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Trial record 16 of 26 for:    Open Studies | "Myositis"
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Efficacy and Tolerability of BAF312 in Patients With Polymyositis

This study is currently recruiting participants.
Verified May 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01801917
First received: February 1, 2013
Last updated: May 10, 2013
Last verified: May 2013
History of Changes
  Purpose

This study will assess the efficacy, safety and tolerability of BAF312 administered orally in patients with clinically active polymyositis who have shown inadequate response to corticosteroids and or DMARDs (disease modifying antirheumatic drugs).


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Myositis
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Combined efficacy endpoint: Manual Muscle Testing (MMT) and serum creatine kinase (CK) levels [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Assessment of preliminary clinical efficacy of 2mg BAF312 once daily using MMT of 8 muscles (MMT-8) and serum CK levels


Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Number of adverse events will be tabulated by body systems and treatment.


Estimated Enrollment: 30
Study Start Date: April 2013
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Experimental: BAF312
Active drug
 Drug: BAF312
Patients randomized to active treatment will undergo a titration period of 6 days with BAF312. From day 6 patients will receive BAF312 (2 mg) for the entire duration of Period 1. Both patients randomized on active and on placebo will be offered to enter in the all-active extension Period 2, after the completion of Period 1.

  Eligibility

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

Inclusion Criteria:

  • "definite" or "probable" for polymyositis at least three months before Baseline
  • active disease as defined by elevated CK levels and persisting muscle weakness
  • must have received and inadequately responding to standard therapies (corticosteroid alone or with disease modifying antirheumatic drugs
  • stable dose of corticosteroid for at least 2 weeks prior to Baseline and should not have received a medium or high dose in the last 8 weeks prior to study entry.
  • patients treated with methotrexate must have been on a stable dose for at least 6 weeks prior to Baseline.

Exclusion Criteria:

  • Patients with overlap polymyositis, late-stage polymyositis, or other types of myositis.

    • Preexisting severe cardiac or pulmonary involvement, malignancy of any organ system or significant eye diseases.
    • Uncontrolled diabetes mellitus or diabetes complicated with organ involvement.
    • Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01801917

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals

Locations
United States, Arizona
Novartis Investigative Site Not yet recruiting
Phoenix, Arizona, United States, 85013
United States, Florida
Novartis Investigative Site Not yet recruiting
Miami, Florida, United States, 33101
United States, Massachusetts
Novartis Investigative Site Not yet recruiting
Boston, Massachusetts, United States, 02115
United States, Pennsylvania
Novartis Investigative Site Not yet recruiting
Pittsburgh, Pennsylvania, United States
Canada, Alberta
Novartis Investigative Site Not yet recruiting
Calgary, Alberta, Canada, T3B 0M3
Novartis Investigative Site Not yet recruiting
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
Novartis Investigative Site Withdrawn
Hamilton, Ontario, Canada, L8N 3Z5
Canada, Quebec
Novartis Investigative Site Withdrawn
Montreal, Quebec, Canada, H2L 4M1
Novartis Investigative Site Not yet recruiting
Montreal, Quebec, Canada, H2W 156
Canada
Novartis Investigative Site Withdrawn
Toronto, Canada, M5G 2C4
Novartis Investigative Site Not yet recruiting
Toronto, Canada
Czech Republic
Novartis Investigative Site Not yet recruiting
Prague 2, Czech Republic, 128 50
Hungary
Novartis Investigative Site Not yet recruiting
Budapest, Hungary, 1083
Novartis Investigative Site Recruiting
Debrecen, Hungary, 4032
Poland
Novartis Investigative Site Not yet recruiting
Bialystok, Poland, 15-461
Novartis Investigative Site Not yet recruiting
Bydgoszcz, Poland, 85-168
Novartis Investigative Site Not yet recruiting
Lublin, Poland, 20-607
Novartis Investigative Site Withdrawn
Poznan, Poland, 60-773
Novartis Investigative Site Not yet recruiting
Szczecin, Poland, 71-252
Novartis Investigative Site Not yet recruiting
Warsaw, Poland, 02-637
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: NCT01801917     History of Changes
Other Study ID Numbers: CBAF312X2205
Study First Received: February 1, 2013
Last Updated: May 10, 2013
Health Authority: Canada: Health Canada
United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Poland: Ministry of Health

Keywords provided by Novartis:
Polymyositis, Myositis

Additional relevant MeSH terms:
Polymyositis
Myositis
Muscular Diseases
 Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013