Trial record 10 of 64 for:    Polymyositis

Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis

This study has been terminated.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: June 21, 2010
Last updated: July 25, 2013
Last verified: July 2013
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
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:

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


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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01148810

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

Responsible Party: Novartis ( Novartis Pharmaceuticals ) Identifier: NCT01148810     History of Changes
Other Study ID Numbers: CBAF312A2202  2008-006311-21 
Study First Received: June 21, 2010
Last Updated: July 25, 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

Additional relevant MeSH terms:
Connective Tissue Diseases
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Skin Diseases processed this record on May 24, 2016