An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis

This study has been terminated.
(Protocol was cancelled by company based on overall efficacy, no safety concern)
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00488774
First received: June 18, 2007
Last updated: April 29, 2013
Last verified: April 2013
Results First Received: April 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Colitis, Ulcerative
Interventions: Other: Placebo
Drug: Golimumab 1 mg per kg
Drug: Golimumab 2 mg per kg
Drug: Golimumab 4 mg per 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
Golimumab 1 Milligram (mg) Per Kilogram (kg) Golimumab 1 mg per kg intavenous infusion was administered at Week 0.
Golimumab 2 mg Per kg Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
Golimumab 4 mg Per kg Golimumab 4 mg per kg intavenous infusion was administered at Week 0.

Participant Flow:   Overall Study
    Placebo     Golimumab 1 Milligram (mg) Per Kilogram (kg)     Golimumab 2 mg Per kg     Golimumab 4 mg Per kg  
STARTED     77     62     75     77  
COMPLETED     69     57     70     74  
NOT COMPLETED     8     5     5     3  
Withdrawal of consent                 2                 2                 2                 0  
unspecified                 6                 3                 2                 2  
Lost to Follow-up                 0                 0                 1                 1  



  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 Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
Golimumab 1 mg Per kg Golimumab 1 mg per kg intavenous infusion was administered at Week 0.
Golimumab 2 mg Per kg Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
Golimumab 4 mg Per kg Golimumab 4 mg per kg intavenous infusion was administered at Week 0.
Total Total of all reporting groups

Baseline Measures
    Placebo     Golimumab 1 mg Per kg     Golimumab 2 mg Per kg     Golimumab 4 mg Per kg     Total  
Number of Participants  
[units: participants]
  77     62     75     77     291  
Age  
[units: Years]
Mean ± Standard Deviation
  40.9  ± 12.58     40.7  ± 15.51     42.3  ± 13.14     39.9  ± 14.07     41  ± 13.74  
Gender  
[units: Participants]
         
Female     30     21     39     27     117  
Male     47     41     36     50     174  



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

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


  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
Data collection was not considered complete for primary outcome measure because study was terminated prematurely.


  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: Senior Director
Organization: Janssen Research & Development
phone: 215-793-7540


No publications provided


Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00488774     History of Changes
Obsolete Identifiers: NCT01842152
Other Study ID Numbers: CR014188, C0524T16, 2006-003397-94
Study First Received: June 18, 2007
Results First Received: April 29, 2013
Last Updated: April 29, 2013
Health Authority: United States: Food and Drug Administration