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A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)

This study has been terminated.
(Trial has failed to meet primary - and major secondary endpoints)
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01230827
First received: October 28, 2010
Last updated: March 31, 2016
Last verified: March 2016
Results First Received: September 23, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Juvenile Idiopathic Arthritis
Interventions: Drug: CNTO 148 (Golimumab)
Drug: Placebo
Drug: Methotrexate

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Group I: Participants Who Did Not Enter RW Period Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology [ACR] Ped 30 response) at Week 16.
Group II: Placebo Subcutaneously (SC) + MTX Participants who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48.
Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX Participants who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48.
Group IV: Golimumab + MTX Participants were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX through Week 48.

Participant Flow:   Overall Study
    Group I: Participants Who Did Not Enter RW Period   Group II: Placebo Subcutaneously (SC) + MTX   Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX   Group IV: Golimumab + MTX
STARTED   19   11   65   78 
COMPLETED   0   0   0   0 
NOT COMPLETED   19   11   65   78 
Lost to Follow-up                0                0                1                3 
Withdrawal by Subject                1                0                3                2 
Lack of Efficacy                14                1                2                3 
Adverse Event                4                2                3                7 
Recovery                0                6                0                0 
Study terminated by Sponsor                0                2                56                63 



  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
Group I: Participants Who Did Not Enter RW Period Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology [ACR] Ped 30 response) at Week 16.
Group II: Placebo Subcutaneously (SC) + MTX Participants who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48.
Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX Participants who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48.
Group IV: Golimumab + MTX Participants were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX through Week 48.
Total Total of all reporting groups

Baseline Measures
   Group I: Participants Who Did Not Enter RW Period   Group II: Placebo Subcutaneously (SC) + MTX   Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX   Group IV: Golimumab + MTX   Total 
Overall Participants Analyzed 
[Units: Participants]
 19   11   65   78   173 
Age 
[Units: Years]
Mean (Standard Deviation)
 11.8  (4.4)   13.6  (2.2)   10.7  (4.66)   11.1  (4.43)   11.2  (4.44) 
Gender 
[Units: Participants]
         
Female   15   6   51   59   131 
Male   4   5   14   19   42 
Region of Enrollment 
[Units: Participants]
         
Austria   1   0   2   2   5 
Belgium   2   1   5   2   10 
Brazil   1   0   3   4   8 
Canada   2   0   0   5   7 
Finland   0   0   0   1   1 
Germany   4   7   14   24   49 
Lithuania   0   0   6   4   10 
Mexico   2   1   8   11   22 
Netherlands   0   0   2   2   4 
Poland   2   0   1   4   7 
Russian Federation   4   1   12   12   29 
United States   1   1   12   7   21 


  Outcome Measures
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1.  Primary:   Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 16 Who Did Not Experienced a Flare of Disease Through Week 48   [ Time Frame: Week 16 through Week 48 ]

2.  Secondary:   Percentage of Participants With American College of Rheumatology (ACR) 30 Response at Week 48   [ Time Frame: Week 16 through Week 48 ]

3.  Secondary:   Percentage of Participants With American College of Rheumatology (ACR) 30 Response Who Had Inactive Disease at Week 48   [ Time Frame: Week 16 through Week 48 ]

4.  Secondary:   Percentage of Participants Who Achieved Clinical Remission While on Medication for Juvenile Idiopathic Arthritis (JIA) at Week 48   [ Time Frame: Week 16 through Week 48 ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Senior Director Clinical Research
Organization: Johnson & Johnson Pharmaceutical Research & Development
e-mail: ClinicalTrialDisclosure@its.jnj.com



Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01230827     History of Changes
Obsolete Identifiers: NCT01777399
Other Study ID Numbers: CR017089
CNTO148JIA3001 ( Other Identifier: Janssen Research & Development, LLC )
2009-015019-42 ( EudraCT Number )
Study First Received: October 28, 2010
Results First Received: September 23, 2014
Last Updated: March 31, 2016
Health Authority: United States: Food and Drug Administration