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

This study has been completed.
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 24, 2016
Last verified: March 2016
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 injection matching to golimumab administered every 4 weeks through Week 52 in the 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. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
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 C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
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 injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab 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. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
PBO-I-nonRsp-Golimumab 100 mg Maintenance Participants not in clinical response to placebo at Week 6 of 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 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.
Placebo Extension Participants entered the study extension at Week 54 receiving placebo subcutaneous injection administered every 4 weeks until study unblinding and discontinuation of participants remaining on placebo; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks in the study extension.
Golimumab 50 mg - Extension Participants entered the study extension at Week 54 receiving golimumab 50 mg subcutaneous injection administered every 4 weeks; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks.
Golimumab 100 mg Extension Participants entered the study extension at Week 54 receiving golimumab 100 mg subcutaneous injection administered every 4 weeks; prior to Amendment 3 , those whose UC disease worsened had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks.
Golimumab 200 mg Extension Participants entered the study extension at Week 54 receiving golimumab 200 mg subcutaneous injection administered every 4 weeks. With Amendment 3 participants remaining on golimumab 200 mg had their dose decreased to golimumab 100 mg subcutaneous injection administered every 4 weeks.

Participant Flow for 2 periods

Period 1:   Double Blind Period (Week 0-54)
    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   Placebo Extension   Golimumab 50 mg - Extension   Golimumab 100 mg Extension   Golimumab 200 mg Extension
STARTED   156   154   154   129   230   405   0   0   0   0 
COMPLETED   113   111   109   88   127   189   0   0   0   0 
NOT COMPLETED   43   43   45   41   103   216   0   0   0   0 
Adverse Event                17                12                12                12                30                50                0                0                0                0 
Death                0                0                0                0                0                1                0                0                0                0 
Unsatisfactory therapeutic effect                19                17                22                18                56                124                0                0                0                0 
Lost to Follow-up                1                2                1                0                3                7                0                0                0                0 
Unspecified                6                12                10                11                14                34                0                0                0                0 

Period 2:   Open Label Study Extension (Week 54-228)
    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   Placebo Extension   Golimumab 50 mg - Extension   Golimumab 100 mg Extension   Golimumab 200 mg Extension
STARTED   0   0   0   0   0   0   96   93   470   7 
COMPLETED   0   0   0   0   0   0   16   66   288   4 
NOT COMPLETED   0   0   0   0   0   0   80   27   182   3 
Adverse Event                0                0                0                0                0                0                10                8                54                0 
Death                0                0                0                0                0                0                0                0                1                0 
Unsatisfactory therapeutic effect                0                0                0                0                0                0                5                5                34                3 
Lost to Follow-up                0                0                0                0                0                0                2                0                6                0 
Unspecified reasons                0                0                0                0                0                0                63                14                87                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
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 injection matching to golimumab administered every 4 weeks through Week 52 in the 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. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
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 C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
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 injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab 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. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
PBO-I-nonRsp-Golimumab 100 mg Maintenance Participants not in clinical response to placebo at Week 6 of 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 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.
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 
Overall Participants Analyzed 
[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


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

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00488631     History of Changes
Other Study ID Numbers: CR014179
2006-003399-37 ( EudraCT Number )
C0524T18 ( Other Identifier: Janssen Research & Development, LLC )
Study First Received: June 18, 2007
Results First Received: May 1, 2013
Last Updated: March 24, 2016
Health Authority: United States: Food and Drug Administration