A Phase 2/3 interventional study of Etanercept and Placebo in Juvenile Rheumatoid Arthritis, sponsored by Amgen. Completed. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2019-08-02.
Sponsored by Amgen · Phase 2/3, Interventional, and Treatment
The primary objective of this study was to determine the efficacy of etanercept in children with polyarticular course JRA.
This was a two-part study. In the first part of the study, all participants received open-label etanercept twice a week for 90 days. At the end of the 90 days, participants with disease response as defined by the JRA Definition of Improvement (DOI) using the JRA Core Set Criteria were randomized in part 2 of the study to receive placebo or continued administration of etanercept until either disease flare occurred or 4 months elapsed, whichever was earlier.
Participants who did not meet the DOI at day 90, participants who had disease flare during part 2 and participants who completed the blinded part of the study were eligible to receive open-label treatment with etanercept under protocol 16.0018 (NCT00357903).
3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.
This study's enrollment of 69 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Clinically significant deviations from normal, defined as:
Participants received 0.4 mg/kg etanercept twice weekly for 90 days during Part 1. In Part 2 participants were randomized to receive placebo subcutaneous injection twice weekly for up to 4 months.
Drug: Etanercept · Drug: Placebo
Participants received 0.4 mg/kg etanercept twice weekly for 90 days during Part 1. In Part 2 participants were randomized to continue receiving etanercept twice weekly for up to 4 additional months.
Drug: Etanercept
Administered twice weekly by subcutaneous injection
Also known as: Enbrel, TNFR:Fc
Administered twice weekly by subcutaneous injection
Percentage of Participants With Disease Flare in Part 2
Disease flare was defined as a 30% or greater worsening in three of the six JRA Core Set Criteria and ≥ 30% improvement in one or less of the six JRA Core Set Criteria compared to day 90 and a minimum of two active joints (joints with swelling or limitation of movement plus pain and/or tenderness). The JRA Core Set criteria consisted of: * Physician global assessment of disease severity assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms); * Patient/parent global assessment of overall well-being assesses on a VAS from 0 (asymptomatic) to 10 (severe symptoms); * Number of active joints; * Number of joints with limitation of motion (LOM) and with pain, tenderness, or both; * Childhood Health Assessment Questionnaire (CHAQ) disability domain; * Erythrocyte sedimentation rate (ESR).
Time frame: End of part 1 (day 90) and months 4 to 7
Time to Flare in Part 2
The time from day 90 to flare. Participants who withdrew without flare were censored at the time of withdrawal.
Time frame: Months 4 to 7
Number of Participants With Adverse Events
Time frame: Part 1: 90 days (months 1-3) plus 30 days for participants who were not randomized into part 2. Part 2: From first dose of randomized treatment to 30 days after last dose (150 days; months 4-8).
Participants were enrolled at 9 sites in the United States and Canada. The study consisted of an open-label treatment period (part 1) where all participants received 0.4 mg etanercept twice weekly for 3 months, followed by a randomized double-blind treatment period (part 2).
| Milestone | Part 1: Etanercept 0.4 mg/kg | Part 2: Placebo | Part 2: Etanercept 0.4 mg/kg |
|---|---|---|---|
| Started | 69 | 0 | 0 |
| Completed | 64 | 0 | 0 |
| Not completed | 5 | 0 | 0 |
| Withdrew: Adverse event | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 |
| Withdrew: Withdrawal by parent/guardian | 1 | 0 | 0 |
| Withdrew: Response status | 2 | 0 | 0 |
| Milestone | Part 1: Etanercept 0.4 mg/kg | Part 2: Placebo | Part 2: Etanercept 0.4 mg/kg |
|---|---|---|---|
| Started | 0 | 26 | 25 |
| Completed | 0 | 7 | 19 |
| Not completed | 0 | 19 | 6 |
| Withdrew: Withdrawal by parent/guardian | 0 | 1 | 0 |
| Withdrew: Response status | 0 | 18 | 6 |
Disease flare was defined as a 30% or greater worsening in three of the six JRA Core Set Criteria and ≥ 30% improvement in one or less of the six JRA Core Set Criteria compared to day 90 and a minimum of two active joints (joints with swelling or limitation of movement plus pain and/or tenderness). The JRA Core Set criteria consisted of: * Physician global assessment of disease severity assessed on a visual analog scale (VAS) from 0 (asymptomatic) to 10 (severe symptoms); * Patient/parent global assessment of overall well-being assesses on a VAS from 0 (asymptomatic) to 10 (severe symptoms); * Number of active joints; * Number of joints with limitation of motion (LOM) and with pain, tenderness, or both; * Childhood Health Assessment Questionnaire (CHAQ) disability domain; * Erythrocyte sedimentation rate (ESR).
| percentage of participants | Part 2: Placebo | Part 2: Etanercept 0.4 mg/kg |
|---|---|---|
| Percentage of Participants With Disease Flare in Part 2 | 81 | 28 |
The time from day 90 to flare. Participants who withdrew without flare were censored at the time of withdrawal.
| days | Part 2: Placebo | Part 2: Etanercept 0.4 mg/kg |
|---|---|---|
| Time to Flare in Part 2 | 28.0 (6 to 123) | 116.0 (28 to 127) |
| Participants | Part 1: Etanercept 0.4 mg/kg | Part 2: Placebo | Part 2: Etanercept 0.4 mg/kg |
|---|---|---|---|
| Noninfectious adverse events | 51 | 9 | 13 |
| Injection site reactions | 27 | 1 | 1 |
| Infections | 43 | 8 | 15 |
| Serious adverse events | 1 | 0 | 1 |
| Deaths | 0 | 0 | 0 |
Collected over Part 1: 90 days (months 1-3) plus 30 days for participants who were not randomized into part 2. Part 2: From first dose of randomized treatment to 30 days after last dose (150 days; months 4-8).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part 1: Etanercept 0.4 mg/kg | — | 1/69 (1.4%) | 59/69 (85.5%) |
| Part 2: Placebo | — | 0/26 (0%) | 12/26 (46.2%) |
| Part 2: Etanercept 0.4 mg/kg | — | 1/25 (4%) | 19/25 (76%) |
| Event | Part 1: Etanercept 0.4 mg/kg | Part 2: Placebo | Part 2: Etanercept 0.4 mg/kg |
|---|---|---|---|
| Abnormal behaviourPsychiatric disorders | 0/69 | 0/26 | 1/25 |
| GastroenteritisInfections and infestations | 1/69 | 0/26 | 0/25 |
| Event | Part 1: Etanercept 0.4 mg/kg | Part 2: Placebo | Part 2: Etanercept 0.4 mg/kg |
|---|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 24/69 | 4/26 | 10/25 |
| Injection site erythemaGeneral disorders | 23/69 | 1/26 | 0/25 |
| HeadacheNervous system disorders | 14/69 | 3/26 | 5/25 |
| Injection site pruritusGeneral disorders | 13/69 | 1/26 | 0/25 |
| Injection site swellingGeneral disorders | 13/69 | 1/26 | 1/25 |
| VomitingGastrointestinal disorders | 10/69 | 0/26 | 3/25 |
| Injection site painGeneral disorders | 10/69 | 1/26 | 0/25 |
| PharyngitisInfections and infestations | 10/69 | 0/26 | 3/25 |
| GastroenteritisInfections and infestations | 5/69 | 1/26 | 3/25 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 4/69 | 0/26 | 3/25 |
Baseline data are included for all enrolled participants in part 1 (69) and all participants who randomized in part 2 (51).
| Age, Continuous(years) | Part 1: Etanercept 0.4 mg/kg | Part 2: Placebo | Part 2: Etanercept 0.4 mg/kg | Total |
|---|---|---|---|---|
| Part 1 | 10.5 ± 3.9 | — | — | 10.5 ± 3.9 |
| Part 2 | — | 12.2 ± 3.5 | 8.9 ± 3.7 | 10.6 ± 3.9 |
| Age, Customized(Participants) | Part 1: Etanercept 0.4 mg/kg | Part 2: Placebo | Part 2: Etanercept 0.4 mg/kg | Total |
|---|---|---|---|---|
| Part 1 — 4 - 8 years | 25 | — | — | 25 |
| Part 1 — 9 - 12 years | 14 | — | — | 14 |
| Part 1 — 13 - 17 years | 30 | — | — | 30 |
| Part 2 — 4 - 8 years | — | 5 | 13 | 18 |
| Part 2 — 9 - 12 years | — | 4 | 5 | 9 |
| Part 2 — 13 - 17 years | — | 17 | 7 | 24 |
| Sex: Female, Male(Participants) | Part 1: Etanercept 0.4 mg/kg | Part 2: Placebo | Part 2: Etanercept 0.4 mg/kg | Total |
|---|---|---|---|---|
| Part 1 — Female | 43 | — | — | 43 |
| Part 1 — Male | 26 | — | — | 26 |
| Part 2 — Female | — | 15 | 19 | 34 |
| Part 2 — Male | — | 11 | 6 | 17 |
| Race/Ethnicity, Customized(Participants) | Part 1: Etanercept 0.4 mg/kg | Part 2: Placebo | Part 2: Etanercept 0.4 mg/kg | Total |
|---|---|---|---|---|
| Part 1 — Black | 6 | — | — | 6 |
| Part 1 — White | 52 | — | — | 52 |
| Part 1 — Asian | 1 | — | — | 1 |
| Part 1 — Hispanic | 9 | — | — | 9 |
| Part 1 — Native American | 1 | — | — | 1 |
| Part 2 — Black | — | 1 | 3 | 4 |
| Part 2 — White | — | 23 | 14 | 37 |
| Part 2 — Asian | — | 0 | 1 | 1 |
| Part 2 — Hispanic | — | 2 | 6 | 8 |
| Part 2 — Native American | — | 0 | 1 | 1 |
| Type of Onset of Juvenile Rheumatoid Arthritis (JRA)(Participants) | Part 1: Etanercept 0.4 mg/kg | Part 2: Placebo | Part 2: Etanercept 0.4 mg/kg | Total |
|---|---|---|---|---|
| Part 1 — Pauciarticular | 7 | — | — | 7 |
| Part 1 — Polyarticular | 40 | — | — | 40 |
| Part 1 — Systemic | 22 | — | — | 22 |
| Part 2 — Pauciarticular | — | 1 | 2 | 3 |
| Part 2 — Polyarticular | — | 17 | 14 | 31 |
| Part 2 — Systemic | — | 8 | 9 | 17 |
No study locations are listed for this record.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Amgen