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Juvenile Rheumatoid ArthritisPhase 3NCT03781375

Etanercept Plus Methotrexate Versus Methotrexate Alone in Children With Polyarticular Course Juvenile Rheumatoid Arthritis

A Phase 3 study testing Etanercept and Methotrexate in people with Juvenile Rheumatoid Arthritis, run by Amgen.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objective of this study was to determine the efficacy of etanercept plus methotrexate vs methotrexate alone in pediatric patients with active polyarticular course juvenile rheumatoid arthritis (JRA). Read more about this study

Who is it for?
Any age
Conditions the study is for
Juvenile Rheumatoid Arthritis
What is being tested?
Etanercept and Methotrexate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
No sites listed yet
Study dates
24 Aug 2000to 24 Jun 2002
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 Any age
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients must have had a diagnosis of JRA by the American College of Rheumatology (ACR) criteria. Disease onset may have been systemic, polyarticular, or pauciarticular
  • Disease course must have been polyarticular with at least 5 active joints
  • Duration of disease was not limited, but must have been long enough for the patient to have been given a 3-month trial of non-steroidal anti-inflammatory drugs (NSAIDs) and methotrexate at a dose between 0.3 and 1.0 mg/kg/week, orally (PO) or subcutaneously (SC)
  • Receiving methotrexate at a dose between 0.3 mg/kg/wk and 1 mg/kg/wk at time of randomization. The dose of methotrexate must have been stable for one month prior to entry
  • Patients may have failed prednisone, or been on a dosage of prednisone not to have exceeded 10 mg/day or 0.20 mg/kg/day (whichever was less)
  • At the time of qualification (screening) for study and prior to wash-out of all disease modifying anti-rheumatic drugs (DMARDs), the patient must have had active disease, defined as ≥ 5 swollen joints accompanied by pain, and/or tenderness and/or warmth, and ≥ 3 joints with limitation of motion (LOM). (The joints with LOM may have been the same as those with swelling)
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  • Had good venous access and stable hematocrit ≥ 24 mL/dL
  • Patients must have been pre-pubescent, or if post-pubertal at anytime during the study, and of child-bearing potential, must have been practicing adequate contraception
  • Parent or legal guardian was able and willing to give informed consent
  • Parent or legal guardian must have been willing to actively supervise storage and administration of study drug and ensure that the date and time of each dose was accurately recorded in the subject's diary

Who cannot join

  • Was unable to meet the concurrent medication restrictions as described in the protocol
  • Pregnant or nursing female
  • Patients were excluded if they demonstrated clinically significant deviations from normal (as defined below) in any of the following laboratory parameters:
  • thrombocytopenia; platelet count < 100,000/cmm
  • leukopenia; total white cell count < 4000 cells/cmm
  • neutropenia; neutrophils < 1000 cells/cmm
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  • hepatic transaminase levels > two times the upper limit of normal (ULN)
  • serum bilirubin > two times the ULN
  • estimated creatinine clearance of < 90 mL/min/1.73 M² body surface area (BSA)
  • known human immunodeficiency virus (HIV), hepatitis B surface antigen positivity not related to vaccination, or hepatitis C antibody positivity
  • Had received etanercept, antibody to tumor necrosis factor (TNF) (i.e. infliximab or D2E7), antibody to cluster of differentiation (CD)4 (anti-CD4), diphtheria interleukin (IL)-2 fusion protein (DAB-IL-2) or leflunomide
  • Had received DMARDs including D-penicillamine, hydroxychloroquine, sulfasalazine, oral or injectable gold, cyclosporin, azathioprine; intravenous immunoglobulin (IV Ig); or broadly immunosuppressant chemotherapeutic agents (e.g. cyclophosphamide, FK506, mycophenolate mofetil [CellCept]), for at least 28 days prior to enrollment and dosing of study drug. All DMARDs, other than methotrexate, must have been washed-out for a minimum of 28 days
  • Had received intraarticular glucocorticoid injection within 28 days prior to enrollment on study
  • Had previously received live virus vaccine within 3 months prior to study entry
  • Had participated in a study of an investigational drug or biologic requiring informed-consent within three months prior to study entry
  • Any concurrent medical condition which would have, in the investigator's opinion, compromised the patient's ability to tolerate the study drug or would have made the patient unable to cooperate with the protocol
  • History of/or current psychiatric illness that would have interfered with ability to comply with protocol requirements or give informed consent
  • Chronic or recurrent infections, or currently active infection at screening
  • History of alcohol or drug abuse that would have interfered with ability to comply with protocol requirements
  • Inability to have complied with the study requirements

About this study

Official title: A Phase III Double Blind Randomized Study Comparing Etanercept (Enbrel) Combined With Methotrexate vs Methotrexate Alone in Children With Polyarticular Course Juvenile Rheumatoid Arthritis

The primary objective of this study was to determine the efficacy of etanercept plus methotrexate vs methotrexate alone in pediatric patients with active polyarticular course juvenile rheumatoid arthritis (JRA).

Being tested
Etanercept, Placebo to Etanerceot, Methotrexate
Medical subject headings
Arthritis, Juvenile

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

  • Placebo to EtanerceotDrug

    Administered by subcutaneous injection twice a week

  • MethotrexateDrug

    Administered orally or subcutaneously once a week at the same dose as prior to study entry

Study groups in NCT03781375
Study groupRoleWhat they receive
Methotrexate + PlaceboPlacebo comparatorParticipants received placebo subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months.
Receives: Drug: Etanercept; Drug: Placebo to Etanerceot; Drug: Methotrexate
Methotrexate + EtanerceptExperimentalParticipants received 0.4 mg/kg etanercept subcutaneous injections twice weekly and methotrexate once a week at the same dose as prior to study entry for 6 months. After month 6 participants received open-label 0.4 mg/kg etanercept twice weekly plus methotrexate for an additional 6 months.
Receives: Drug: Etanercept; Drug: Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With a JRA Response at Month 6

    Response was defined using the JRA definition of improvement (JRA DOI) as a ≥ 30% improvement from baseline in at least three of the six JRA Core Set Criteria and ≥ 30% worsening in not more than one of the six assessments. The JRA Core Set Criteria consist of:

    • Physician's global assessment of disease severity assessed on a visual analog scale (VAS) from 1 to 10
    • Patient's/Parent's global assessment of overall well being assessed on a VAS from 1 to 10
    • Number of active joints (swelling, not due to deformity, or if no swelling is present, limitation of motion accompanied by pain on passive motion and/or tenderness and/or warmth)
    • Number of joints with limitation of motion
    • Childhood Health Assessment Questionnaire (CHAQ)
    • Erythrocyte sedimentation rate (ESR)

    Measured: Baseline and month 6

Secondary outcomes (2)

  1. Percentage of Participants With a 50% Improvement in JRA DOI at Month 6

    Response was defined using the JRA definition of improvement (JRA DOI) as a ≥ 50% improvement from baseline in at least three of the six JRA Core Set Criteria and ≥ 30% worsening in not more than one of the six assessments. The JRA Core Set Criteria consist of:

    • Physician's global assessment of disease severity assessed on a visual analog scale (VAS) from 1 to 10
    • Patient's/Parent's global assessment of overall well being assessed on a VAS from 1 to 10
    • Number of active joints (swelling, not due to deformity, or if no swelling is present, limitation of motion accompanied by pain on passive motion and/or tenderness and/or warmth)
    • Number of joints with limitation of motion
    • Childhood Health Assessment Questionnaire (CHAQ)
    • Erythrocyte sedimentation rate (ESR)

    Measured: Baseline and month 6

  2. Percentage of Participants With a 70% Improvement in JRA DOI at Month 6

    Response was defined using the JRA definition of improvement (JRA DOI) as a ≥ 70% improvement from baseline in at least three of the six JRA Core Set Criteria and ≥ 30% worsening in not more than one of the six assessments. The JRA Core Set Criteria consist of:

    • Physician's global assessment of disease severity assessed on a visual analog scale (VAS) from 1 to 10
    • Patient's/Parent's global assessment of overall well being assessed on a VAS from 1 to 10
    • Number of active joints (swelling, not due to deformity, or if no swelling is present, limitation of motion accompanied by pain on passive motion and/or tenderness and/or warmth)
    • Number of joints with limitation of motion
    • Childhood Health Assessment Questionnaire (CHAQ)
    • Erythrocyte sedimentation rate (ESR)

    Measured: Baseline and month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2018
  2. Study start24 Aug 2000
  3. Primary completion20 Jun 2002
  4. Study completion24 Jun 2002

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03781375
Sponsor's protocol ID
20021628
Other IDs
016.0028
Status last verified
Jun 2019
First submitted
18 Dec 2018
Last updated
2 Aug 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etanercept and Methotrexate 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 10 inclusion and 20 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 2 Aug 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 2 Aug 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?

Percentage of Participants With a JRA Response at Month 6 (time frame: Baseline and month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03781375.

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 2 Aug 2019.

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