Clinical trial NCT00078806: Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis
Official title: A Phase 3 Safety and Efficacy Study of Etanercept In Children With Systemic Onset Juvenile Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Juvenile Rheumatoid Arthritis
Keywords: Systemic Onset Juvenile Rheumatoid Arthritis
SOJRA
Fever
Rash
Joint Pain
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Immunex Corporation
First posted: 2004-03-09
Enrollment: 19
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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 Participants who did not meet the response criteria in Part 1A or Part 1B of the study were to be withdrawn from the study as non-responders.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.

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

Primary outcomes:
measure: Number of Participants in Part 2 With Disease Flare
timeFrame: 3 months during Part 2 (depending on the timing of response, entry into Part 2 was between study months 3 and 10)
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Part 1A, maximum duration on treatment was 207 days; Part 1B, maximum duration on treatment was 120 days; Part 2, maximum duration on treatment was 88 days; Part 3, maximum duration on treatment was 130 days; plus 30 days after last dose of study drug.
measure: Time to Flare in Part 2
timeFrame: From first dose in Part 1 to the end of Part 2 (up to 13 months)
measure: Change From Baseline in Physician Global Assessment of Disease Severity in Part 1
timeFrame: Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9
measure: Change From Baseline in Physician Global Assessment of Disease Severity in Part 2
timeFrame: Baseline and months 5, 6, 7, 8, and 9
measure: Change From Baseline in Patient's/Parent's Global Assessment in Part 1
timeFrame: Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9
measure: Change From Baseline in Patient's/Parent's Global Assessment of Disease Severity in Part 2
timeFrame: Baseline and months 5, 6, 7, 8, and 9
measure: Change From Baseline in Number of Active Joints in Part 1
timeFrame: Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9
measure: Change From Baseline in Number of Active Joints in Part 2
timeFrame: Baseline and months 5, 6, 7, 8, and 9
measure: Change From Baseline in Number of Joints With Limitation of Motion in Part 1
timeFrame: Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9
measure: Change From Baseline in Number of Joints With Limitation of Motion in Part 2
timeFrame: Baseline and months 5, 6, 7, 8, and 9
measure: Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 1
timeFrame: Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9
measure: Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2
timeFrame: Baseline and months 5, 6, 7, 8, and 9
measure: Change From Baseline in C-reactive Protein (CRP) Levels in Part 1
timeFrame: Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9
measure: Change From Baseline in C-reactive Protein (CRP) Levels in Part 2
timeFrame: Baseline and months 5, 6, 7, 8, and 9
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: