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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 settembre 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

709

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
placebo
Droga: 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.
Sperimentale: Belimumab
10mg/kg
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percent of Participants Achieving Systemic Lupus Erythematosus (SLE) Responder Index (SRI) Response Rate at Week 52 for Double-blind Phase.
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percent of Participants With >=4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52 for Double-blind Phase.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

GlaxoSmithKline

Collaboratori

Human Genome Sciences Inc.

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

23 maggio 2011

Completamento primario (Effettivo)

15 settembre 2015

Completamento dello studio (Effettivo)

21 settembre 2018

Date di iscrizione allo studio

Primo inviato

28 aprile 2011

Primo inviato che soddisfa i criteri di controllo qualità

28 aprile 2011

Primo Inserito (Stima)

2 maggio 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 ottobre 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 settembre 2019

Ultimo verificato

1 settembre 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 113750

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Sponsor e collaboratori

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Condizioni

Malattie rare

Interventi farmacologici

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Sedi

3
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