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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01369355
First Posted: June 8, 2011
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Janssen Research & Development, LLC
Results First Submitted: October 17, 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
Colitis
IBD
Inflammatory Bowel Disease
Interventions: Drug: Placebo SC
Drug: Placebo IV
Drug: Ustekinumab 90 mg SC q8w
Drug: Ustekinumab 130 mg IV
Drug: Ustekinumab 90 mg SC q12w

  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
Out of 1282 participants enrolled,1 was excluded from study before assignment to arm/group due to deviation from Good Clinical Practice at 1 study site. Hence 1281 participants were analyzed. Total 397 participants who were in clinical response to ustekinumab induction were randomized in maintenance study and considered as primary population.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Due to a stability issue with the batch of Intravenous (IV) drug (130 mg Ustekinumab), in November 2011 sponsor temporarily suspended dosing in induction studies (CRD3001 and CRD3002) and this maintenance study (CRD3003). All 3 studies were restarted with a 90 milligram per millilter (mg/mL) formulation for IV administration on 17 February 2012.

Reporting Groups
  Description
Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 milligrams (mg) q12w in the maintenance study.
UST-I-Rsp-UST-90 mg Q8W Maintenance Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.
Placebo (PBO)-I-Rsp - PBO Maintenance Participants (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC q4w in the maintenance study.
PBO-I-nonRsp - UST-130mg Intravenous/90mg SC Q12W Maintenance Participants (who were not in clinical response to placebo IV at Week 8 of an induction study) received Ustekinumab 130 mg IV on entry into maintenance followed by Ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response).
UST-I-nonRsp - UST-90mg Subcutaneously (SC) Q8W Maintenance Participants (who were not in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab 90 mg SC on entry into maintenance followed by Ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response).

Participant Flow:   Overall Study
    Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance   UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance   UST-I-Rsp-UST-90 mg Q8W Maintenance   Placebo (PBO)-I-Rsp - PBO Maintenance   PBO-I-nonRsp - UST-130mg Intravenous/90mg SC Q12W Maintenance   UST-I-nonRsp - UST-90mg Subcutaneously (SC) Q8W Maintenance
STARTED   133   132   132   123   285   476 
Treated   133   132   131   123   285   476 
COMPLETED   102   103   101   93   131   204 
NOT COMPLETED   31   29   31   30   154   272 
Adverse Event                9                12                6                7                14                25 
Lack of Efficacy                15                14                15                15                126                217 
Protocol Violation                0                1                1                0                0                2 
Lost to Follow-up                1                0                1                2                5                6 
Withdrawal by Subject                6                2                7                6                8                22 
Other                0                0                0                0                1                0 
Not Treated                0                0                1                0                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
Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 milligrams (mg) q12w in the maintenance study.
UST-I-Rsp-UST-90 mg Q8W Maintenance Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.
Placebo (PBO)-I-Rsp - PBO Maintenance Participants (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC q4w in the maintenance study.
PBO-I-nonRsp - UST-130mg Intravenous/90mg SC Q12W Maintenance Participants (who were not in clinical response to placebo IV at Week 8 of an induction study) received Ustekinumab 130 mg IV on entry into maintenance followed by Ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response).
UST-I-nonRsp - UST-90mg Subcutaneously (SC) Q8W Maintenance Participants (who were not in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab 90 mg SC on entry into maintenance followed by Ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response).
Total Total of all reporting groups

Baseline Measures
   Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance   UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance   UST-I-Rsp-UST-90 mg Q8W Maintenance   Placebo (PBO)-I-Rsp - PBO Maintenance   PBO-I-nonRsp - UST-130mg Intravenous/90mg SC Q12W Maintenance   UST-I-nonRsp - UST-90mg Subcutaneously (SC) Q8W Maintenance   Total 
Overall Participants Analyzed 
[Units: Participants]
 133   132   132   123   285   476   1281 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.5  (12.69)   38.6  (13.65)   37.9  (13.2)   39.1  (12.46)   39  (12.33)   37.4  (12.5)   38.3  (12.68) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
             
Female      74  55.6%      74  56.1%      76  57.6%      64  52.0%      149  52.3%      275  57.8%      712  55.6% 
Male      59  44.4%      58  43.9%      56  42.4%      59  48.0%      136  47.7%      201  42.2%      569  44.4% 
Region of Enrollment 
[Units: Participants]
             
Australia   4   2   3   4   10   15   38 
Austria   1   3   1   0   0   1   6 
Belgium   2   4   1   1   7   16   31 
Bulgaria   5   2   2   4   1   7   21 
Brazil   1   1   3   2   2   3   12 
Canada   10   4   12   5   17   44   92 
Czech Republic   0   0   1   0   2   2   5 
Germany   9   8   7   7   27   26   84 
Denmark   1   2   1   0   0   0   4 
Spain   1   0   1   0   0   1   3 
France   6   8   9   1   13   27   64 
United Kingdom   4   7   5   7   15   29   67 
Croatia   1   1   0   1   0   1   4 
Hungary   11   8   8   10   14   13   64 
Ireland   0   0   1   0   0   0   1 
Iceland   1   1   0   0   0   0   2 
Israel   3   1   0   1   2   8   15 
Italy   6   2   2   1   4   8   23 
Japan   4   8   9   4   18   31   74 
South Korea   3   3   2   2   5   7   22 
Netherlands   4   4   4   1   9   14   36 
New Zealand   3   5   2   1   1   3   15 
Poland   3   5   6   6   6   10   36 
Russia   2   2   3   5   1   4   17 
Serbia   2   7   4   3   2   1   19 
United States of America   41   42   40   50   124   198   495 
South Africa   5   2   5   7   5   7   31 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Clinical Remission at Week 44   [ Time Frame: Week 44 ]

2.  Secondary:   Number of Participants With Clinical Response at Week 44   [ Time Frame: Week 44 ]

3.  Secondary:   Number of Participants in Clinical Remission at Week 44 Among Participants in Clinical Remission to Ustekinumab at Week 0 of Maintenance Study   [ Time Frame: Week 44 ]

4.  Secondary:   Number of Participants With Corticosteroid-free Remission at Week 44   [ Time Frame: Week 44 ]

5.  Secondary:   Number of Participants in Clinical Remission at Week 44 in the Subset of Participants Who Were Refractory or Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy   [ Time Frame: Week 44 ]


  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: NCT01369355     History of Changes
Other Study ID Numbers: CR018421
CNTO1275CRD3003 ( Other Identifier: Janssen Research & Development, LLC )
2010-022760-12 ( EudraCT Number )
First Submitted: June 7, 2011
First Posted: June 8, 2011
Results First Submitted: October 17, 2016
Results First Posted: February 23, 2017
Last Update Posted: November 6, 2017