An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00488631
First received: June 18, 2007
Last updated: March 27, 2014
Last verified: March 2014
Results First Received: May 1, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Colitis, Ulcerative
Interventions: Biological: Placebo
Biological: Golimumab 50 mg
Biological: Golimumab 100 mg
Biological: Golimumab 200 mg

  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
Efficacy results are based on participants who were Golimumab induction responders (GLM-I-Rsp) and were randomly assigned to GLM-I-Rsp-Placebo Maintenance, GLM-I-Rsp-Golimumab 50 mg and GLM-I-Rsp-Golimumab 100 mg as per planned analysis.

Reporting Groups
  Description
Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
GLM-I-Rsp-Golimumab 50 mg Maintenance Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injections every 4 weeks through Week 52.
GLM-I-Rsp-Golimumab 100 mg Maintenance Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injections every 4 weeks through Week 52 (prior to protocol amendment 3).
Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance Participants in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
PBO-I-nonRsp-Golimumab 100 mg Maintenance Participants not in clinical response to placebo at Week 6 induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
GLM-I-nonRsp-Golimumab 100 mg Maintenance Participants not in clinical response to golimumab at Week 6 of induction study and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.

Participant Flow:   Overall Study
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance     GLM-I-Rsp-Golimumab 50 mg Maintenance     GLM-I-Rsp-Golimumab 100 mg Maintenance     Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance     PBO-I-nonRsp-Golimumab 100 mg Maintenance     GLM-I-nonRsp-Golimumab 100 mg Maintenance  
STARTED     156     154     154     129     230     405  
COMPLETED     113     111     109     88     127     189  
NOT COMPLETED     43     43     45     41     103     216  
Adverse Event                 17                 12                 12                 12                 30                 50  
Death                 0                 0                 0                 0                 0                 1  
Unsatisfactory therapeutic effect                 19                 17                 22                 18                 56                 124  
Lost to Follow-up                 1                 2                 1                 0                 3                 7  
Unspecified                 6                 12                 10                 11                 14                 34  



  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.
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Reporting Groups
  Description
Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
GLM-I-Rsp-Golimumab 50 mg Maintenance Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injections every 4 weeks through Week 52.
GLM-I-Rsp-Golimumab 100 mg Maintenance Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injections every 4 weeks through Week 52 (prior to protocol amendment 3).
Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance Participants in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
PBO-I-nonRsp-Golimumab 100 mg Maintenance Participants not in clinical response to placebo at Week 6 induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
GLM-I-nonRsp-Golimumab 100 mg Maintenance Participants not in clinical response to golimumab at Week 6 of induction study and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
Total Total of all reporting groups

Baseline Measures
    Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance     GLM-I-Rsp-Golimumab 50 mg Maintenance     GLM-I-Rsp-Golimumab 100 mg Maintenance     Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance     PBO-I-nonRsp-Golimumab 100 mg Maintenance     GLM-I-nonRsp-Golimumab 100 mg Maintenance     Total  
Number of Participants  
[units: participants]
  156     154     154     129     230     405     1228  
Age  
[units: years]
Mean ± Standard Deviation
  40.2  ± 14.05     41.4  ± 13.84     39.1  ± 13.11     38  ± 13.27     40.3  ± 12.67     41.2  ± 13.6     40.3  ± 13.44  
Gender  
[units: participants]
             
Female     81     77     65     68     99     138     528  
Male     75     77     89     61     131     267     700  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants in Clinical Response Through Week 54   [ Time Frame: Induction Baseline, Week 0 through Week 54 ]

2.  Secondary:   Number of Participants With Clinical Remission at Both Week 30 and Week 54   [ Time Frame: Week 30 and Week 54 ]

3.  Secondary:   Number of Participants With Mucosal Healing at Both Week 30 and Week 54   [ Time Frame: Week 30 and Week 54 ]

4.  Secondary:   Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study   [ Time Frame: Week 30 and Week 54 ]

5.  Secondary:   Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study   [ Time Frame: Week 54 ]


  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
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  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 by Janssen Research & Development, LLC

Publications automatically indexed to this study:

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00488631     History of Changes
Other Study ID Numbers: CR014179, 2006-003399-37, C0524T18
Study First Received: June 18, 2007
Results First Received: May 1, 2013
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration