malignancy in a retrospective cohort of 17 patients with Dermatomyositis or Polymyositis in southern Tunisia.

The prognosis of dermatomyositis (DM)/polymyositis (PM) in adults is partly related to their association with neoplasia. The aim of our study was to report the epidemiologic, clinical, paraclinical, t...

Respiratory insufficiency from myasthenia gravis and polymyositis due to malignant thymoma triggering Takotsubo syndrome.

Takotsubo syndrome (TTS) is a non-ischemic cardiomyopathy with sudden but transient systolic dysfunction. TTS mimics myocardial infarction clinically, chemically, and electrocardiographically but echo...

Musculoskeletal Manifestations of Non-RA Connective Tissue Diseases: Scleroderma, Systemic Lupus Erythematosus, Still's Disease, Dermatomyositis/Polymyositis, Sjögren's Syndrome, and Mixed Connective Tissue Disease.

The most common systemic rheumatologic conditions are connective tissue diseases (including rheumatoid arthritis [RA]) followed by spondyloarthropathy. With the advent of biotherapies and imaging biom...

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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