Trial · NCT00078806
Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis
NCT00078806, Phase 3, Terminated, Amgen; results first posted 2019-09-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis. Trials, record NCT00078806. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00078806
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis
- NCT number
- NCT00078806
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 19 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Juvenile Rheumatoid Arthritis
- Interventions
- Etanercept, Placebo
- First posted
- 2004-03-09
- Last updated
- 2019-09-25
- Results first posted
- 2019-09-25
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants in Part 2 With Disease Flare | 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) |
| 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 | 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. |
| Secondary | Change From Baseline in Physician Global Assessment of Disease Severity in Part 1 | 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). |
| Secondary | Change From Baseline in Physician Global Assessment of Disease Severity in Part 2 | 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). |
| Secondary | Change From Baseline in Patient's/Parent's Global Assessment in Part 1 | 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). |
| Secondary | Change From Baseline in Patient's/Parent's Global Assessment of Disease Severity in Part 2 | 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). |
| Secondary | Change From Baseline in Number of Active Joints in Part 1 | 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. |
| Secondary | Change From Baseline in Number of Active Joints in Part 2 | 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. |
| 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 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants in Part 2 With Disease Flare | 3 months during Part 2 (depending on the timing of response, entry into Part 2 was between study months 3 and 10) | Participants randomized into Part 2 who received at least 1 dose of study drug in Part 2 (placebo or etanercept). | Participants | COUNT_OF_PARTICIPANTS |
| 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. | Participants who entered each part of the study and received study drug in each part of the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Flare in Part 2 | From first dose in Part 1 to the end of Part 2 (up to 13 months) | Participants randomized in Part 2 with a flare in Part 2 | days | MEDIAN |
| SECONDARY | Change From Baseline in Physician Global Assessment of Disease Severity in Part 1 | Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Participants who enrolled in the study and received at least one dose of etanercept in Part 1A or Part 1B and with available data at each time point. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Physician Global Assessment of Disease Severity in Part 2 | Baseline and months 5, 6, 7, 8, and 9 | Participants who randomized and received at least one dose of study drug in Part 2 and with available data at each time point; participants could join Part 2 at different times depending on their response status. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Patient's/Parent's Global Assessment in Part 1 | Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Participants who enrolled in the study and received at least one dose of etanercept in Part 1A or Part 1B and with available data at baseline and each time point. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Patient's/Parent's Global Assessment of Disease Severity in Part 2 | Baseline and months 5, 6, 7, 8, and 9 | Participants who randomized and received at least one dose of study drug in Part 2 and with available data at each time point; participants could join Part 2 at different times depending on their response status. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Number of Active Joints in Part 1 | Baseline and months 1, 2, 3, 4, 5, 6, 7, 8, and 9 | Participants who enrolled in the study and received at least one dose of etanercept in Part 1A or Part 1B and with available data at baseline and each time point. | active joints | MEAN |
| SECONDARY | Change From Baseline in Number of Active Joints in Part 2 | Baseline and months 5, 6, 7, 8, and 9 | Participants who randomized and received at least one dose of study drug in Part 2 and with available data at each time point; participants could join Part 2 at different times depending on their response status. | active joints | MEAN |
| 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 | Participants who enrolled in the study and received at least one dose of etanercept in Part 1A or Part 1B and with available data at baseline and each time point. | joints | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group117
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants in Part 2 With Disease Flare | Part 2: Placebo | 1 | Participants | ||
| Number of Participants in Part 2 With Disease Flare | Part 2: Etanercept | 0 | Participants | ||
| Number of Participants With Adverse Events | Part 1A: Etanercept 0.4 mg/kg | Non-infectious adverse events | 16 | Participants | |
| Number of Participants With Adverse Events | Part 1B: Etanercept 0.8 mg/kg | Non-infectious adverse events | 3 | Participants | |
| Number of Participants With Adverse Events | Part 2: Placebo | Non-infectious adverse events | 2 | Participants | |
| Number of Participants With Adverse Events | Part 2: Etanercept | Non-infectious adverse events | 2 | Participants | |
| Number of Participants With Adverse Events | Part 3: Etanercept | Non-infectious adverse events | 4 | Participants | |
| Number of Participants With Adverse Events | Part 1A: Etanercept 0.4 mg/kg | Infectious adverse events | 14 | Participants | |
| Number of Participants With Adverse Events | Part 1B: Etanercept 0.8 mg/kg | Infectious adverse events | 2 | Participants | |
| Number of Participants With Adverse Events | Part 2: Placebo | Infectious adverse events | 4 | Participants |
1 to 10 of 117Source ClinicalTrials.gov
See all 117 results by groupParticipant flow52
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1A | STARTED | Part 1: Etanercept | 19 | |
| Part 1A | STARTED | Part 2: Placebo | 0 | |
| Part 1A | STARTED | Part 2: Etanercept | 0 | |
| Part 1A | STARTED | Part 3: Etanercept | 0 | |
| Part 1A | COMPLETED | Part 1: Etanercept | 9 | |
| Part 1A | COMPLETED | Part 2: Placebo | 0 | |
| Part 1A | COMPLETED | Part 2: Etanercept | 0 | |
| Part 1A | COMPLETED | Part 3: Etanercept | 0 | |
| Part 1A | NOT COMPLETED | Part 1: Etanercept | 10 | |
| Part 1A | NOT COMPLETED | Part 2: Placebo | 0 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 participant flowAdverse events280
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Part 1A: Etanercept 0.4 mg/kg | 1 | 19 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 1B: Etanercept 0.8 mg/kg | 0 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2: Placebo | 0 | 5 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 2: Etanercept 0.4/0.8 mg/kg | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Part 3: Etanercept 0.4/0.8 mg/kg | 0 | 9 | |
| other | Ear pain | Ear and labyrinth disorders | Part 1A: Etanercept 0.4 mg/kg | 1 | 19 | |
| other | Ear pain | Ear and labyrinth disorders | Part 1B: Etanercept 0.8 mg/kg | 0 | 8 | |
| other | Ear pain | Ear and labyrinth disorders | Part 2: Placebo | 0 | 5 | |
| other | Ear pain | Ear and labyrinth disorders | Part 2: Etanercept 0.4/0.8 mg/kg | 0 | 4 | |
| other | Ear pain | Ear and labyrinth disorders | Part 3: Etanercept 0.4/0.8 mg/kg | 0 | 9 |
1 to 10 of 280Source ClinicalTrials.gov
See all 280 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1A: Etanercept 0.4 mg/kg | ||
| Total, all-cause mortality | Part 1B: Etanercept 0.8 mg/kg | ||
| Total, all-cause mortality | Part 2: Placebo | ||
| Total, all-cause mortality | Part 2: Etanercept 0.4/0.8 mg/kg | ||
| Total, all-cause mortality | Part 3: Etanercept 0.4/0.8 mg/kg | ||
| Total, other adverse events | Part 1A: Etanercept 0.4 mg/kg | 18 | 19 |
| Total, other adverse events | Part 1B: Etanercept 0.8 mg/kg | 4 | 8 |
| Total, other adverse events | Part 2: Placebo | 4 | 5 |
| Total, other adverse events | Part 2: Etanercept 0.4/0.8 mg/kg | 3 | 4 |
| Total, other adverse events | Part 3: Etanercept 0.4/0.8 mg/kg | 5 | 9 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Part 2: Etanercept vs Part 2: Placebo: Number of Participants in Part 2 With Disease Flare |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00078806
GET https://conductscience.org/api/trials/v1/NCT00078806/results?page=2