We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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: August 22, 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 )
  Purpose
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.

Condition Intervention Phase
Peripheral Artery Disease Drug: Canakinumab (ACZ885) Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 38
Actual Study Start Date: October 30, 2012
Study Completion Date: August 4, 2016
Primary Completion Date: August 4, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Canakinumab (ACZ885)
Monthly subcutaneous doses of Canakinumab 150 mg/1 mL for 12 months
Drug: Canakinumab (ACZ885)
Dosage form: solution for injection Strength: 150 mg/1 mL Mode of administration: subcutaneous use.
Placebo Comparator: Placebo
Monthly subcutaneous doses of placebo of Canakinumab 150 mg/1 mL for 12 months
Drug: Placebo
Matching placebo of Canakinumab

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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): NCT01731990


Locations
United States, Arizona
Novartis Investigative Site
Phoenix, Arizona, United States, 85302
United States, Florida
Novartis Investigative Site
Jacksonville, Florida, United States, 32207
Novartis Investigative Site
Jacksonville, Florida, United States, 32216
United States, Illinois
Novartis Investigative Site
Chicago, Illinois, United States, 60611
United States, Maryland
Novartis Investigative Site
Lutherville, Maryland, United States, 21093
United States, Ohio
Novartis Investigative Site
Columbus, Ohio, United States, 43215
United States, Tennessee
Novartis Investigative Site
Knoxville, Tennessee, United States, 37920
United States, Virginia
Novartis Investigative Site
Richmond, Virginia, United States, 23294
Germany
Novartis Investigative Site
Hamburg, Germany, 20099
Novartis Investigative Site
Hamburg, Germany, 22559
Novartis Investigative Site
Heidelberg, Germany, 69120
Novartis Investigative Site
Mainz, Germany, 55116
Novartis Investigative Site
München, Germany, 80336
Jordan
Novartis Investigative Site
Amman, Jordan, 11941
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01731990     History of Changes
Other Study ID Numbers: CACZ885M2201
2012-001427-12
First Submitted: November 18, 2012
First Posted: November 22, 2012
Results First Submitted: July 21, 2017
Results First Posted: August 22, 2017
Last Update Posted: August 22, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Peripheral artery disease
Intermittent claudication
magnetic resonance imaging

Additional relevant MeSH terms:
Peripheral Arterial Disease
Intermittent Claudication
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Signs and Symptoms
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs


To Top