A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT00265122
First received: December 13, 2005
Last updated: January 20, 2014
Last verified: January 2014
Results First Received: October 23, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Crohn Disease
Interventions: Drug: Ustekinumab 90 mg
Drug: Ustekinumab 4.5 mg/kg
Drug: Placebo SC
Drug: Placebo IV

  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
A total of 131 participants (104 in Population 1 and 27 in Population 2) were enrolled among 42 study centers (35 centers in the US, 6 in Canada, and 1 in Belgium) to receive treatment with placebo or ustekinumab (CNTO 1275) administered subcutaeously (injected under the skin [SC]) or intravenously (infused in a vein [IV]).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with moderate to severe active Crohn’s Disease despite treatment with 5-ASA compounds, antibiotics, corticosteroids, and/or immunomodulators, including anti-TNF agents were enrolled and referred to as Population 1 and those with active disease who failed to respond to infliximab were enrolled and referred to as Population 2.

Reporting Groups
  Description
Population 1: Placebo SC Followed by Ustekinumab SC Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
Population 1: Ustekinumab 90 mg SC Followed by Placebo SC Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
Population 2: Ustekinumab 90 mg SC Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.
Population 2: Ustekinumab 4.5 mg/kg IV Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.

Participant Flow for 2 periods

Period 1:   Intervention Period 1 (Weeks 0 to 8):
    Population 1: Placebo SC Followed by Ustekinumab SC     Population 1: Ustekinumab 90 mg SC Followed by Placebo SC     Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV     Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV     Population 2: Ustekinumab 90 mg SC     Population 2: Ustekinumab 4.5 mg/kg IV  
STARTED     26     25     27     26     14     13  
COMPLETED     24     23     22     24     13     13  
NOT COMPLETED     2     2     5     2     1     0  
Withdrawal by Subject                 1                 1                 3                 0                 1                 0  
Lost to Follow-up                 1                 0                 0                 1                 0                 0  
Not specified                 0                 1                 2                 1                 0                 0  

Period 2:   Intervention Period 2 (Weeks 8 to 28):
    Population 1: Placebo SC Followed by Ustekinumab SC     Population 1: Ustekinumab 90 mg SC Followed by Placebo SC     Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV     Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV     Population 2: Ustekinumab 90 mg SC     Population 2: Ustekinumab 4.5 mg/kg IV  
STARTED     24     23     22     24     13     13  
COMPLETED     17     22     18     20     8     12  
NOT COMPLETED     7     1     4     4     5     1  
Withdrawal by Subject                 2                 1                 3                 1                 3                 0  
Lost to Follow-up                 1                 0                 0                 2                 2                 1  
Not specified                 4                 0                 1                 1                 0                 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
Population 1: Placebo SC Followed by Ustekinumab SC Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
Population 1: Ustekinumab 90 mg SC Followed by Placebo SC Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
Population 2: Ustekinumab 90 mg SC Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.
Population 2: Ustekinumab 4.5 mg/kg IV Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
Total Total of all reporting groups

Baseline Measures
    Population 1: Placebo SC Followed by Ustekinumab SC     Population 1: Ustekinumab 90 mg SC Followed by Placebo SC     Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV     Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV     Population 2: Ustekinumab 90 mg SC     Population 2: Ustekinumab 4.5 mg/kg IV     Total  
Number of Participants  
[units: participants]
  26     25     27     26     14     13     131  
Age  
[units: Years]
Mean ± Standard Deviation
  36.7  ± 13.99     36.5  ± 13.17     43.5  ± 11.39     43.1  ± 12.23     46.9  ± 13.63     42.7  ± 11.27     40.0  ± 12.97  
Gender  
[units: participants]
             
Female     11     10     14     12     6     8     61  
Male     15     15     13     14     8     5     70  



  Outcome Measures
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1.  Primary:   Number of Participants in Population 1 With a Clinical Response at Week 8   [ Time Frame: Week 8 ]

2.  Secondary:   Number of Participants in Population 2 With a Clinical Response at Week 8   [ Time Frame: Week 8 ]

3.  Secondary:   Number of Participants in Population 1 With Clinical Remission at Week 8   [ Time Frame: Week 8 ]


  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
The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in <=5% of patients. This information may vary from existing approved labeling and publications due to the requirement of this website.


  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: Sr. Dir. Clinical Research
Organization: Centocor Research & Development, Inc.
phone: 1-800-457-6399


No publications provided by Centocor, Inc.

Publications automatically indexed to this study:

Responsible Party: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00265122     History of Changes
Other Study ID Numbers: CR005287, C0379T07
Study First Received: December 13, 2005
Results First Received: October 23, 2009
Last Updated: January 20, 2014
Health Authority: United States: Food and Drug Administration