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Single Patient Use of Tocilizumab in Systemic Onset Juvenile Idiopathic Arthritis

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ClinicalTrials.gov Identifier: NCT00868751
Recruitment Status : Terminated (Hyperintensities of unclear etiology on brain MRI. Follow up revealed no progression.)
First Posted : March 25, 2009
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Tufts Medical Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Arthritis, Juvenile Rheumatoid
Still's Disease, Juvenile Onset
Intervention: Biological: tocilizumab

  Participant Flow

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
Tocilizumab

Single arm study - treatment only

tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.

Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16.

Participant Flow:   Overall Study
    Tocilizumab
STARTED   1 
COMPLETED   0 
NOT COMPLETED   1 



  Baseline Characteristics

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
Tocilizumab

Single arm study - treatment only

tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.

Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16.

Baseline Measures
   Tocilizumab 
Overall Participants Analyzed 
[Units: Participants]
 		 1 
Age 
[Units: Participants]
Count of Participants 		 
<=18 years      0   0.0% 
Between 18 and 65 years      1 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		 
Female      0   0.0% 
Male      1 100.0% 
Region of Enrollment 
[Units: Participants]
 		 
United States   1 


  Outcome Measures

1.  Primary:   Efficacy of Tocilizumab as Defined by Presence of an Equal to or Greater Than 30% Improvement in JIA Core Set (i.e. ACR JIA30 Response)   [ Time Frame: At week 12 of treatment versus week 0 (pretreatment) ]
  Show Outcome Measure 1

2.  Primary:   Efficacy of Tocilizumab as Defined by Reduction of Oral Prednisone Dose by at Least 20%, or to Less Than 0.5mg/kg/Day, Whichever is of Lesser Daily Dose, While Maintaining an ACR JIA30 Response   [ Time Frame: At weeks 12 and 16 of treatment versus week 0 (pretreatment) ]
  Show Outcome Measure 2

3.  Primary:   Number of Participants With at Least One Adverse Event   [ Time Frame: Ongoing, throughout 24 month study period ]
  Show Outcome Measure 3

4.  Secondary:   Measurement of Laboratory Parameters of Active Disease, Specifically C-reactive Protein, Hemoglobin, Platelets, White Blood Cell Count, Ferritin, Immunoglobulins.   [ Time Frame: At weeks 8, 12, and 16 of treatment, and every 8-12 weeks thereafter ]
  Show Outcome Measure 4

5.  Secondary:   Measurement of Sustained Clinical Response to Tocilizumab, Including Active Joint Count, Joints With Limited Range of Motion, and Absence of Fever or Rash.   [ Time Frame: At weeks 8, 12, 16 of treatment, and every 8 weeks thereafter ]
  Show Outcome Measure 5


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Research Administration
Organization: Tufts Medical Center
e-mail: mcoughlin@tuftsmedicalcenter.org


Publications:


Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT00868751     History of Changes
Other Study ID Numbers: TMC-PRHEU-TCZ-01
First Submitted: March 24, 2009
First Posted: March 25, 2009
Results First Submitted: February 1, 2017
Results First Posted: May 15, 2017
Last Update Posted: May 15, 2017