Extension Study Evaluating the Safety and Efficacy of Subcutaneous Tocilizumab (RoActemra/Actemra) Administration in Systemic and Polyarticular-Course Juvenile Idiopathic Arthritis



Status:Active, not recruiting
Conditions:Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:2 - 18
Updated:2/21/2019
Start Date:July 16, 2014
End Date:September 15, 2020

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Long-Term Extension Study to Evaluate the Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic Arthritis

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.


Inclusion Criteria:

- Completion of either of the JIGSAW studies, study WA28117 (for participants with pJIA)
or study WA28118 (for participants with sJIA)

- Adequate disease control with the use of SC tocilizumab(TCZ)(comparable to the use of
IV TCZ, if received prior to enrollment in the JIGSAW study), per clinical judgment of
the investigator

- For participants of reproductive potential: agreement to remain abstinent or use of
effective contraception as defined by the study protocol

Exclusion Criteria:

- Prior discontinuation of SC tocilizumab because of inadequate clinical response during
participation in a JIGSAW study

- Poorly controlled disease (in opinion of treating physician) despite treatment with SC
tocilizumab in the JIGSAW study

- Prior discontinuation of intravenous tocilizumab because of inadequate clinical
response or safety events (including hypersensitivity)

- Therapy with biologic agents (except tocilizumab) in the period between completion of
the JIGSAW study and screening for the current study

- Concurrent treatment with disease-modifying anti-rheumatic drugs (DMARDs) (including
methotrexate), nonsteroidal anti-inflammatory drugs (NSAIDs), and oral corticosteroids
is permitted at the discretion of the investigator

- Use of live or attenuated vaccines and immunosuppressants, such as cyclosporine and
cyclophosphamide

- Any significant concurrent medical or surgical conditions or findings that would
jeopardize the participant's safety or ability to complete the study, including but
not limited to disease of the nervous, renal, hepatic, cardiac, pulmonary, gastric, or
endocrine system or any infection

- History of alcohol, drug, or chemical abuse within 6 months prior to screening

- History of atypical tuberculosis (TB) or active TB requiring treatment within 2 years
prior to screening

- Known human immunodeficiency virus infection or other acquired forms of immune
compromise or inborn conditions characterized by a compromised immune system

- Clinical signs or symptoms of acute or chronic viral hepatitis or chronic autoimmune
hepatitis arising since enrollment in the JIGSAW study

- History of concurrent serious gastrointestinal disorders, such as ulcer or
inflammatory bowel disease, Crohn's disease, ulcerative colitis, or other symptomatic
lower gastrointestinal conditions

- History of or current cancer or lymphoma

- Uncontrolled diabetes mellitus with elevated glycosylated hemoglobin (HbA1c), defined
with the use of age-specific standards

- Any abnormal laboratory values, an elevation of hepatic transaminases ([aspartate
aminotransferase [AST] or alanine aminotransferase [ALT]), lowering of neutrophil
count, or thrombocytopenia attributed to tocilizumab use by investigator at screening,
the participant may be enrolled; however, the initial tocilizumab dose may be delayed
to adhere to the protocol risk mitigation strategy or per the investigator's clinical
judgment

- Prior stem cell transplant at any time
We found this trial at
10
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Little Rock, AR
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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Buenos Aires,
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Chicago, Illinois 60637
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Chicago, IL
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Cincinnati, OH
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9500 Euclid Avenue
Cleveland, Ohio 44195
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Cleveland, OH
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30 Prospect Avenue
Hackensack, New Jersey 07601
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Hackensack, NJ
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Salt Lake City, UT
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4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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Seattle, WA
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Tulsa, Oklahoma 74135
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Tulsa, OK
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