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Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01148810
First Posted: June 22, 2010
Last Update Posted: August 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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 (Participant, 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:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

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

Secondary Outcome Measures:
  • Measure: Safety and tolerability using safety assessments [ Time Frame: 12 weeks ]
  • Measure: Characterize the steady state pharmacokinetics [ Time Frame: 12 weeks ]
  • Measure: Exposure effect on safety and efficacy parameters [ Time Frame: 12 weeks ]
  • Measure: Biomarkers reflecting efficacy in reducing systemic inflammation [ Time Frame: 12 weeks ]
  • Measure: Efficacy in modifying health-related quality of life measured by SF-36 [ Time Frame: 12 weeks ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01148810     History of Changes
Other Study ID Numbers: CBAF312A2202
2008-006311-21 ( EudraCT Number )
First Submitted: June 21, 2010
First Posted: June 22, 2010
Last Update Posted: August 1, 2013
Last Verified: July 2013

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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


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