Trial record 2 of 27 for:    Open Studies | "Polymyositis"

Efficacy and Tolerability of BAF312 in Patients With Polymyositis

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01801917
First received: February 1, 2013
Last updated: July 6, 2016
Last verified: July 2016
  Purpose
This study will assess the efficacy, safety and tolerability of BAF312 administered orally in patients with clinically active polymyositis and also in patients with 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, Caregiver, Investigator, Outcomes Assessor)
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:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Combined efficacy endpoint: Manual Muscle Testing (MMT) and serum creatine kinase (CK) levels, or other enzymes, or MRI/biopsy if enzymes are normal. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Assessment of preliminary clinical efficacy of 2mg and 10mg BAF312 once daily using MMT of 24 muscles (MMT-24) and serum CK levels, or other enzymes, or MRI/biopsy if enzymes are normal.


Secondary Outcome Measures:
  • Adverse Events (AEs), 6 minute walking distance test (MWD) and pharmacokinetics [ Time Frame: 24 weeks for AEs and 12 weeks for 6MWD ] [ Designated as safety issue: Yes ]
    Number of adverse events will be tabulated by body systems and treatment. Distance traveled over a 6 minute time period will be measured. Steady state pharmacokinetics of BAF312 will be characterized.


Estimated Enrollment: 45
Study Start Date: April 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Experimental: BAF312 2mg
BAF312 2 mg
Drug: BAF312
Experimental: BAF312 10 mg
BAF312 10 mg
Drug: BAF312

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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, or other enzymes, or MRI/biopsy if enzymes are normal, and persisting muscle weakness
  • 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
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 ClinicalTrials.gov identifier: NCT01801917

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

Locations
United States, Arizona
Novartis Investigative Site Recruiting
Phoenix, Arizona, United States, 85013
United States, California
Novartis Investigative Site Recruiting
Los Angeles, California, United States, 90095
Novartis Investigative Site Recruiting
Orange, California, United States, 92868
United States, Florida
Novartis Investigative Site Recruiting
Miami, Florida, United States, 33136
Novartis Investigative Site Recruiting
Tampa, Florida, United States, 33612
United States, Kansas
Novartis Investigative Site Recruiting
Kansas City, Kansas, United States, 66160
United States, Massachusetts
Novartis Investigative Site Recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
Novartis Investigative Site Recruiting
Ann Arbor, Michigan, United States, 48109
Belgium
Novartis Investigative Site Completed
Leuven, Belgium, 3000
Canada, Ontario
Novartis Investigative Site Recruiting
Torono, Ontario, Canada, M5G 2C4
Canada, Quebec
Novartis Investigative Site Withdrawn
Montreal, Quebec, Canada, H2W 156
Czech Republic
Novartis Investigative Site Recruiting
Prague 2, Czech Republic, 128 50
Hungary
Novartis Investigative Site Recruiting
Budapest, Hungary, 1083
Novartis Investigative Site Recruiting
Debrecen, Hungary, 4032
Poland
Novartis Investigative Site Recruiting
Bialystok, Poland, 15-879
Novartis Investigative Site Recruiting
Bydgoszcz, Poland, 85-168
Novartis Investigative Site Recruiting
Lublin, Poland, 20-607
Switzerland
Novartis Investigative Site Recruiting
Zürich, Switzerland, 8091
Taiwan
Novartis Investigative Site Recruiting
Taichung, Taiwan, 40447
Novartis Investigative Site Recruiting
Taichung, Taiwan, 40705
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01801917     History of Changes
Other Study ID Numbers: CBAF312X2205 
Study First Received: February 1, 2013
Last Updated: July 6, 2016
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
Belgium: Federal Agency for Medicinal Products and Health Products
Taiwan: Center for Drug Evaluation
Switzerland: Swissmedic

Keywords provided by Novartis:
Polymyositis, Myositis, PM

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

ClinicalTrials.gov processed this record on July 25, 2016