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: September 23, 2014
Last verified: September 2014
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
173 enrolled participants received Golimumab SC injection at a dose of 30 mg/m^2 every 4 weeks for 12 weeks. Methotrexate was continued weekly at the same dose as at the time of study entry. At Week 16, ACR Ped 30 responders were randomly assigned to Group II: Placebo + Methotrexate and Group III: Golimumab + Methotrexate.

Reporting Groups
  Description
Group I: Enrolled 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] Pediatric [Ped] 30 response) at Week 16.
Group II: Placebo + Methotrexate Participants randomized to Placebo group received placebo as a subcutaneous (SC), injection at Week 16 and every 4 weeks until Week 48 unless participants experienced a flare of disease at which time golimumab 30 milligram per meter square (mg/m^2) SC injections (maximum 50 mg) were resumed. Methotrexate was continued weekly at the same dose as at the time of study entry.
Group III: Golimumab + Methotrexate Participants, randomized to Golimumab received golimumab 30 mg/m^2 SC injection (maximum 50 mg) at Week 16, and every 4 weeks thereafter through Week 48. Methotrexate was continued weekly at the same dose as at the time of study entry.

Participant Flow:   Overall Study
    Group I: Enrolled Participants Who Did Not Enter RW Period     Group II: Placebo + Methotrexate     Group III: Golimumab + Methotrexate  
STARTED     19     76     78  
COMPLETED     0     72     72  
NOT COMPLETED     19     4     6  
Adverse Event                 4                 3                 2  
Lack of Efficacy                 14                 1                 1  
Withdrawal by Subject                 1                 0                 2  
Lost to Follow-up                 0                 0                 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.
The Baseline Analysis Population included all the enrolled participants.

Reporting Groups
  Description
Group I: Enrolled 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] Pediatric [Ped] 30 response) at Week 16.
Group II: Placebo + Methotrexate Participants randomized to Placebo group received placebo as a subcutaneous (SC), injection at Week 16 and every 4 weeks until Week 48 unless participants experienced a flare of disease at which time golimumab 30 milligram per meter square (mg/m^2) SC injections (maximum 50 mg) were resumed. Methotrexate was continued weekly at the same dose as at the time of study entry.
Group III: Golimumab + Methotrexate Participants, randomized to Golimumab received golimumab 30 mg/m^2 SC injection (maximum 50 mg) at Week 16, and every 4 weeks thereafter through Week 48. Methotrexate was continued weekly at the same dose as at the time of study entry.
Total Total of all reporting groups

Baseline Measures
    Group I: Enrolled Participants Who Did Not Enter RW Period     Group II: Placebo + Methotrexate     Group III: Golimumab + Methotrexate     Total  
Number of Participants  
[units: participants]
  19     76     78     173  
Age  
[units: years]
Mean ± Standard Deviation
  11.8  ± 4.4     11.1  ± 4.51     11.1  ± 4.43     11.2  ± 4.44  
Gender  
[units: participants]
       
Female     15     57     59     131  
Male     4     19     19     42  
Region of Enrollment  
[units: participants]
       
Austria     1     2     2     5  
Belgium     2     6     2     10  
Brazil     1     3     4     8  
Canada     2     0     5     7  
Finland     0     0     1     1  
Germany     4     21     24     49  
Lithuania     0     6     4     10  
Mexico     2     9     11     22  
Netherlands     0     2     2     4  
Poland     2     1     4     7  
Russian Federation     4     13     12     29  
United States     1     13     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 Experienced a Flare of Disease   [ 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


No publications provided


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