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Trial record 17 of 85 for:    Polymyositis AND Myopathy

Efficacy and Tolerability of BAF312 in Patients With Polymyositis and Dermatomyositis

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ClinicalTrials.gov Identifier: NCT01148810
Recruitment Status : Terminated
First Posted : June 22, 2010
Last Update Posted : August 1, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Polymyositis Dermatomyositis Drug: BAF312 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
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
Study Start Date : June 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Experimental: BAF312 Drug: BAF312



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01148810     History of Changes
Other Study ID Numbers: CBAF312A2202
2008-006311-21 ( EudraCT Number )
First Posted: June 22, 2010    Key Record Dates
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