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Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis

04:03 EDT 18th April 2014 | 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

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.

Clinical Trials [11 Associated Clinical Trials listed on BioPortfolio]

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...

Resistance Exercise Reduces the Expression of Inflammation and Fibrosis Associated Genes in Autoimmune Myositis Patients

The aim of this study was to investigate the effects of physical exercise on gene expression in muscle biopsies from patients with chronic polymyositis or dermatomyositis

PubMed Articles [31 Associated PubMed Articles listed on BioPortfolio]

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...

Altered lipid levels in untreated patients with early polymyositis.

Little is known so far on the lipid profile in polymyositis (PM) patients. Our aim is to identify lipid profiles in untreated patients with early PM, to assess the association between lipid profiles a...

Hand Exercise Intervention in Patients with Polymyositis and Dermatomyositis: A Pilot Study.

The aim of the present study was to develop a 12-week hand exercise intervention for patients with polymyositis (PM) and dermatomyositis (DM) and evaluate adherence, patients' opinions of the programm...

Elevated muscle enzymes in a patient with severe hypocalcemia mimicking polymyositis.

Abstract We report a case of hypocalcemic myopathy confounded by polymyositis due to an elevated level of serum creatine kinase (CK). A 30-year-old man was referred to our hospital for the treatment o...

A case of concurrent vitiligo vulgaris and polymyositis.

Abstract  We present a rare case of simultaneous muscle weakness and cutaneous depigmentation. Muscle and skin biopsies confirmed the diagnosis of polymyositis and generalized vitiligo vulgaris. All...

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