Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis
Juvenile Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Juvenile Rheumatoid Arthritis focused on measuring Systemic Onset Juvenile Rheumatoid Arthritis, SOJRA, Fever, Rash, Joint Pain
Eligibility Criteria
INCLUSION CRITERIA: 2 - 18 years of age SOJRA for at least 3 months, with stable systemic features If taking methotrexate, hydroxychloroquine, or NSAIDs, dose must be stable Must take prednisone at a stable dose EXCLUSION CRITERIA: Need for other DMARDs or prestudy requirements for oral or parenteral pulse steroids or intra-articular steroids Pregnant or nursing female Clinically significant abnormal laboratory test results for blood cells, liver or kidney function, or serology Previous receipt of any tumor necrosis factor (TNF) inhibitor Live virus vaccine within 12 weeks of study entry Participation in another study requiring informed consent within 12 weeks of entry Diabetes that requires insulin treatment Infection, chronic, recurrent, or currently active Any serious medical or psychiatric condition or history of alcohol or drug abuse
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Experimental
Part 1: Etanercept
Part 2: Placebo
Part 2: Etanercept
Part 3:
Participants received 0.4 mg/kg etanercept administered subcutaneously twice a week for up to 6 months in Part 1A. Participants who had a partial response entered Part 1B and received 0.8 mg/kg etanercept twice weekly for up to 4 months.
Participants who met response criteria in Part 1 were randomized to receive placebo twice a week for up to 3 months.
Participants who met response criteria in Part 1 were randomized to continue receiving etanercept twice a week at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to 3 months.
Participants who experienced a flare or completed 3 months of treatment in Part 2 entered Part 3 and received open-label treatment with etanercept at the same dose as in Part 1 (0.4 or 0.8 mg/kg) for up to a maximum of 12 months, including treatment in Part 2.