- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00078806
Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis
A Phase 3 Safety and Efficacy Study of Etanercept In Children With Systemic Onset Juvenile Rheumatoid Arthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part 1: Etanercept
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. |
Administered by subcutaneous injection twice a week
Other Names:
|
Placebo Comparator: Part 2: Placebo
Participants who met response criteria in Part 1 were randomized to receive placebo twice a week for up to 3 months.
|
Administered by subcutaneous injection twice a week
|
Experimental: Part 2: Etanercept
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.
|
Administered by subcutaneous injection twice a week
Other Names:
|
Experimental: Part 3:
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.
|
Administered by subcutaneous injection twice a week
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants in Part 2 With Disease Flare
Time Frame: 3 months during Part 2 (depending on the timing of response, entry into Part 2 was between study months 3 and 10)
|
Disease flare was defined as the presence of:
Major Criteria:
Laboratory Criteria: All labs should be outside the normal range and with 30% worsening:
|
3 months during Part 2 (depending on the timing of response, entry into Part 2 was between study months 3 and 10)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events
Time Frame: 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.
|
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.
|
|
Time to Flare in Part 2
Time Frame: From first dose in Part 1 to the end of Part 2 (up to 13 months)
|
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)
|
Change From Baseline in Physician Global Assessment of Disease Severity in Part 1
Time Frame: Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9
|
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
|
Change From Baseline in Physician Global Assessment of Disease Severity in Part 2
Time Frame: Baseline and months 5, 6, 7, 8, and 9
|
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
|
Change From Baseline in Patient's/Parent's Global Assessment in Part 1
Time Frame: Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9
|
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
|
Change From Baseline in Patient's/Parent's Global Assessment of Disease Severity in Part 2
Time Frame: Baseline and months 5, 6, 7, 8, and 9
|
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
|
Change From Baseline in Number of Active Joints in Part 1
Time Frame: Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9
|
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
|
Change From Baseline in Number of Active Joints in Part 2
Time Frame: Baseline and months 5, 6, 7, 8, and 9
|
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
|
Change From Baseline in Number of Joints With Limitation of Motion in Part 1
Time Frame: Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9
|
Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9
|
|
Change From Baseline in Number of Joints With Limitation of Motion in Part 2
Time Frame: Baseline and months 5, 6, 7, 8, and 9
|
Baseline and months 5, 6, 7, 8, and 9
|
|
Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 1
Time Frame: Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9
|
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
|
Change From Baseline in Childhood Health Assessment Questionnaire (CHAQ) Disability Index in Part 2
Time Frame: Baseline and months 5, 6, 7, 8, and 9
|
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
|
Change From Baseline in C-reactive Protein (CRP) Levels in Part 1
Time Frame: Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9
|
Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9
|
|
Change From Baseline in C-reactive Protein (CRP) Levels in Part 2
Time Frame: Baseline and months 5, 6, 7, 8, and 9
|
Baseline and months 5, 6, 7, 8, and 9
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Arthritis, Juvenile
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gastrointestinal Agents
- Etanercept
Other Study ID Numbers
- 20021631
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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