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Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01148810
First received: June 21, 2010
Last updated: February 13, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Polymyositis
Dermatomyositis
 Drug: BAF312
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-centre, Double-blind, Placebo Controlled, Proof of Concept Study to Evaluate the Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis

Resource links provided by NLM:

MedlinePlus related topics: Myositis
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure: Preliminary clinical efficacy using the IMACS core set measures [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measure: Safety and tolerability using safety assessments [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Measure: Characterize the steady state pharmacokinetics [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Measure: Exposure effect on safety and efficacy parameters [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Measure: Biomarkers reflecting efficacy in reducing systemic inflammation [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Measure: Efficacy in modifying health-related quality of life measured by SF-36 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: June 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
Experimental: BAF312 Drug: BAF312

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with disease at least 3 months before study
  • Muscle weakness
  • Received corticosteroids with or with out disease modifying antirheumatic drugs at least 3 months before study however not responding to this therapy

Exclusion Criteria:

  • Other idiopathic inflammatory myopathies
  • Myopathy other than polymyositis and dermatomyositis
  • Patients with late stages of disease Other protocol-defined inclusion/exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01148810

Locations
United States, Massachusetts
Novartis Investigative Site
Boston, Massachusetts, United States, 02115
Czech Republic
Novartis Investigative Site
Prague 2, Czech Republic, 128 50
Hungary
Novartis Investigative Site
Budapest, Hungary, 1083
Novartis Investigative Site
Debrecen, Hungary, 4032
Sweden
Novartis Investigative Site
Stockholm, Sweden, 17176
United Kingdom
Novartis Investigative Site
Manchester, United Kingdom, M6 8HD
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01148810     History of Changes
Other Study ID Numbers: CBAF312A2202, 2008-006311-21
Study First Received: June 21, 2010
Last Updated: February 13, 2013
Health Authority: United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Novartis:
Inflammatory muscle disease
Muscle weakness
Myositis

Additional relevant MeSH terms:
Dermatomyositis
Polymyositis
Myositis
Muscular Diseases
Musculoskeletal Diseases
 Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013