Efficacy, Safety and Tolerability of AIN457 in Moderate to Severe Active Crohn's Disease

This study has been terminated.
(The study was terminated prematurely after futility criterion was met at planned interim analysis of 41 patients.)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00584740
First received: December 21, 2007
Last updated: March 24, 2015
Last verified: March 2015
Results First Received: January 28, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Crohn's Disease
Interventions: Drug: AIN457
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
AIN457 AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
Placebo Matching placebo to AIN457 was given as an infusion at day 1 and day 22.

Participant Flow:   Overall Study
    AIN457     Placebo  
STARTED     39     20  
COMPLETED     27     14  
NOT COMPLETED     12     6  
Adverse Event                 1                 1  
Lack of Efficacy                 8                 2  
Withdrawal by Subject                 3                 2  
Lost to Follow-up                 0                 1  



  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.
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Reporting Groups
  Description
AIN457 AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
Placebo Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
Total Total of all reporting groups

Baseline Measures
    AIN457     Placebo     Total  
Number of Participants  
[units: participants]
  39     20     59  
Age  
[units: Years]
Mean ± Standard Deviation
  37.3  ± 11.96     38.3  ± 14.29     37.6  ± 12.68  
Gender  
[units: Participants]
     
Female     15     9     24  
Male     24     11     35  



  Outcome Measures
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1.  Primary:   Mean Change From Baseline in Crohns Disease Activity Index (CDAI) Score   [ Time Frame: 6 weeks ]

2.  Secondary:   Percentage of Participants Achieving Remission and/or Response   [ Time Frame: 6 weeks ]

3.  Secondary:   Percentage of Participants Achieving Remission   [ Time Frame: 6 weeks ]

4.  Secondary:   Percentage of Participants Achieving Response   [ Time Frame: 6 weeks ]

5.  Secondary:   Mean Change From Baseline in CDAI Score   [ Time Frame: baseline, 2 weeks, 4 weeks ]

6.  Secondary:   Area Under CDAI Curve   [ Time Frame: 10 weeks ]

7.  Secondary:   Percentage of Participants Maintaining Remission   [ Time Frame: 10 weeks ]


  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: Study Director
Organization: Novartis
phone: 862-778-8300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00584740     History of Changes
Other Study ID Numbers: CAIN457A2202
Study First Received: December 21, 2007
Results First Received: January 28, 2015
Last Updated: March 24, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada