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Safety and Efficacy of Multiple Doses of Canakinumab (ACZ885) in Chronic Obstructive Pulmonary Disease (COPD) Patients

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00581945
First received: December 21, 2007
Last updated: June 28, 2011
Last verified: June 2011
Results First Received: May 26, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Basic Science
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: Canakinumab
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Canakinumab Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
Placebo Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.

Participant Flow:   Overall Study
    Canakinumab     Placebo  
STARTED     74     73  
COMPLETED     65     63  
NOT COMPLETED     9     10  
Adverse Event                 4                 4  
Unsatisfactory therapeutic effect                 2                 0  
Withdrawal by Subject                 2                 6  
Death                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Canakinumab Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
Placebo Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
Total Total of all reporting groups

Baseline Measures
    Canakinumab     Placebo     Total  
Number of Participants  
[units: participants]
  74     73     147  
Age  
[units: years]
Mean ± Standard Deviation
  63.9  ± 7.70     63.6  ± 7.92     63.7  ± 7.78  
Gender  
[units: participants]
     
Female     28     31     59  
Male     46     42     88  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: Baseline, Week 25 and Week 45 ]

2.  Primary:   Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted   [ Time Frame: Baseline, Week 25 and Week 45 ]

3.  Primary:   Change From Baseline in Forced Vital Capacity (FVC)   [ Time Frame: Baseline, Week 25 and Week 45 ]

4.  Primary:   Change From Baseline in Slow Vital Capacity (SVC)   [ Time Frame: Baseline, Week 25 and Week 45 ]

5.  Primary:   Change From Baseline in Forced Expiratory Flow 25% to 75%   [ Time Frame: Baseline, Week 25 and Week 45 ]

6.  Secondary:   Number of Participants Who Experienced Serious Adverse Events or Discontinued Due to Adverse Events   [ Time Frame: Adverse events were collected during the 45 week treatment period and the 12 week follow-up period. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Novartis Pharmaceuticals
Organization: Study Director
phone: 862-778-8300


No publications provided


Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00581945     History of Changes
Other Study ID Numbers: CACZ885B2204
Study First Received: December 21, 2007
Results First Received: May 26, 2011
Last Updated: June 28, 2011
Health Authority: United States: Food and Drug Administration