A Phase 3 interventional study of Etanercept and Placebo in Juvenile Rheumatoid Arthritis, sponsored by Amgen. Terminated. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-09-25.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
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).
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 Participants who did not meet the response criteria in Part 1A or Part 1B of the study were to be withdrawn from the study as non-responders.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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
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EXCLUSION CRITERIA:
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.
Drug: Etanercept
Participants who met response criteria in Part 1 were randomized to receive placebo twice a week for up to 3 months.
Drug: Placebo
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.
Drug: Etanercept
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.
Drug: Etanercept
Administered by subcutaneous injection twice a week
Also known as: Enbrel
Administered by subcutaneous injection twice a week
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)
Time frame: 3 months during Part 2 (depending on the timing of response, entry into Part 2 was between study months 3 and 10)
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 to flare was defined as the time from first dose of etanercept in Part 1 to the date of flare during 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
Physician global assessment of disease severity assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms).
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
Physician global assessment of disease severity assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms).
Time frame: 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).
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
Patient's/parent's global assessment of overall well-being assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms).
Time frame: 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.
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
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.
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
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).
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
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).
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
Participants with systemic onset juvenile rheumatoid arthritis (SOJRA) were enrolled at 7 sites in the United States and 4 sites in Canada.
| Milestone | Part 1: Etanercept | Part 2: Placebo | Part 2: Etanercept | Part 3: Etanercept |
|---|---|---|---|---|
| Started | 19 | 0 | 0 | 0 |
| Completed | 9 | 0 | 0 | 0 |
| Not completed | 10 | 0 | 0 | 0 |
| Withdrew: Adverse event | 2 | 0 | 0 | 0 |
| Withdrew: Lack of efficacy | 7 | 0 | 0 | 0 |
| Withdrew: Other | 1 | 0 | 0 | 0 |
| Milestone | Part 1: Etanercept | Part 2: Placebo | Part 2: Etanercept | Part 3: Etanercept |
|---|---|---|---|---|
| Started | 10 | 0 | 0 | 0 |
| Completed | 2 | 0 | 0 | 0 |
| Not completed | 8 | 0 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 | 0 |
| Withdrew: Lack of efficacy | 7 | 0 | 0 | 0 |
| Milestone | Part 1: Etanercept | Part 2: Placebo | Part 2: Etanercept | Part 3: Etanercept |
|---|---|---|---|---|
| Started | 0 | 6 | 4 | 0 |
| Received study drug | 0 | 5 | 4 | 0 |
| Completed | 0 | 5 | 4 | 0 |
| Not completed | 0 | 1 | 0 | 0 |
| Withdrew: Adverse event | 0 | 1 | 0 | 0 |
| Milestone | Part 1: Etanercept | Part 2: Placebo | Part 2: Etanercept | Part 3: Etanercept |
|---|---|---|---|---|
| Started | 0 | 0 | 0 | 9 |
| Completed | 0 | 0 | 0 | 9 |
| Not completed | 0 | 0 | 0 | 0 |
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)
| Participants | Part 2: Placebo | Part 2: Etanercept |
|---|---|---|
| Number of Participants in Part 2 With Disease Flare | 1 | 0 |
| Participants | Part 1A: Etanercept 0.4 mg/kg | Part 1B: Etanercept 0.8 mg/kg | Part 2: Placebo | Part 2: Etanercept | Part 3: Etanercept |
|---|---|---|---|---|---|
| Non-infectious adverse events | 16 | 3 | 2 | 2 | 4 |
| Infectious adverse events | 14 | 2 | 4 | 1 | 3 |
Time to flare was defined as the time from first dose of etanercept in Part 1 to the date of flare during Part 2.
| days | Part 2: Placebo | Part 2: Etanercept |
|---|---|---|
| Time to Flare in Part 2 | 180 (180 to 180) | — |
Physician global assessment of disease severity assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms).
| units on a scale | Part 1: Etanercept |
|---|---|
| Month 1 | -1.42 ± 2.34 |
| Month 2 | -2.21 ± 2.57 |
| Month 3 | -1.26 ± 2.62 |
| Month 4 | -1.82 ± 2.53 |
| Month 5 | -2.13 ± 2.36 |
| Month 6 | -1.64 ± 2.58 |
| Month 7 | -0.40 ± 1.82 |
| Month 8 | 0.50 ± 2.12 |
| Month 9 | 0.00 ± 1.41 |
Physician global assessment of disease severity assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms).
| units on a scale | Part 2: Placebo | Part 2: Etanercept |
|---|---|---|
| Month 5 | -1.00 ± NA | -4.00 ± NA |
| Month 6 | -0.50 ± 2.12 | -3.00 ± 1.41 |
| Month 7 | -3.67 ± 1.53 | -4.25 ± 0.50 |
| Month 8 | -4.00 ± 1.83 | -2.67 ± 2.52 |
| Month 9 | -4.67 ± 1.53 | -6.00 ± NA |
Patient's/parent's global assessment of overall well-being assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms).
| units on a scale | Part 1: Etanercept |
|---|---|
| Month 1 | -1.88 ± 2.52 |
| Month 2 | -2.38 ± 2.63 |
| Month 3 | -1.44 ± 3.46 |
| Month 4 | -2.50 ± 2.62 |
| Month 5 | -2.54 ± 2.93 |
| Month 6 | -2.89 ± 2.09 |
| Month 7 | -2.00 ± 3.32 |
| Month 8 | -0.50 ± 0.71 |
| Month 9 | 0.00 ± NA |
Patient's/parent's global assessment of overall well-being assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms).
| units on a scale | Part 2: Placebo | Part 2: Etanercept |
|---|---|---|
| Month 5 | 0.00 ± NA | -7.00 ± NA |
| Month 6 | -3.00 ± 4.24 | -5.00 ± 2.83 |
| Month 7 | -3.33 ± 0.58 | -4.25 ± 1.89 |
| Month 8 | -4.25 ± 2.22 | -2.67 ± 2.31 |
| Month 9 | -5.33 ± 0.58 | -5.00 ± NA |
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.
| active joints | Part 1: Etanercept |
|---|---|
| Month 1 | -1.94 ± 6.65 |
| Month 2 | -6.75 ± 10.35 |
| Month 3 | -3.50 ± 18.89 |
| Month 4 | -3.21 ± 5.42 |
| Month 5 | -5.46 ± 9.20 |
| Month 6 | -1.55 ± 8.72 |
| Month 7 | -1.83 ± 5.19 |
| Month 8 | -1.67 ± 8.08 |
| Month 9 | -4.00 ± 4.24 |
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.
| active joints | Part 2: Placebo | Part 2: Etanercept |
|---|---|---|
| Month 5 | -12.00 ± NA | — |
| Month 6 | -11.50 ± 7.78 | -11.00 ± 12.73 |
| Month 7 | -6.33 ± 4.51 | -17.00 ± 9.90 |
| Month 8 | -4.67 ± 2.08 | -13.00 ± 5.00 |
| Month 9 | -25.00 ± NA | — |
| joints | Part 1: Etanercept |
|---|---|
| Month 1 | 0.50 ± 7.34 |
| Month 2 | -0.19 ± 6.49 |
| Month 3 | 1.88 ± 15.11 |
| Month 4 | 1.27 ± 7.71 |
| Month 5 | -0.92 ± 3.78 |
| Month 6 | 2.56 ± 7.06 |
| Month 7 | -0.40 ± 6.15 |
| Month 8 | -1.33 ± 7.64 |
| Month 9 | -5.50 ± 6.36 |
| joints | Part 2: Placebo | Part 2: Etanercept |
|---|---|---|
| Month 5 | 4.0 ± NA | -2.00 ± NA |
| Month 6 | 4.50 ± 2.12 | 26.00 ± NA |
| Month 7 | 2.67 ± 4.73 | -3.00 ± 5.94 |
| Month 8 | 1.75 ± 4.86 | 1.00 ± 8.19 |
| Month 9 | -8.00 ± 13.89 | — |
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).
| units on a scale | Part 1: Etanercept |
|---|---|
| Month 1 | -0.35 ± 0.74 |
| Month 2 | -0.30 ± 0.68 |
| Month 3 | -0.27 ± 0.72 |
| Month 4 | -0.29 ± 0.73 |
| Month 5 | -0.47 ± 0.84 |
| Month 6 | -0.57 ± 1.15 |
| Month 7 | -0.29 ± 0.66 |
| Month 8 | -0.06 ± 1.50 |
| Month 9 | 0.25 ± 1.06 |
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).
| units on a scale | Part 2: Placebo | Part 2: Etanercept |
|---|---|---|
| Month 5 | 0.0 ± NA | -1.63 ± NA |
| Month 6 | -0.06 ± 0.09 | -0.75 ± 1.24 |
| Month 7 | -1.08 ± 1.23 | -0.63 ± 1.18 |
| Month 8 | -1.09 ± 1.19 | -0.29 ± 0.56 |
| Month 9 | -1.54 ± 1.44 | -1.50 ± NA |
| mg/dL | Part 1: Etanercept |
|---|---|
| Month 1 | -4.13 ± 6.10 |
| Month 2 | -4.23 ± 9.53 |
| Month 3 | -4.04 ± 6.80 |
| Month 4 | -6.03 ± 7.66 |
| Month 5 | -3.07 ± 3.71 |
| Month 6 | -5.97 ± NA |
| mg/dL | Part 2: Placebo | Part 2: Etanercept |
|---|---|---|
| Month 5 | -0.44 ± NA | — |
| Month 6 | 1.88 ± NA | -0.77 ± NA |
| Month 7 | — | -3.43 ± 3.60 |
| Month 8 | — | -3.43 ± 3.60 |
| Month 9 | — | -5.97 ± NA |
Collected over 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 one month after the last dose of study drug.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1A: Etanercept 0.4 mg/kg | — | 3/19 (15.8%) | 18/19 (94.7%) |
| Part 1B: Etanercept 0.8 mg/kg | — | 1/8 (12.5%) | 4/8 (50%) |
| Part 2: Placebo | — | 0/5 (0%) | 4/5 (80%) |
| Part 2: Etanercept 0.4/0.8 mg/kg | — | 0/4 (0%) | 3/4 (75%) |
| Part 3: Etanercept 0.4/0.8 mg/kg | — | 0/9 (0%) | 5/9 (55.6%) |
| Event | Part 1A: Etanercept 0.4 mg/kg | Part 1B: Etanercept 0.8 mg/kg | Part 2: Placebo | Part 2: Etanercept 0.4/0.8 mg/kg | Part 3: Etanercept 0.4/0.8 mg/kg |
|---|---|---|---|---|---|
| PleurisyRespiratory, thoracic and mediastinal disorders | 0/19 | 1/8 | 0/5 | 0/4 | 0/9 |
| AnaemiaBlood and lymphatic system disorders | 1/19 | 0/8 | 0/5 | 0/4 | 0/9 |
| GastroenteritisInfections and infestations | 1/19 | 0/8 | 0/5 | 0/4 | 0/9 |
| Rheumatoid arthritisMusculoskeletal and connective tissue disorders | 1/19 | 0/8 | 0/5 | 0/4 | 0/9 |
| Event | Part 1A: Etanercept 0.4 mg/kg | Part 1B: Etanercept 0.8 mg/kg | Part 2: Placebo | Part 2: Etanercept 0.4/0.8 mg/kg | Part 3: Etanercept 0.4/0.8 mg/kg |
|---|---|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 6/19 | 2/8 | 2/5 | 0/4 | 2/9 |
| Injection site reactionGeneral disorders | 7/19 | 0/8 | 0/5 | 1/4 | 2/9 |
| HeadacheNervous system disorders | 6/19 | 0/8 | 1/5 | 0/4 | 1/9 |
| DiarrhoeaGastrointestinal disorders | 2/19 | 0/8 | 0/5 | 1/4 | 0/9 |
| NasopharyngitisInfections and infestations | 0/19 | 0/8 | 0/5 | 1/4 | 0/9 |
| CheilosisGastrointestinal disorders | 1/19 | 0/8 | 1/5 | 0/4 | 0/9 |
| Injection site rashGeneral disorders | 1/19 | 0/8 | 1/5 | 0/4 | 0/9 |
| Otitis mediaInfections and infestations | 1/19 | 0/8 | 1/5 | 0/4 | 0/9 |
| PharyngitisInfections and infestations | 1/19 | 0/8 | 1/5 | 0/4 | 0/9 |
| Skin lesionSkin and subcutaneous tissue disorders | 0/19 | 0/8 | 1/5 | 0/4 | 0/9 |
All enrolled participants
| Age, Continuous(years) | Part 1: Etanercept |
|---|---|
| Mean | 9.05 ± 4.20 |
| Sex: Female, Male(Participants) | Part 1: Etanercept |
|---|---|
| Female | 10 |
| Male | 9 |
| Race/Ethnicity, Customized(Participants) | Part 1: Etanercept |
|---|---|
| White | 15 |
| Hispanic | 2 |
| Other | 2 |
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