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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 września 2019 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

709

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Placebo
placebo
Lek: 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.
Eksperymentalny: Belimumab
10 mg/kg mc
Lek: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52 for Double-blind Phase.
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Percent of Participants With >=4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52 for Double-blind Phase.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

GlaxoSmithKline

Współpracownicy

Human Genome Sciences Inc.

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

23 maja 2011

Zakończenie podstawowe (Rzeczywisty)

15 września 2015

Ukończenie studiów (Rzeczywisty)

21 września 2018

Daty rejestracji na studia

Pierwszy przesłany

28 kwietnia 2011

Pierwszy przesłany, który spełnia kryteria kontroli jakości

28 kwietnia 2011

Pierwszy wysłany (Oszacować)

2 maja 2011

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 października 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

20 września 2019

Ostatnia weryfikacja

1 września 2019

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 113750

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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