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Safety, Tolerability and Efficacy of ACZ885 on Leg Artery Structure in Patients With Peripheral Artery Disease

This study has been terminated.
(The study got terminated based on result from primary endpoint analysis)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01731990
First Posted: November 22, 2012
Last Update Posted: September 27, 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 )
November 18, 2012
November 22, 2012
July 21, 2017
August 22, 2017
September 27, 2017
October 30, 2012
August 4, 2016   (Final data collection date for primary outcome measure)
Mean Vessel Wall Area Ratio of 12 Months to Baseline [ Time Frame: Baseline, 12 months post-dose ]
Peripheral artery wall area (superficial femoral artery) measured using Magnetic Resonance Imaging (MRI) cross-section slices. Mean vessel wall area (mm^2) was derived by converting total plaque volume (TPV) (mL) of the vessel to mm^3 by multiplying by 1000, dividing by the number of slices used for the volume calculation, and dividing by the thickness of a slice (3 mm). Least squares mean for ratio of 12 months to baseline was measured from repeated measures mixed effect model with visit, treatment, the treatment-by-visit interaction, baseline and the visit-by-baseline interaction as fixed effects.
Mean vessel wall volume [ Time Frame: 12 months ]
Peripheral artery wall area (superficial femoral artery) measured using MRI cross-section slices. Mean vessel wall volume is the average, for each MRI, over the individual slices of cross- sectional area of the vessel wall measured.
Complete list of historical versions of study NCT01731990 on ClinicalTrials.gov Archive Site
  • Number of Patients With Adverse Events in 12 Months [ Time Frame: Baseline to 12 months post-dose ]
    Summary statistics on adverse event is reported. It is categorized as number of patients in total adverse events (non serious and serious AEs), serious adverse event, death.
  • Serum Amyloid A (SAA) Level Ratio of 12 Months to Baseline [ Time Frame: Baseline, 12 months post-dose ]
    Least squares mean for ratio of 12 months to baseline was measured from repeated measures mixed effect model with visit, treatment, treatment-by-visit interaction, baseline and the visit-by-baseline interaction as fixed effects.
  • High Sensitivity C-reactive Protein (hsCRP) Ratio of 12 Months to Baseline [ Time Frame: Baseline, 12 months post-dose ]
    Least squares mean for ratio of 12 months to baseline was measured from repeated measures mixed effect model with visit, treatment, treatment-by-visit interaction, baseline and the visit-by-baseline interaction as fixed effects.
  • Number of patients with adverse events [ Time Frame: Baseline to 12 months post-dose ]
    Summary statistics on adverse event will be reported. It will be categorized as total adverse events, serious adverse event, death.
  • Change from baseline in Serum amyloid A (SAA) level at 12 months post dose [ Time Frame: Baseline to 12 months post-dose ]
  • Change from baseline in high sensitivity C-reactive protein (hsCRP) at 12 month post-dose [ Time Frame: Baseline to 12 months post-dose ]
Not Provided
Not Provided
 
Safety, Tolerability and Efficacy of ACZ885 on Leg Artery Structure in Patients With Peripheral Artery Disease
A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability and Effects on Arterial Structure and Function of ACZ885 in Patients With Intermittent Claudication.
This study was designed to assess the safety, tolerability and efficacy of ACZ885 on the leg artery structure and physical activity in patients with atherosclerotic peripheral artery disease and leg pain from walking.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Peripheral Artery Disease
  • Drug: Canakinumab (ACZ885)
    Dosage form: solution for injection Strength: 150 mg/1 mL Mode of administration: subcutaneous use.
  • Drug: Placebo
    Matching placebo of Canakinumab
  • Experimental: Canakinumab (ACZ885)
    Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
    Intervention: Drug: Canakinumab (ACZ885)
  • Placebo Comparator: Placebo
    Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
38
August 4, 2016
August 4, 2016   (Final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Must have a signed informed consent form.
  • Must be between the ages of 18 and 85
  • Must experience leg pain associated with walking and have an ankle brachial index between 0.40 and 0.9
  • Must be on stable aspirin and statin doses for at least 6 weeks
  • Blood pressure within ranges specified in the protocol
  • Able to communicate well with the Investigator and understand and comply with the study procedures

Key Exclusion Criteria:

  • Recent use of any other experimental drugs
  • Pregnant or nursing women
  • Women of child bearing potential unless willing to use contraception as detailed in the protocol
  • Cannot walk 15 meters (50 feet)
  • People on restricted medications as listed in the protocol
  • Any open or non-healing wounds with 3 months of study start or infection within 2 weeks or study start
  • Significant heart disease
  • Uncontrolled diabetes
  • Significant kidney or liver disease
  • Live vaccinations within 3 months of study start
  • History of untreated tuberculosis or active tuberculosis (TB)
  • Patients with metal in their body (excluded due to MRI scan) as detailed in the protocol.
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Jordan,   United States
 
 
NCT01731990
CACZ885M2201
2012-001427-12
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
July 2017

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