This open-label extension of the JIGSAW studies (WA28117 \[NCT01904279\] and WA28118 \[NCT01904292\]) is designed to evaluate the long-term safety and efficacy of subcutaneous (SC) tocilizumab treatment in participants with polyarticular-course and systemic juvenile idiopathic arthritis (pJIA and sJIA). Participants from the 2 JIGSAW studies will continue to receive 162 milligrams (mg) of SC tocilizumab with treatment schedule according to arthritis subtype and body weight. Participants will receive the treatment until commercial availability of the drug or for a maximum of 5 years, whichever is earlier.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
82
162 mg tocilizumab will be administered by SC injection at the following intervals: pJIA participants less than (\<) 30 kilograms (kg): every 3 weeks; pJIA participants greater than or equal to (\>=) 30 kg: every 2 weeks; sJIA participants \<30 kg: every 2 weeks; sJIA participants \>/= 30 kg: once weekly
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States
University of Chicago Hospital
Chicago, Illinois, United States
Hackensack University Medical Center; Pediatric Rheumatology
Hackensack, New Jersey, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children'S Hospital Medical Center; Division of Rheumatology
Cincinnati, Ohio, United States
Juvenile Arthritis Disease Activity Score (JADAS-71)
Time frame: Baseline up to 3 years
Percentage of Participants With Adverse Events (AEs), Serious AEs (AEs) and AEs of Special Interest
Time frame: Baseline up to 5 years
Childhood Health Assessment Questionnaire (CHAQ) Score
Time frame: Baseline up to 3 years
Percentage of Participants With Protocol Defined Inactive Disease/Clinical Remission
Time frame: Baseline up to 3 years
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Cleveland Clinic Fndn
Cleveland, Ohio, United States
Healthcare Research Consultants
Tulsa, Oklahoma, United States
University of Utah; Immunology/Rheumatology/Allergy
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
Hospital Gral de Niños Pedro Elizalde
Buenos Aires, Argentina
...and 21 more locations