Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis

23:29 EST 28th February 2015 | 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

Clinical Trials [12 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),...

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...

Combined Treatment of Methotrexate + Glucocorticoids Versus Glucocorticoids Alone in Patients With Polymyositis and Dermatomyositis

Therapeutical trial in patients with idiopathic polymyositis and dermatomyositis is proposed. The study will investigate the safety and efficacy of combined methotrexate + glucocorticoids ...

PubMed Articles [29 Associated PubMed Articles listed on BioPortfolio]

Impact of aging on the clinical features and treatment of polymyositis in adults.

Abstract Objectives: The aim of this long-term retrospective study was to compare the clinical features of elderly and younger polymyositis patients. Methods: The clinical records of 21 polymyositis p...

Overflow proteinuria as a manifestation of unrecognized polymyositis.

Polymyositis is a rare and gradually progressive autoimmune disease of skeletal muscle. Two main types of renal involvement have been described: acute tubular necrosis related to rhabdomyolysis and gl...

Dermatomyositis, polymyositis and immune-mediated necrotising myopathies.

Dermatomyositis, polymyositis and immune-mediated necrotising myopathy are major forms of idiopathic inflammatory myopathy. We review here recent developments in understanding of the pathology and pat...

Is Statin-Induced Myositis Part of the Polymyositis Disease Spectrum?

Statin medications have recently been shown to cause not only a toxic myopathy but also an immune-mediated necrotizing myositis. Before the discovery of a specific anti-HMG-CoA reductase antibody occu...

Risk of deep venous thrombosis and pulmonary embolism in individuals with polymyositis and dermatomyositis: a general population-based study.

Patients with polymyositis (PM) and dermatomyositis (DM) may have an increased risk of venous thromboembolism (VTE); however, no general population data are available to date. The purpose of this stud...

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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