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GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia

20. september 2019 oppdatert av: GlaxoSmithKline
The purpose of this study is to evaluate the efficacy and safety of belimumab in addition to standard therapy compared to placebo in subjects in Northeast Asia with systemic lupus erythematosus (SLE) over a 52 week period.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The purpose of this study is to demonstrate the efficacy and safety of belimumab 10mg/kg administered intravenously (IV) every 4 weeks compared to placebo, in patients with SLE when added to standard of care therapy, as measured by the SLE Responder Index (SRI) at 52 weeks, defined by a composite endpoint using SELENA SLEDAI score, Physician's Global Assessment (PGA) and BILAG A and B organ domain scores.

Studietype

Intervensjonell

Registrering (Faktiske)

709

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Japan
      • Chiba, Japan, 275-8580
        • GSK Investigational Site
      • Ehime, Japan, 791-0295
        • GSK Investigational Site
      • Fukuoka, Japan, 807-8555
        • GSK Investigational Site
      • Fukuoka, Japan, 810-8563
        • GSK Investigational Site
      • Hiroshima, Japan, 730-8619
        • GSK Investigational Site
      • Hiroshima, Japan, 739-0002
        • GSK Investigational Site
      • Hokkaido, Japan, 060-8648
        • GSK Investigational Site
      • Hokkaido, Japan, 060-8604
        • GSK Investigational Site
      • Hyogo, Japan, 675-8545
        • GSK Investigational Site
      • Miyagi, Japan, 980-8574
        • GSK Investigational Site
      • Nagasaki, Japan, 852-8501
        • GSK Investigational Site
      • Nagasaki, Japan, 857-1195
        • GSK Investigational Site
      • Okayama, Japan, 710-0824
        • GSK Investigational Site
      • Okinawa, Japan, 901-0243
        • GSK Investigational Site
      • Tochigi, Japan, 321-0293
        • GSK Investigational Site
      • Tokyo, Japan, 113-8431
        • GSK Investigational Site
  • Kina
      • Beijing, Kina, 100044
        • GSK Investigational Site
      • Beijing, Kina, 100029
        • GSK Investigational Site
      • Beijing, Kina, 100032
        • GSK Investigational Site
      • Chongqing, Kina, 400038
        • GSK Investigational Site
      • Shanghai, Kina, 200025
        • GSK Investigational Site
      • Shanghai, Kina, 200433
        • GSK Investigational Site
      • Shanghai, Kina, 200001
        • GSK Investigational Site
      • Shanghai, Kina, 200003
        • GSK Investigational Site
      • Tianjin, Kina, 300052
        • GSK Investigational Site
    • Anhui
      • Hefei, Anhui, Kina, 230001
        • GSK Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510080
        • GSK Investigational Site
      • Guangzhou, Guangdong, Kina, 510630
        • GSK Investigational Site
      • Guangzhou, Guangdong, Kina, 510260
        • GSK Investigational Site
    • Heilongjiang
      • Harbin, Heilongjiang, Kina, 150001
        • GSK Investigational Site
    • Hunan
      • Changsha, Hunan, Kina, 410011
        • GSK Investigational Site
      • Changsha, Hunan, Kina, 410008
        • GSK Investigational Site
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210029
        • GSK Investigational Site
      • Suzhou, Jiangsu, Kina, 215006
        • GSK Investigational Site
    • Shaanxi
      • Xian, Shaanxi, Kina, 710032
        • GSK Investigational Site
    • Shandong
      • Jinan, Shandong, Kina, 250012
        • GSK Investigational Site
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • GSK Investigational Site
    • Yunnan
      • Kunming, Yunnan, Kina, 650101
        • GSK Investigational Site
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310009
        • GSK Investigational Site
  • Korea, Republikken
      • Busan, Korea, Republikken
        • GSK Investigational Site
      • Daegu, Korea, Republikken, 700-721
        • GSK Investigational Site
      • Incheon, Korea, Republikken, 400-711
        • GSK Investigational Site
      • Seoul, Korea, Republikken, 137-701
        • GSK Investigational Site
      • Seoul, Korea, Republikken, 110-744
        • GSK Investigational Site
      • Seoul, Korea, Republikken
        • GSK Investigational Site
      • Seoul, Korea, Republikken, 133-792
        • GSK Investigational Site
      • Suwon, Kyonggi-do, Korea, Republikken, 443-721
        • GSK Investigational Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Age 18 years and older.
  • Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria.
  • Have active SLE disease.
  • Have positive anti-nuclear antibody (ANA) test results.
  • Are on a stable SLE treatment regimen.
  • Females of childbearing age are willing to use appropriate contraception

Exclusion Criteria:

  • Have received treatment with any B cell targeted therapy at any time.
  • Have received a biologic investigational agent in the past year.
  • Have received 3 or more courses of systemic corticosteroids in the past year.
  • Have received intravenous (IV) cyclophosphamide within 180 days prior to Day 0.
  • Have severe lupus kidney disease.
  • Have active central nervous system (CNS) lupus.
  • Have had a major organ transplant.
  • Have significant unstable or uncontrolled acute or chronic diseases or conditions not due to SLE.
  • Have a planned surgical procedure.
  • Cancer within the last 5 years, except for adequately treated skin cancer, or carcinoma in situ of the uterine cervix.
  • Have required management of acute or chronic infections in the past 60 days.
  • Have current drug or alcohol abuse or dependence.
  • Have a historically positive test, or test positive at screening for HIV, Hepatitis B, or Hepatitis C.
  • Have an IgA deficiency.
  • Have severe laboratory Abnormalities.
  • Have had anaphylactic reaction to X-ray contrast agents or biologic agents.
  • Suicidal behavior or ideation.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
placebo
Legemiddel: Placebo
Administered intravenously. Dosing at Weeks 0, 2, and 4, and then every 4 weeks through Week 48, with a final evaluation at Week 52. All study subjects will receive standard SLE therapies during the study.
Eksperimentell: Belimumab
10 mg/kg
Legemiddel: Belimumab
10mg/kg administered intravenously. Dosing at Weeks 0, 2, and 4, then every 4 weeks through Week 48, with a final evaluation at Week 52. All study subjects will receive standard SLE therapies during the study.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52 for Double-blind Phase.
Tidsramme: Week 52
SRI response is a composite index, defined as the percent of participants with >=4 point reduction from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score and no worsening (increase of < 0.30 points from Baseline) in physicians global assessment (PGA) and no new British isles lupus assessment group (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).
Week 52

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percent of Participants With >=4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52 for Double-blind Phase.
Tidsramme: Baseline (Day 0) and Week 52
The SELENA SLEDAI score is a weighted index for assessing SLE disease activity in which signs and symptoms, laboratory tests and physician's assessment for each of 9 organ system were given a weighted score and summed if present at the time of the visit or in the preceding 10 days. A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. A decrease of 4 points or more equates to a clinically meaningful improvement. The Baseline value of a variable is defined as the value of the variable measured at Day 0 prior to dosing. In case of multiple results on Day 0 prior to dosing, the latest result was used. If a Day 0 value was not available, the last available value prior to Day 0 was used.
Baseline (Day 0) and Week 52
Percent of Participants With SRI7 Response at Week 52 for Double-blind Phase.
Tidsramme: Baseline (Day 0) and Week 52
SRI7 response is defined as the percent of participants with >=7 point reduction from Baseline in SELENA SLEDAI score and no worsening (increase of < 0.30 points from Baseline) in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at the time of assessment (at Week 52 of the blinded period). A SELENA SLEDAI score of 0 would suggest no lupus activity; while a score of 105 is the maximum calculable if all items were scored as being present from active lupus. PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range. The higher thresholds of SELENA SLEDAI improvement (i.e., SRI5, SRI6, and SRI7) indicates a higher response (SRI5 is a 5 point SELENA SLEDAI reduction, SRI6 is a 6 point reduction, and SRI7 is a 7 point reduction).
Baseline (Day 0) and Week 52
Number of Days of Daily Prednisone Dose <=7.5 mg/Day and/or Reduced by 50 Percent From Baseline Over 52 Weeks for Double-blind Phase.
Tidsramme: Week 52
Number of days of daily prednisone dose <=7.5 mg/day and/or reduced by 50 percent over time through each scheduled visit during the blinded period were compared between belimumab and placebo using Rank ANCOVA model which was used for comparing belimumab and placebo. The independent variables in the model included treatment group, Baseline prednisone dose level, country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4). This analysis was perfomed on the participants who used prednisone >7.5 mg/day at Baseline.
Week 52
Time to First Severe SLE Flare Index (SFI) Flare Over 52 Weeks for Double-blind Phase.
Tidsramme: 52 weeks
Time to first severe SLE flare is defined as the number of days from first treatment until the participant had an event (event date-treatement start date +1). If a participant had a severe SFI flare and received protocol restricted medication then the event date was the earliest of the first severe SFI flare date, and the treatment failure date. Analysis of severe SFI flare was performed on the modified SELENA SLEDAI SLE flare index in which the modification excluded severe flares that were triggered only by an increase in SELENA SLEDAI score to >12. Analysis was from Cox proportional hazards model for the comparison between belimumab and placebo adjusting for country, Baseline SELENA SLEDAI score (<=9 vs. >=10) and complement levels (low C3 and/or C4 vs. no low C3 or C4).
52 weeks
Percent of Participants Achieving SLE SRI Response Rate for Open-label (OL) Phase
Tidsramme: Weeks 24 and 48 for Years 2, 3, 4, 5 and 6
SRI response is a composite index, defined as the percent of participants with >=4 point reduction from Baseline in SELENA SLEDAI score and no worsening (increase of < 0.30 points from Baseline) in PGA and no new BILAG A organ domain score or 2 new BILAG B organ domain scores compared with Baseline at time of assessment. Excludes participants with a SELENA SLEDAI score <4 at baseline. Participants randomized to belimumab in double-blinded (DB) phase, Baseline is last available value before first belimumab dose received in DB phase. Participants randomized to placebo in DB phase, Baseline is last available value before receiving first belimumab dose in OL phase. Observed case data are presented.Year 6 Week 48 is the Exit Visit obtained by slotting the Exit Visit to Week 48. A SELENA SLEDAI score of 0 (no lupus activity) and a score of 105 (maximum). PGA ranges from 0 (no activity) to 3 (severe activity). BILAG has no range.
Weeks 24 and 48 for Years 2, 3, 4, 5 and 6

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

GlaxoSmithKline

Samarbeidspartnere

Human Genome Sciences Inc.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

23. mai 2011

Primær fullføring (Faktiske)

15. september 2015

Studiet fullført (Faktiske)

21. september 2018

Datoer for studieregistrering

Først innsendt

28. april 2011

Først innsendt som oppfylte QC-kriteriene

28. april 2011

Først lagt ut (Anslag)

2. mai 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. oktober 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. september 2019

Sist bekreftet

1. september 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 113750

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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