Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis

Amgen

Status and phase: Terminated; Phase 3

Conditions: Juvenile Rheumatoid Arthritis

Treatments: Drug: Etanercept; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00078806

20021631

Details and patient eligibility

About

The primary objective of this study was to determine the efficacy of etanercept in pediatric patients with systemically active system onset juvenile rheumatoid arthritis (SOJRA).

Full description

Participants were to receive etanercept at a dose of 0.4 mg/kg twice weekly in Part 1A. Participants who had a partial response (not able to reduce prednisone dose by 50% of the baseline dose in 5 months) while on 0.4 mg/kg twice weekly etanercept in Part 1A were to enter Part 1B for up to 4 months and were to have the dose of etanercept increased to 0.8 mg/kg twice weekly. Participants who did not meet the response criteria in Part 1A or Part 1B of the study were to be withdrawn from the study as non-responders. Participants who responded in either Part 1A or Part 1B were randomized into Part 2, where they received etanercept or matching placebo in a double-blind manner twice weekly for up to 3 months. In Part 2, participants were stratified by the dosage of etanercept (0.4 mg/kg or 0.8 mg/kg) they were receiving in Part 1A or Part 1B. Participants could enter Part 3, the open-label re-treatment portion of the study, only if they had been entered into Part 2 of the study and had either flared in Part 2 or had completed 3 months of treatment in Part 2. The maximum time participants could receive etanercept in Part 2 and Part 3 combined was 12 months.

Enrollment: 19 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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19 participants in 4 patient groups, including a placebo group

Part 1: Etanercept

Experimental group

Description:

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.

Treatment:

Drug: Etanercept

Part 2: Placebo

Placebo Comparator group

Description:

Participants who met response criteria in Part 1 were randomized to receive placebo twice a week for up to 3 months.

Treatment:

Drug: Placebo

Part 2: Etanercept

Experimental group

Description:

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.

Treatment:

Drug: Etanercept

Part 3:

Experimental group

Description:

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.

Treatment:

Drug: Etanercept