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Safety and Efficacy of Etanercept (Recombinant Human Tumor Necrosis Factor Receptor Fusion Protein [TNFR:Fc]) in Children With Juvenile Rheumatoid Arthritis (JRA)

10. juni 2019 opdateret af: Amgen

Safety, Population Pharmacokinetics, and Efficacy of Recombinant Human Tumor Necrosis Factor Receptor Fusion Protein (TNFR:Fc) in Children With Juvenile Rheumatoid Arthritis

The primary objective of this study was to determine the efficacy of etanercept in children with polyarticular course JRA.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

69

Fase

  • Fase 2
  • Fase 3

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

4 år til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Diagnosis of JRA by the American College of Rheumatology (ACR) criteria.
  • Disease course must be polyarticular with disease duration long enough to have been given an adequate trial of non-steroidal anti-inflammatory drugs (NSAIDs) and low-dose methotrexate at a dose of at least 10 mg/m²/week
  • Continuing active disease, defined as ≥ 5 swollen joints and ≥ 3 joints with limitation of motion accompanied by pain, tenderness or warmth.
  • Disease refractory to methotrexate or intolerant of methotrexate.
  • Have not received disease-modifying anti-rheumatic drugs (DMARDs) within 28 days prior to enrollment.
  • Have not received methotrexate within 14 days prior to dosing of study drug.

Exclusion Criteria:

  • Pregnant or nursing female
  • Functional class IV by ACR criteria
  • Unable to meet concomitant medication restrictions
  • Intraarticular corticosteroid injection within 4 weeks prior to enrollment

  • Clinically significant deviations from normal, defined as:

    • thrombocytopenia; platelet count < 100,000/cmm
    • leukopenia; total white cell count < 4000 cells/cmm
    • neutropenia; neutrophils < 1000 cells/cmm
    • hepatic transaminase levels > two times the upper limit of normal (ULN)
    • serum bilirubin > 2 times ULN
    • creatinine clearance < 90 mL/min/1.73 m² body surface area (BSA) and/or a glomerular filtration rate (GFR) < 90 mL/min/1.73 m² BSA.
    • known human immunodeficiency virus (HIV), hepatitis B surface antigen positivity, or hepatitis C positivity.
    • anti-double-stranded deoxyribonucleic acid (dsDNA) antibodies or anti-cardiolipin antibodies present.
  • Previously received antibody to TNF, antibody to cluster of differentiation (CD)4, or diphtheria interleukin (IL)-2-fusion protein (DAB-IL-2)
  • Participated in a study of an investigational drug or biologic requiring informed consent within 3 months prior to study entry.
  • Any concurrent medical condition which would, in the investigator's opinion, compromise the patient's ability to tolerate the study drug or make the patient unable to cooperate with the protocol.
  • History of or current psychiatric illness that would interfere with ability to comply with protocol requirements or informed consent.
  • History or drug or alcohol abuse that would interfere with ability to comply with protocol requirements

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Etanercept/Placebo
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.
Medicin: Etanercept
Administered twice weekly by subcutaneous injection
Andre navne:
  • Enbrel
  • TNFR:Fc
Medicin: Placebo
Administered twice weekly by subcutaneous injection
Eksperimentel: Etanercept/Etanercept
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.
Medicin: Etanercept
Administered twice weekly by subcutaneous injection
Andre navne:
  • Enbrel
  • TNFR:Fc

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Disease Flare in Part 2
Tidsramme: End of part 1 (day 90) and months 4 to 7

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).
End of part 1 (day 90) and months 4 to 7

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Flare in Part 2
Tidsramme: Months 4 to 7
The time from day 90 to flare. Participants who withdrew without flare were censored at the time of withdrawal.
Months 4 to 7
Number of Participants With Adverse Events
Tidsramme: 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).
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).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Amgen

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 1997

Primær færdiggørelse (Faktiske)

8. juli 1998

Studieafslutning (Faktiske)

8. juli 1998

Datoer for studieregistrering

Først indsendt

18. december 2018

Først indsendt, der opfyldte QC-kriterier

18. december 2018

Først opslået (Faktiske)

19. december 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. august 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2019

Sidst verificeret

1. juni 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20021616
  • 016.0016 (Anden identifikator: Immunex Corporation)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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