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

Juvenile Rheumatoid Arthritis Clinical Trial

Official title:

A Phase 3 Safety and Efficacy Study of Etanercept In Children With Systemic Onset Juvenile Rheumatoid Arthritis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00078806
• Other study ID #: 20021631
• Status: Terminated
• Phase: Phase 3
• Start date: June 4, 2001
• Est. completion date: May 6, 2004

Study information

• Verified date: August 2019
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 Participants who did not meet the response criteria in Part 1A or Part 1B of the study were to be withdrawn from the study as non-responders.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

Other known NCT identifiers

• NCT00039949

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: May 6, 2004
• Est. primary completion date: May 6, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Arthritis, Rheumatoid
• Juvenile Rheumatoid Arthritis

Intervention

Drug:
• Etanercept
Administered by subcutaneous injection twice a week
• Placebo
Administered by subcutaneous injection twice a week

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Amgen	Immunex Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants in Part 2 With Disease Flare	Disease flare was defined as the presence of: 1 major flare criterion plus 1 minor flare criterion or 1 lab criterion, OR; 2 minor flare criteria plus 2 lab criteria; Major Criteria: Fever of SOJRA, defined as a spike in axillary temperature = 100°F (38°C) for = 2 days per week in the prior 2 weeks or 8 days during the prior month; Symptomatic serositis documented by x-ray or other imaging modality Minor Flare Criteria; Rash of SOJRA, documented in the daily diary; Splenomegaly defined as spleen palpable > 2 cm below the left costal margin; Lymphadenopathy defined as = 1 cm in > 1 node area; Arthritis defined as = 2 active joints with swelling not due to deformity, or if swelling is absent, then 2 joints with loss of motion with pain on passive motion and/or warmth.; Laboratory Criteria: All labs should be outside the normal range and with 30% worsening: Albumin; Platelet count; Hemoglobin; C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR)	3 months during Part 2 (depending on the timing of response, entry into Part 2 was between study months 3 and 10)
Secondary	Number of Participants With Adverse Events		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.
Secondary	Time to Flare in Part 2	Time to flare was defined as the time from first dose of etanercept in Part 1 to the date of flare during Part 2.	From first dose in Part 1 to the end of Part 2 (up to 13 months)
Secondary	Change From Baseline in Physician Global Assessment of Disease Severity in Part 1	Physician global assessment of disease severity assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms).	Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary	Change From Baseline in Physician Global Assessment of Disease Severity in Part 2	Physician global assessment of disease severity assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms).	Baseline and months 5, 6, 7, 8, and 9
Secondary	Change From Baseline in Patient's/Parent's Global Assessment in Part 1	Patient's/parent's global assessment of overall well-being assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms).	Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary	Change From Baseline in Patient's/Parent's Global Assessment of Disease Severity in Part 2	Patient's/parent's global assessment of overall well-being assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms).	Baseline and months 5, 6, 7, 8, and 9
Secondary	Change From Baseline in Number of Active Joints in Part 1	Active joints are those with swelling not due to bony deformity or if swelling is absent, loss of motion (LOM) accompanied by pain on passive motion and/or tenderness and/or warmth.	Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary	Change From Baseline in Number of Active Joints in Part 2	Active joints are those with swelling not due to bony deformity or if swelling is absent, loss of motion (LOM) accompanied by pain on passive motion and/or tenderness and/or warmth.	Baseline and months 5, 6, 7, 8, and 9
Secondary	Change From Baseline in Number of Joints With Limitation of Motion in Part 1		Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary	Change From Baseline in Number of Joints With Limitation of Motion in Part 2		Baseline and months 5, 6, 7, 8, and 9
Secondary	Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 1	Childhood Health Assessment Questionnaire (CHAQ) disability index is used to assess physical functioning in children with arthritis. The scale consists of 30 questions in 8 domains (dressing, grooming, arising, eating, walking, reach, grip, and activities). Each question is scored on a scale from 0 to 3, where 0 = Without any difficulty; 1 = With some difficulty; 2 = With much difficulty; 3 = Unable to do. The overall score ranges from 0 (no difficulty) to 3 (unable to do).	Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary	Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2	Childhood Health Assessment Questionnaire (CHAQ) disability index is used to assess physical functioning in children with arthritis. The scale consists of 30 questions in 8 domains (dressing, grooming, arising, eating, walking, reach, grip, and activities). Each question is scored on a scale from 0 to 3, where 0 = Without any difficulty; 1 = With some difficulty; 2 = With much difficulty; 3 = Unable to do. The overall score ranges from 0 (no difficulty) to 3 (unable to do).	Baseline and months 5, 6, 7, 8, and 9
Secondary	Change From Baseline in C-reactive Protein (CRP) Levels in Part 1		Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Secondary	Change From Baseline in C-reactive Protein (CRP) Levels in Part 2		Baseline and months 5, 6, 7, 8, and 9

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling
•   Notice regarding posted summaries of trial results
•   To access clinical trial results information click on this link