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A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01369342
First received: June 7, 2011
Last updated: November 9, 2016
Last verified: November 2016
Results First Received: September 1, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Crohn's Disease
Inflammatory Bowel Disease
IBD
Colitis
Interventions: Drug: Group 1: Placebo
Drug: Group 2 ustekinumab 130 mg
Drug: Group 3: ustekinumab approximately 6 mg/kg

  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 640 participants were randomly assigned to receive study agent. The analyses (efficacy) were based on the 628 participants who were randomized after the study was restarted. However, one additional participant was excluded from efficacy analyses due to misconduct by the investigative site.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In November 2011, due to stability issue with the batch of the IV drug (130 mg Ustekinumab) sponsor temporarily suspended dosing of participants with ustekinumab. Study was restarted with 90 mg/ml on 17 February 2012.

Reporting Groups
  Description
Placebo IV Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
Ustekinumab 130 Milligram (mg) Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg) Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.

Participant Flow:   Overall Study
    Placebo IV   Ustekinumab 130 Milligram (mg)   Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
STARTED   214   213   213 
COMPLETED   201   204   210 
NOT COMPLETED   13   9   3 
Withdrawal by Subject                7                7                2 
Lost to Follow-up                5                2                1 
Not Treated                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
Placebo IV Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
Ustekinumab 130 Milligram (mg) Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg) Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
Total Total of all reporting groups

Baseline Measures
   Placebo IV   Ustekinumab 130 Milligram (mg)   Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)   Total 
Overall Participants Analyzed 
[Units: Participants]
 214   213   213   640 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.1  (13.09)   39.2  (13.74)   38.8  (13.65)   39.4  (13.48) 
Gender 
[Units: Participants]
Count of Participants
       
Female      113  52.8%      107  50.2%      122  57.3%      342  53.4% 
Male      101  47.2%      106  49.8%      91  42.7%      298  46.6% 
Region of Enrollment 
[Units: Participants]
       
Australia   8   7   5   20 
Belgium   1   1   2   4 
Bulgaria   8   5   11   24 
Brazil   2   5   2   9 
Canada   14   18   10   42 
Germany   19   15   13   47 
Spain   0   1   0   1 
France   3   2   5   10 
United Kingdom   8   8   5   21 
Croatia   1   2   1   4 
Hungary   23   20   18   61 
Iceland   0   1   1   2 
Israel   2   3   6   11 
Italy   2   2   5   9 
Japan   9   8   9   26 
Korea   7   7   6   20 
Netherland   1   1   2   4 
New Zealand   2   8   4   14 
Poland   8   8   10   26 
Russia   6   6   5   17 
Serbia   4   8   3   15 
United States   72   72   76   220 
South Africa   14   5   14   33 


  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Number of Participants in Clinical Remission at Week 8   [ Time Frame: Week 8 ]

3.  Secondary:   Number of Participants in Clinical Response at Week 8   [ Time Frame: Week 8 ]

4.  Secondary:   Number of Participants With Crohn's Disease Activity Index (CDAI) 70 Point Response at Week 6   [ Time Frame: Week 6 ]

5.  Secondary:   Number of Participants With CDAI 70 Point Response at Week 3   [ Time Frame: Week 3 ]


  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 global study was interrupted due to issues with the clinical supply.


  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: Vice President
Organization: Janssen Research & Development, LLC
e-mail: ClinicalTrialDisclosure@its.jnj.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01369342     History of Changes
Other Study ID Numbers: CR018418
CNTO1275CRD3002 ( Other Identifier: Janssen Research & Development, LLC )
2010-022759-42 ( EudraCT Number )
Study First Received: June 7, 2011
Results First Received: September 1, 2016
Last Updated: November 9, 2016