Juvenile Rheumatoid ArthritisPhase 3NCT00078806
Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis
A Phase 3 study testing Etanercept in people with Juvenile Rheumatoid Arthritis, run by Amgen.
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). Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Juvenile Rheumatoid Arthritis
- What is being tested?
- Etanercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- 4 Jun 2001to 6 May 2004
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
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- Diabetes that requires insulin treatment
- Infection, chronic, recurrent, or currently active
- Any serious medical or psychiatric condition or history of alcohol or drug abuse
About this study
Official title: A Phase 3 Safety and Efficacy Study of Etanercept In Children With Systemic Onset Juvenile Rheumatoid Arthritis
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).
Read the 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.
- Conditions
- Juvenile Rheumatoid Arthritis
- Being tested
- Etanercept, Placebo
- Keywords
- Systemic Onset Juvenile Rheumatoid Arthritis, SOJRA, Fever, Rash, Joint Pain
- Medical subject headings
- Arthritis, Juvenile, Fever, Exanthema, Arthralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Also called Enbrel
Administered by subcutaneous injection twice a week
PlaceboDrug
Administered by subcutaneous injection twice a week
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Etanercept | Experimental | 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. Receives: Drug: Etanercept |
| Part 2: Placebo | Placebo comparator | Participants who met response criteria in Part 1 were randomized to receive placebo twice a week for up to 3 months. Receives: Drug: Placebo |
| Part 2: Etanercept | Experimental | 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. Receives: Drug: Etanercept |
| Part 3: | Experimental | 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. Receives: Drug: Etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months during Part 2 (depending on the timing of response, entry into Part 2 was between study months 3 and 10)
Secondary outcomes (14)
Number of Participants With Adverse Events
Measured: 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 to flare was defined as the time from first dose of etanercept in Part 1 to the date of flare during Part 2.
Measured: 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
Physician global assessment of disease severity assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms).
Measured: 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
Physician global assessment of disease severity assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms).
Measured: Baseline and months 5, 6, 7, 8, and 9
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).
Measured: 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
Patient's/parent's global assessment of overall well-being assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms).
Measured: Baseline and months 5, 6, 7, 8, and 9
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.
Measured: Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9
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.
Measured: Baseline and months 5, 6, 7, 8, and 9
Change From Baseline in Number of Joints With Limitation of Motion in Part 1
Measured: 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
Measured: Baseline and months 5, 6, 7, 8, and 9
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).
Measured: 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
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).
Measured: Baseline and months 5, 6, 7, 8, and 9
Change From Baseline in C-reactive Protein (CRP) Levels in Part 1
Measured: 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
Measured: Baseline and months 5, 6, 7, 8, and 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2004 (estimated)
- Study start4 Jun 2001
- Primary completion6 May 2004
- Study completion6 May 2004
Why it stopped: the study was terminated because of slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Juvenile Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Immunex Corporation
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00078806
- Sponsor's protocol ID
- 20021631
- Status last verified
- Aug 2019
- First submitted
- 5 Mar 2004
- Last updated
- 25 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Safety and Efficacy Study of Etanercept In Children With Systemic Onset Juvenile Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00078806
- Acronym / sponsor ID
- 20021631
- Conditions
- Juvenile Rheumatoid Arthritis
- Keywords
- Systemic Onset Juvenile Rheumatoid Arthritis, SOJRA, Fever, Rash, Joint Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the study was terminated because of slow enrollment
- Enrolment
- 19 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Collaborators
- Immunex Corporation
- Study start
- 4 Jun 2001 (actual)
- Primary completion
- 6 May 2004 (actual)
- Study completion
- 6 May 2004 (actual)
- First posted
- 9 Mar 2004 (estimated)
- Results
- Posted 25 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: Etanercept | Experimental | Drug: EtanerceptParticipants 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. |
| Part 2: Placebo | Placebo comparator | Drug: PlaceboParticipants who met response criteria in Part 1 were randomized to receive placebo twice a week for up to 3 months. |
| Part 2: Etanercept | Experimental | Drug: EtanerceptParticipants 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. |
| Part 3: | Experimental | Drug: EtanerceptParticipants 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. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtanerceptAlso: EnbrelAdministered by subcutaneous injection twice a week | Drug | Part 1: Etanercept, Part 2: Etanercept, Part 3: |
| PlaceboAdministered by subcutaneous injection twice a week | Drug | Part 2: Placebo |
Primary outcome
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: * 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)
14 secondary outcomes
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.
Time to Flare in Part 2
Time frame: 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
Change From Baseline in Physician Global Assessment of Disease Severity in Part 2
Time frame: 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
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
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
Change From Baseline in Number of Active Joints in Part 2
Time frame: 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
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
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
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
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
Change From Baseline in C-reactive Protein (CRP) Levels in Part 2
Time frame: Baseline and months 5, 6, 7, 8, and 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- FDA-approved Drug LabelingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Etanercept in people with Juvenile Rheumatoid Arthritis, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.