We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Tolerability of BAF312 in Patients With Polymyositis

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01801917
First Posted: March 1, 2013
Last Update Posted: November 13, 2017
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 )
February 1, 2013
March 1, 2013
November 13, 2017
April 2013
August 2016   (Final data collection date for primary outcome measure)
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 ]
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.
Combined efficacy endpoint: Manual Muscle Testing (MMT) and serum creatine kinase (CK) levels [ Time Frame: 12 weeks ]
Assessment of preliminary clinical efficacy of 2mg BAF312 once daily using MMT of 8 muscles (MMT-8) and serum CK levels
Complete list of historical versions of study NCT01801917 on ClinicalTrials.gov Archive Site
Adverse Events (AEs), 6 minute walking distance test (MWD) and pharmacokinetics [ Time Frame: 24 weeks for AEs and 12 weeks for 6MWD ]
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.
Adverse Events [ Time Frame: 24 weeks ]
Number and percentage of adverse events will be tabulated by body systems and treatment.
Not Provided
Not Provided
 
Efficacy and Tolerability of BAF312 in Patients With Polymyositis
A Multi-centre Double-blind, Placebo Controlled, Proof of Concept Study to Evaluate the Efficacy and Tolerability of BAF312 in Patients With Polymyositis
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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Polymyositis
  • Drug: Placebo
  • Drug: BAF312
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
  • Experimental: BAF312 2mg
    BAF312 2 mg
    Intervention: Drug: BAF312
  • Experimental: BAF312 10 mg
    BAF312 10 mg
    Intervention: Drug: BAF312
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
14
August 2016
August 2016   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Czech Republic,   Hungary,   Poland,   Taiwan,   United States
Belgium,   Netherlands,   Switzerland
 
NCT01801917
CBAF312X2205
No
Not Provided
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP