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A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)

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ClinicalTrials.gov Identifier: NCT01369329
Recruitment Status : Completed
First Posted : June 8, 2011
Results First Posted : December 7, 2016
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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
IBD
Colitis
Inflammatory Bowel Disease
Interventions: Drug: Group 2 ustekinumab 130 mg
Drug: Group 3: ustekinumab approximately 6 mg/kg
Drug: Group 1: Placebo

  Participant Flow

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 769 participants were randomly assigned to receive study agent. The analyses (efficacy) was based on the 741 participants who were randomized after the study was restarted.

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 intravenous (IV) drug (130 mg Ustekinumab) sponsor temporarily suspended dosing of participants with ustekinumab. Later study was restarted with 90 milligram per milliliter (mg/ml).

Reporting Groups
  Description
Placebo 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   Ustekinumab 130 Milligram (mg)   Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)
STARTED   256   254   259 
COMPLETED   244   243   245 
NOT COMPLETED   12   11   14 
Withdrawal by Subject                8                6                10 
Lost to Follow-up                2                2                2 
Other                2                3                2 



  Baseline Characteristics

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 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   Ustekinumab 130 Milligram (mg)   Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 256   254   259   769 
Age 
[Units: Years]
Mean (Standard Deviation) 		 37.6  (11.86)   37.4  (11.74)   37.2  (12.57)   37.4  (12.05) 
Gender 
[Units: Participants]
 		       
Female   135   153   152   440 
Male   121   101   107   329 
Region of Enrollment 
[Units: Participants]
 		       
Australia   6   7   8   21 
Austria   0   0   6   6 
Belgium   8   12   8   28 
Brazil   2   0   1   3 
Canada   10   21   21   52 
Czech Republic   2   2   1   5 
Germany   22   14   14   50 
Denmark   1   3   2   6 
Spain   0   0   2   2 
France   17   21   29   67 
United Kingdom   21   21   16   58 
Hungary   1   1   2   4 
Ireland   0   0   1   1 
Israel   1   2   3   6 
Italy   4   7   8   19 
Japan   18   19   19   56 
South Korea   1   0   2   3 
Netherlands   9   9   14   32 
New Zealand   1   1   0   2 
Poland   4   3   4   11 
Serbia   1   2   1   4 
United States   126   108   97   331 
South Africa   1   1   0   2 


  Outcome Measures

1.  Primary:   Number of Participants With Clinical Response at Week 6   [ Time Frame: Baseline and Week 6 ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants in Clinical Remission at Week 8   [ Time Frame: Baseline and Week 8 ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants in Clinical Response at Week 8   [ Time Frame: Baseline and Week 8 ]
  Show Outcome Measure 3

4.  Secondary:   Number of Participants With Crohn's Disease Activity Index (CDAI) 70-point Response at Week 6   [ Time Frame: Baseline and Week 6 ]
  Show Outcome Measure 4

5.  Secondary:   Number of Participants With CDAI 70-point Response at Week 3   [ Time Frame: Baseline and Week 3 ]
  Show Outcome Measure 5


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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: NCT01369329     History of Changes
Other Study ID Numbers: CR018415
CNTO1275CRD3001 ( Other Identifier: Janssen Research & Development, LLC )
2010-022758-18 ( EudraCT Number )
First Submitted: June 7, 2011
First Posted: June 8, 2011
Results First Submitted: August 1, 2016
Results First Posted: December 7, 2016
Last Update Posted: December 7, 2016