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Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus (SLE) (EMBODY2)

20. november 2020 opdateret af: UCB Pharma

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Four 12-week Treatment Cycles (48 Weeks Total) of Epratuzumab in Systemic Lupus Erythematosus Subjects With Moderate to Severe Disease

The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

791

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Brasilien
      • Belo Horizonte, Brasilien
        • 954
      • Campinas, Brasilien
        • 956
      • Goiânia, Brasilien
        • 955
      • Juiz de Fora, Brasilien
        • 950
      • Rio de Janeiro, Brasilien
        • 952
  • Canada
      • Hamilton, Canada
        • 502
      • London, Canada
        • 500
      • Toronto, Canada
        • 504
      • Victoria, Canada
        • 517
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • 506
    • Ontario
      • Mississauga, Ontario, Canada
        • 507
    • Quebec
      • Rimouski, Quebec, Canada
        • 508
  • Den Russiske Føderation
      • Kemerovo, Den Russiske Føderation
        • 778
      • Kemerovo, Den Russiske Føderation
        • 780
      • Moscow, Den Russiske Føderation
        • 779
  • Det Forenede Kongerige
      • Birmingham, Det Forenede Kongerige
        • 677
      • Christchurch, Det Forenede Kongerige
        • 678
      • London, Det Forenede Kongerige
        • 679
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater
        • 539
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater
        • 557
    • California
      • Hemet, California, Forenede Stater
        • 515
      • Huntington Beach, California, Forenede Stater
        • 544
      • La Jolla, California, Forenede Stater
        • 550
      • Los Angeles, California, Forenede Stater
        • 548
      • San Diego, California, Forenede Stater
        • 589
      • San Leandro, California, Forenede Stater
        • 531
      • Torrance, California, Forenede Stater
        • 558
      • Westlake Village, California, Forenede Stater
        • 594
    • Colorado
      • Denver, Colorado, Forenede Stater
        • 532
    • Connecticut
      • Bridgeport, Connecticut, Forenede Stater
        • 511
    • Florida
      • Brandon, Florida, Forenede Stater
        • 514
      • Fort Lauderdale, Florida, Forenede Stater
        • 533
      • Plantation, Florida, Forenede Stater
        • 518
      • Port Orange, Florida, Forenede Stater
        • 585
      • Tampa, Florida, Forenede Stater
        • 538
    • Georgia
      • Atlanta, Georgia, Forenede Stater
        • 537
      • Decatur, Georgia, Forenede Stater
        • 587
    • Idaho
      • Idaho Falls, Idaho, Forenede Stater
        • 590
    • Kentucky
      • Bowling Green, Kentucky, Forenede Stater
        • 543
      • Lexington, Kentucky, Forenede Stater
        • 592
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater
        • 576
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater
        • 572
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater
        • 554
      • Lansing, Michigan, Forenede Stater
        • 513
      • Lansing, Michigan, Forenede Stater
        • 599
    • Missouri
      • Florissant, Missouri, Forenede Stater
        • 575
      • Saint Louis, Missouri, Forenede Stater
        • 549
    • New Hampshire
      • Nashua, New Hampshire, Forenede Stater
        • 596
    • New Jersey
      • Clifton, New Jersey, Forenede Stater
        • 593
      • Freehold, New Jersey, Forenede Stater
        • 568
    • New York
      • Brooklyn, New York, Forenede Stater
        • 551
      • Lake Success, New York, Forenede Stater
        • 553
      • Manhasset, New York, Forenede Stater
        • 545
      • Roslyn, New York, Forenede Stater
        • 577
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater
        • 559
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater
        • 547
    • Pennsylvania
      • Wyomissing, Pennsylvania, Forenede Stater
        • 561
    • South Carolina
      • Charleston, South Carolina, Forenede Stater
        • 535
      • Myrtle Beach, South Carolina, Forenede Stater
        • 598
    • Tennessee
      • Jackson, Tennessee, Forenede Stater
        • 571
    • Texas
      • Amarillo, Texas, Forenede Stater
        • 574
      • Austin, Texas, Forenede Stater
        • 570
      • Houston, Texas, Forenede Stater
        • 541
      • Houston, Texas, Forenede Stater
        • 563
      • San Antonio, Texas, Forenede Stater
        • 562
    • Virginia
      • Chesapeake, Virginia, Forenede Stater
        • 552
    • Washington
      • Seattle, Washington, Forenede Stater
        • 534
  • Frankrig
      • Caen, Frankrig
        • 613
      • Limoges Cedex, Frankrig
        • 618
      • Montpellier Cedex 5, Frankrig
        • 617
      • Paris, Frankrig
        • 614
      • Toulouse Cedex 9, Frankrig
        • 616
  • Indien
      • Ahmedabad, Indien
        • 852
      • Bangalore, Indien
        • 853
  • Italien
      • Milano, Italien
        • 648
      • Pisa, Italien
        • 647
      • Roma, Italien
        • 646
  • Mexico
      • Cuauhtémoc, Mexico
        • 978
      • Mexico, Mexico
        • 982
      • Mexico City, Mexico
        • 976
      • Torreon, Mexico
        • 981
  • Polen
      • Bydgoszcz, Polen
        • 743
      • Czestochowa, Polen
        • 744
      • Elblag, Polen
        • 752
      • Katowice, Polen
        • 745
      • Katowice, Polen
        • 746
      • Lublin, Polen
        • 748
      • Lublin, Polen
        • 750
      • Poznan, Polen
        • 742
      • Szczecin, Polen
        • 747
      • Ustron, Polen
        • 751
      • Warsaw, Polen
        • 749
  • Rumænien
      • Bucharest, Rumænien
        • 757
      • Bucharest, Rumænien
        • 758
      • Bucharest, Rumænien
        • 760
      • Constanta, Rumænien
        • 759
      • Galati, Rumænien
        • 756
      • Iasi, Rumænien
        • 761
  • Spanien
      • Barcelona, Spanien
        • 661
      • Getafe, Spanien
        • 660
      • Las Palmas de Gran Canaria, Spanien
        • 662
      • Madrid, Spanien
        • 664
      • Santiago de Compostela, Spanien
        • 663
      • Vigo, Spanien
        • 659
  • Sydafrika
      • Cape Town, Sydafrika
        • 901
      • Durban, Sydafrika
        • 902
      • Stellenbosch, Sydafrika
        • 903
  • Tyskland
      • Berlin, Tyskland
        • 628
      • Berlin, Tyskland
        • 633
      • Dessau, Tyskland
        • 636
      • Hamburg, Tyskland
        • 637
      • Herne, Tyskland
        • 632
      • Kiel, Tyskland
        • 629
      • Köln, Tyskland
        • 625
      • Leipzig, Tyskland
        • 626
      • Mainz, Tyskland
        • 634
      • Münster, Tyskland
        • 627
      • Wiesbaden, Tyskland
        • 639
      • Zerbst, Tyskland
        • 631
  • Ukraine
      • Donetsk, Ukraine
        • 791
      • Kiev, Ukraine
        • 790
      • Kiev, Ukraine
        • 794
      • Kiev, Ukraine
        • 797
      • Luhansk, Ukraine
        • 792
      • Odessa, Ukraine
        • 793
      • Vinnytsya, Ukraine
        • 796
  • Ungarn
      • Budapest, Ungarn
        • 712
      • Budapest, Ungarn
        • 716
      • Budapest, Ungarn
        • 718
      • Debrecen, Ungarn
        • 717
      • Szeged, Ungarn
        • 711
      • Szeged, Ungarn
        • 715
      • Zalaegerszeg, Ungarn
        • 713

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Positive antinuclear antibodies (ANA) at Screening (Visit 1)
  • Current clinical diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR) criteria such that at least 4 of the 11 criteria are met
  • Active moderate to severe SLE activity as demonstrated by the British Isles Lupus Assessment Group Index (BILAG)
  • Active moderate to severe SLE disease as demonstrated by SLE disease activity index (SLEDAI) total score
  • On stable SLE treatment regimen, including mandatory corticosteroids and immunosuppressants or antimalarials

Exclusion Criteria:

  • Subjects who are breastfeeding, pregnant, or plan to become pregnant
  • Subjects with active, severe SLE disease activity which involves the renal system
  • Subjects with active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring BILAG level A disease.
  • Subjects with the evidence of an immunosuppressive state
  • Subjects who, in the opinion of the investigator, are at a particularly high risk of significant infection
  • History of malignant cancer, except the following treated cancers: cervical carcinoma in situ, basal cell carcinoma, or dermatological squamous cell carcinoma.
  • Subjects receiving any live vaccination within the 8 weeks prior to screening (Visit 1).
  • Subjects with history of infections, including but not limited to concurrent acute or chronic viral hepatitis B or C
  • Subjects with substance abuse or dependence or other relevant concurrent medical condition
  • Subjects with history of thromboembolic events within 1 year of screening Visit.
  • Subjects with significant hematologic abnormalities
  • Subject has received treatment with other anti- B cell antibodies within 12 months prior to screening (visit 1)
  • Subject use of oral anticoagulant (not including) nonsteroidal anti-inflammatory drugs (NSAIDs) within 12 weeks prior to screening (Visit 1)
  • Subject has previously participated in this study or has previously received epratuzumab treatment.

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo (Weekly infusion)
Placebo infusions delivered weekly for a total of 4 weeks over four 12-week treatment cycles
Medicin: Placebo
Placebo-infusioner givet ugentligt i 4 uger over fire 12-ugers behandlingscyklusser
Eksperimentel: Epratuzumab 600 mg per week
600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12 week treatment cycles
Medicin: Epratuzumab
600 mg infusioner givet ugentligt i i alt 4 uger (kumulativ dosis 2400 mg) over fire 12-ugers behandlingscyklusser
Medicin: Epratuzumab
1200 mg infusioner givet hver anden uge i i alt 4 uger (kumulativ dosis 2400 mg) over fire 12-ugers behandlingscyklusser
Eksperimentel: Epratuzumab 1200 mg every other week
1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles and placebo infusions delivered every other week for a total of 4 weeks over four 12-week treatment cycles
Medicin: Placebo
Placebo-infusioner givet ugentligt i 4 uger over fire 12-ugers behandlingscyklusser
Medicin: Epratuzumab
600 mg infusioner givet ugentligt i i alt 4 uger (kumulativ dosis 2400 mg) over fire 12-ugers behandlingscyklusser
Medicin: Epratuzumab
1200 mg infusioner givet hver anden uge i i alt 4 uger (kumulativ dosis 2400 mg) over fire 12-ugers behandlingscyklusser

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Percent of Subjects Meeting Treatment Response Criteria at Week 48 According to a Combined Response Index
Tidsramme: At Week 48
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
At Week 48

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The Percent of Subjects Meeting Treatment Response Criteria at Week 24 According to a Combined Response Index
Tidsramme: At Week 24
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
At Week 24
The Percent of Subjects Meeting Treatment Response Criteria at Week 12 According to a Combined Response Index
Tidsramme: At Week 12
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
At Week 12
The Percent of Subjects Meeting Treatment Response Criteria at Week 36 According to a Combined Response Index
Tidsramme: At Week 36
Percentages are based on the number of subjects in the relevant treatment group within the Full Analysis Set (FAS). The combined response index incorporated criteria for achievement of responder status from the: British Isles Lupus Assessment Group Index (BILAG-2004)- improvement from study entry or no worsening in other organ systems, Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; Version 2000, also known as SLEDAI-2K) - no worsening compared to study entry, physician's global assessment of disease activity(PGA)- no worsening compared to study entry, and concomitant medications- no changes.
At Week 36
Change From Baseline in Daily Corticosteroid Dose at Week 24
Tidsramme: At Week 24
Participants were grouped into 4 categories: Dose decreased by >50%, Dose decreased >0% to ≤50%, No change in dose and Dose increased or missing data.
At Week 24
Change From Baseline in Daily Corticosteroid Dose at Week 48
Tidsramme: At Week 48
Participants were grouped into 4 categories: Dose decreased by >50%, Dose decreased >0% to ≤50%, No change in dose and Dose increased or missing data.
At Week 48

Samarbejdspartnere og efterforskere

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

Sponsor

UCB Pharma

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. december 2010

Primær færdiggørelse (Faktiske)

1. maj 2015

Studieafslutning (Faktiske)

1. juni 2015

Datoer for studieregistrering

Først indsendt

14. december 2010

Først indsendt, der opfyldte QC-kriterier

15. december 2010

Først opslået (Skøn)

16. december 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. december 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. november 2020

Sidst verificeret

1. november 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SL0010
  • 2010-018565-26 (EudraCT nummer)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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