A Study of Subcutaneously Administered Tocilizumab in Participants With Systemic Juvenile Idiopathic Arthritis



Status:Completed
Conditions:Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:1 - 17
Updated:11/22/2017
Start Date:August 15, 2013
End Date:June 13, 2017

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A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Systemic Juvenile Idiopathic Arthritis

This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics, and
safety of subcutaneously administered tocilizumab in participants with Systemic Juvenile
Idiopathic Arthritis (sJIA). Participants with body weight less than (<) 30 kilograms (kg)
will receive subcutaneous (SC) tocilizumab dose every 2 weeks (Q2W) and participants with
body weight greater than or equal to (>=) 30 kg will receive weekly (QW), for 52 weeks.
Tocilizumab was administered every 10 days until pre-planned interim analysis was performed
and changed to Q2W in participants with body weight <30 kg.


Inclusion Criteria:

- Diagnosis of sJIA according to the International League of Associations for
Rheumatology (ILAR) classification

- History of inadequate clinical response (in the opinion of the treating physician) to
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and corticosteroids

- If a participant has received previous treatment with any biologic agents other than
tocilizumab, these must have been discontinued according to the timelines defined by
protocol prior to the baseline visit

- Participants currently receiving tocilizumab by the intravenous (IV) route of
administration and with well-controlled disease do not require a period of
discontinuation of IV tocilizumab and should have their first dose of SC tocilizumab
administered on the date that their next IV tocilizumab infusion would be due

- Concurrent treatment with Disease Modifying Anti-Rheumatic Drugs (DMARDs) including
methotrexate (MTX), NSAIDs, and oral corticosteroids are permitted at the discretion
of the investigator

- Participants of reproductive potential must be willing to use highly effective
contraceptive methods

Exclusion Criteria:

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

- Participants with poorly controlled disease (in the opinion of the treating physician)
despite current treatment with IV tocilizumab

- sJIA that is well controlled by any treatment agent other than tocilizumab (Juvenile
Arthritis Disease Activity Score of 71 Joints [JADAS-71] less than or equal to [<=]
3.8 with no fever)

- Participants who are wheelchair-bound or bedridden

- Any other auto-immune, rheumatic disease, or overlapping syndrome other than sJIA

- Lack of recovery from recent surgery or an interval of <6 weeks since surgery at the
time of the screening visit

- Females who are pregnant, lactating, or intending to become pregnant during study
conduct

- Any significant concurrent medical or surgical condition that would jeopardize the
participant's safety or ability to complete the study

- Known Human Immunodeficiency Virus (HIV) infection or other acquired forms of immune
compromise or inborn conditions characterized by a compromised immune system

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

- Any active acute, subacute, chronic, or recurrent bacterial, viral, or systemic fungal
infection or any major episode of infection requiring hospitalization or treatment
during screening or treatment with IV antibiotics completed within 4 weeks of the
screening visit or oral antibiotics completed within 2 weeks of the screening visit

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

- Positive TB test at screening unless treated with anti-TB therapy for at least 4 weeks
prior to receiving study drug

- History of reactivation or new onset of a systemic infection such as herpes zoster or
Epstein-Barr virus within 2 months of the screening visit

- Hepatitis B surface antigen or hepatitis C antibody positivity or chronic viral or
autoimmune hepatitis

- 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

- Macrophage activation syndrome (MAS) within 3 months of the screening visit

- Inadequate hematologic, renal or liver function
We found this trial at
12
sites
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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Buenos Aires,
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Charlotte, NC
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Chicago, IL
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5801 South Ellis Avenue
Chicago, Illinois 60649
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Cincinnati, OH
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9500 Euclid Avenue
Cleveland, Ohio 44195
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30 Prospect Avenue
Hackensack, New Jersey 07601
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Hackensack, NJ
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282 Washington Street
Hartford, Connecticut 06106
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Little Rock, AR
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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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