A Study of Safety and Effectiveness of Ustekinumab in Patients With Moderate to Severe Active Crohn's Disease Who Have Been Previously Treated With Anti-TNF Therapy

This study has been completed.
Sponsor:
Information provided by:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00771667
First received: October 10, 2008
Last updated: March 26, 2013
Last verified: March 2013
Results First Received: October 10, 2011  
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: Placebo (IP)
Drug: Ustekinumab 1mg/kg (IP)
Drug: Ustekinumab 3 mg/kg (IP)
Drug: Ustekinumab 6 mg/kg (IP)
Drug: Placebo IV - Responder - Placebo SC (MP)
Drug: Placebo IV - Nonresponder - Ustekinumab 270/90 mg SC (MP)
Drug: Ustekinumab IV - Responder - Placebo SC (MP)
Drug: Ustekinumab IV - Responder - Ustekinumab 90mg SC (MP)
Drug: Ustekinumab IV - Nonresponder - Placebo SC (MP)
Drug: Ustekinumab IV - Nonresponder - Ustekinumab 90mg SC (MP)

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo (IP) Induction phase (Week 0-8) (IP) - Placebo IV group
Ustekinumab 1 mg/kg (IP) Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
Ustekinumab 3 mg/kg (IP) Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
Ustekinumab 6 mg/kg (IP) Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
Placebo IV -> Responder -> Placebo SC (MP) Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -> Responder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP) Maintenance phase (Week 8-36) (MP) - Receiving Placebo IV at Week 0 -> Nonresponder at week 6 -> Receiving Ustekinumab 270 mg SC at Week 8 and 90 mg at Week 16
Ustekinumab IV -> Responder -> Placebo SC (MP) Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Responder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP) Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Responder at week 6 -> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16
Ustekinumab IV -> Nonresponder -> Placebo SC (MP) Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Nonresponder at week 6 -> Receiving Placebo SC at Week 8 and Week 16
Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP) Maintenance phase (Week 8-36) (MP) - Receiving Ustekinumab IV at Week 0 -> Nonresponder at week 6 -> Receiving Ustekinumab 90 mg SC at Week 8 and Week 16

Participant Flow for 2 periods

Period 1:   Induction Phase
    Placebo (IP)     Ustekinumab 1 mg/kg (IP)     Ustekinumab 3 mg/kg (IP)     Ustekinumab 6 mg/kg (IP)     Placebo IV -> Responder -> Placebo SC (MP)     Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP)     Ustekinumab IV -> Responder -> Placebo SC (MP)     Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP)     Ustekinumab IV -> Nonresponder -> Placebo SC (MP)     Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP)  
STARTED     132     131     132     131     0 [1]   0 [1]   0 [1]   0 [1]   0 [1]   0 [1]
COMPLETED     113     121     120     123     0     0     0     0     0     0  
NOT COMPLETED     19     10     12     8     0     0     0     0     0     0  
Adverse Event                 5                 2                 4                 1                 0                 0                 0                 0                 0                 0  
Lack of Efficacy                 9                 2                 4                 3                 0                 0                 0                 0                 0                 0  
Lost to Follow-up                 1                 0                 1                 0                 0                 0                 0                 0                 0                 0  
Other                 4                 6                 3                 4                 0                 0                 0                 0                 0                 0  
[1] "0" in column indicates this reporting group is not relevant to Induction period.

Period 2:   Maintenance Phase
    Placebo (IP)     Ustekinumab 1 mg/kg (IP)     Ustekinumab 3 mg/kg (IP)     Ustekinumab 6 mg/kg (IP)     Placebo IV -> Responder -> Placebo SC (MP)     Placebo IV -> Nonresponder -> Ustekinumab 270/90 mg SC (MP)     Ustekinumab IV -> Responder -> Placebo SC (MP)     Ustekinumab IV -> Responder -> Ustekinumab 90mg SC (MP)     Ustekinumab IV -> Nonresponder -> Placebo SC (MP)     Ustekinumab IV -> Nonresponder -> Ustekinumab 90mg SC (MP)  
STARTED     0 [1]   0 [1]   0 [1]   0 [1]   28     85     73     72     110     109  
COMPLETED     0     0     0     0     26     78     63     67     88     92  
NOT COMPLETED     0     0     0     0     2     7     10     5     22     17  
Adverse Event                 0                 0                 0                 0                 1                 3                 5                 1                 8                 7  
Lack of Efficacy                 0                 0                 0                 0                 1                 3                 3                 2                 11                 7  
Other                 0                 0                 0                 0                 0                 1                 2                 2                 3                 3  
[1] "0" in column indicates this reporting group is not relevant to Maintenance period.



  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
Placebo (IP) Induction phase (Week 0-8) (IP) - Placebo IV group
Ustekinumab 1 mg/kg (IP) Induction phase (Week 0-8) (IP) - Ustekinumab 1mg/kg IV group
Ustekinumab 3 mg/kg (IP) Induction phase (Week 0-8) (IP) - Ustekinumab 3mg/kg IV group
Ustekinumab 6 mg/kg (IP) Induction phase (Week 0-8) (IP) - Ustekinumab 6mg/kg IV group
Total Total of all reporting groups

Baseline Measures
    Placebo (IP)     Ustekinumab 1 mg/kg (IP)     Ustekinumab 3 mg/kg (IP)     Ustekinumab 6 mg/kg (IP)     Total  
Number of Participants  
[units: participants]
  132     131     132     131     526  
Age  
[units: years]
Mean ± Standard Deviation
  39.5  ± 13.05     38.8  ± 11.95     38.2  ± 12.63     39.4  ± 13.21     39  ± 12.69  
Gender  
[units: participants]
         
Female     68     83     75     83     309  
Male     64     48     57     48     217  



  Outcome Measures
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1.  Primary:   Number of Participants With Clinical Response at Week 6   [ Time Frame: Baseline to Week 6 ]

2.  Secondary:   Number of Participants With Clinical Remission at Week 6   [ Time Frame: Baseline to Week 6 ]

3.  Secondary:   Number of Participants With Clinical Response at Week 4   [ Time Frame: Baseline to Week 4 ]

4.  Secondary:   Number of Participants With Clinical Response at Week 8   [ Time Frame: Baseline to Week 8 ]

5.  Secondary:   Number of Participants With Clinical Remission at Week 8   [ Time Frame: Baseline to Week 8 ]

6.  Secondary:   Number of Participants With Clinical Remission at Week 22 (Among Responders From Week 6)   [ Time Frame: Baseline to Week 22 ]

7.  Secondary:   Number of Participants With Clinical Response at Week 22 (Among Responders From Week 6)   [ Time Frame: Baseline to Week 22 ]


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Director, Clinical Research
Organization: Janssen Research and Development, US
phone: 610-651-6554


No publications provided by Centocor, Inc.

Publications automatically indexed to this study:

Responsible Party: Director, Clinical Research, Janssen R&D US
ClinicalTrials.gov Identifier: NCT00771667     History of Changes
Other Study ID Numbers: CR015238, C0743T26
Study First Received: October 10, 2008
Results First Received: October 10, 2011
Last Updated: March 26, 2013
Health Authority: United States: Food and Drug Administration