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A Study of Belimumab Administered Subcutaneously in Subjects With Systemic Lupus Erythematosus (SLE) (BLISS-SC)

31 maggio 2018 aggiornato da: Human Genome Sciences Inc., a GSK Company

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects With Systemic Lupus Erythematosus (SLE)

The purpose of this study is to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) to adult subjects with Systemic Lupus Erythematosus (SLE).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a Phase 3, multi-center, international, randomized, double-blind, placebo-controlled, 52-week study to evaluate the efficacy, safety and tolerability of belimumab administered subcutaneously (SC) (200 mg weekly) in adult subjects with active Systemic Lupus Erythematosus (SLE). Approximately 816 SLE subjects will be randomized, with a target of about 544 subjects receiving belimumab and 272 subjects receiving placebo. Subjects completing the 52-week double-blind period can enter a 6-month open-label extension in which all subjects receive belimumab 200 mg SC weekly.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

839

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

  • Argentina
      • Ciudad Autonoma Buenos Aires, Argentina, C1015ABO
        • GSK Investigational Site
      • Ciudad Autonoma Buenos Aires, Argentina, C1426AAL
        • GSK Investigational Site
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1419AHN
        • GSK Investigational Site
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1181ACI
        • GSK Investigational Site
      • La Plata, Buenos Aires, Argentina, B1902COS
        • GSK Investigational Site
  • Austria
      • Vienna, Austria, A-1100
        • GSK Investigational Site
  • Belgio
      • Brussels, Belgio, 1090
        • GSK Investigational Site
      • Bruxelles, Belgio, 1200
        • GSK Investigational Site
      • Liège, Belgio, 4000
        • GSK Investigational Site
  • Brasile
      • Rio de Janeiro, Brasile, 21941-913
        • GSK Investigational Site
      • Salvador, Brasile, 40050-410
        • GSK Investigational Site
      • São Paulo, Brasile, 04032-060
        • GSK Investigational Site
    • Mato Grosso
      • Cuiaba, Mato Grosso, Brasile, 78005-000
        • GSK Investigational Site
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brasile, 36038-330
        • GSK Investigational Site
    • Paraná
      • Curitiba, Paraná, Brasile, 80440-080
        • GSK Investigational Site
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brasile, 90035-903
        • GSK Investigational Site
      • Porto Alegre, Rio Grande Do Sul, Brasile, 90110-270
        • GSK Investigational Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • GSK Investigational Site
      • Ruse, Bulgaria, 7002
        • GSK Investigational Site
      • Sofia, Bulgaria, 1784
        • GSK Investigational Site
  • Cechia
      • Praha 2, Cechia, 128 50
        • GSK Investigational Site
      • Zlin, Cechia, 760 01
        • GSK Investigational Site
  • Chile
      • Santiago, Chile, 7500000
        • GSK Investigational Site
      • Viña del Mar, Chile, 2570017
        • GSK Investigational Site
    • Región Metro De Santiago
      • Santiago, Región Metro De Santiago, Chile, 7501126
        • GSK Investigational Site
  • Colombia
      • Barranquilla, Colombia
        • GSK Investigational Site
      • Bogota, Colombia
        • GSK Investigational Site
      • Bucaramanga, Colombia
        • GSK Investigational Site
      • Medellin, Colombia
        • GSK Investigational Site
  • Croazia
      • Osijek, Croazia, 31000
        • GSK Investigational Site
      • Rijeka, Croazia, 51000
        • GSK Investigational Site
      • Zagreb, Croazia, 10000
        • GSK Investigational Site
  • Danimarca
      • Koebenhavn, Danimarca, 2100
        • GSK Investigational Site
      • Odense C, Danimarca, 5000
        • GSK Investigational Site
  • Federazione Russa
      • Moscow, Federazione Russa, 115522
        • GSK Investigational Site
      • Saint-Petersburg, Federazione Russa, 190068
        • GSK Investigational Site
      • Yaroslavl, Federazione Russa, 150030
        • GSK Investigational Site
  • Filippine
      • Cebu City, Filippine, 6000
        • GSK Investigational Site
      • Davao City, Filippine, 8000
        • GSK Investigational Site
      • Iloilo City, Filippine, 5000
        • GSK Investigational Site
      • Las Pinas, Filippine, 1740
        • GSK Investigational Site
      • Manila, Filippine, 1000
        • GSK Investigational Site
      • Manila, Filippine, 1015
        • GSK Investigational Site
      • Quezon City, Filippine, 1102
        • GSK Investigational Site
      • Quezon City, Filippine, 1118
        • GSK Investigational Site
  • Francia
      • Paris, Francia, 75679
        • GSK Investigational Site
      • Paris cedex 13, Francia, 75651
        • GSK Investigational Site
      • Pessac Cedex, Francia, 33604
        • GSK Investigational Site
      • Strasbourg cedex, Francia, 67091
        • GSK Investigational Site
      • Suresnes, Francia, 92150
        • GSK Investigational Site
      • Vandoeuvre les Nancy, Francia, 54511
        • GSK Investigational Site
  • Germania
      • Frankfurt, Germania, 60590
        • GSK Investigational Site
      • Hamburg, Germania, 22081
        • GSK Investigational Site
    • Bayern
      • Wuerzburg, Bayern, Germania, 97080
        • GSK Investigational Site
    • Hessen
      • Bad Nauheim, Hessen, Germania, 61231
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Germania, 30625
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Duesseldorf, Nordrhein-Westfalen, Germania, 40225
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germania, 55131
        • GSK Investigational Site
  • Giappone
      • Fukuoka, Giappone, 807-8555
        • GSK Investigational Site
      • Fukuoka, Giappone, 810-8563
        • GSK Investigational Site
      • Hokkaido, Giappone, 060-8648
        • GSK Investigational Site
      • Hokkaido, Giappone, 060-8604
        • GSK Investigational Site
      • Miyagi, Giappone, 980-8574
        • GSK Investigational Site
      • Nagasaki, Giappone, 857-1195
        • GSK Investigational Site
      • Okinawa, Giappone, 901-0243
        • GSK Investigational Site
      • Shizuoka, Giappone, 430-8558
        • GSK Investigational Site
      • Tokyo, Giappone, 160-8582
        • GSK Investigational Site
      • Tokyo, Giappone, 162-8655
        • GSK Investigational Site
      • Tokyo, Giappone, 104-8560
        • GSK Investigational Site
  • Italia
      • Genova, Italia, 16132
        • GSK Investigational Site
    • Toscana
      • Pisa, Toscana, Italia, 56126
        • GSK Investigational Site
    • Veneto
      • Padova, Veneto, Italia, 35128
        • GSK Investigational Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • GSK Investigational Site
      • Seremban, Negeri Sembilan, Malaysia, 70300
        • GSK Investigational Site
  • Messico
      • Mexico, Messico, 06700
        • GSK Investigational Site
      • Mexico, Messico, 3100
        • GSK Investigational Site
      • San Luis Potosi, Messico, 78240
        • GSK Investigational Site
    • Jalisco
      • Guadalajara, Jalisco, Messico, 44158
        • GSK Investigational Site
      • Guadalajara, Jalisco, Messico, 44690
        • GSK Investigational Site
    • Morelos
      • Cuernavaca, Morelos, Messico, 62270
        • GSK Investigational Site
    • Yucatán
      • Merida, Yucatán, Messico, 97130
        • GSK Investigational Site
  • Polonia
      • Bydgoszcz, Polonia, 85-168
        • GSK Investigational Site
      • Katowice, Polonia, 40-635
        • GSK Investigational Site
      • Krakow, Polonia, 31-066
        • GSK Investigational Site
      • Wroclaw, Polonia, 50-556
        • GSK Investigational Site
  • Portogallo
      • Almada, Portogallo, 2801-915
        • GSK Investigational Site
      • Amadora, Portogallo, 2720-276
        • GSK Investigational Site
      • Coimbra, Portogallo, 3000-075
        • GSK Investigational Site
      • Lisboa, Portogallo, 1649-035
        • GSK Investigational Site
      • Porto, Portogallo, 4099-001
        • GSK Investigational Site
  • Regno Unito
      • Birmingham, Regno Unito, B15 2TH
        • GSK Investigational Site
      • London, Regno Unito, SE1 7EH
        • GSK Investigational Site
    • Warwickshire
      • Coventry, Warwickshire, Regno Unito, CV2 2DX
        • GSK Investigational Site
  • Romania
      • Bucharest, Romania, 020125
        • GSK Investigational Site
      • Bucharest, Romania, 11172
        • GSK Investigational Site
      • Bucuresti, Romania, 020475
        • GSK Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • GSK Investigational Site
      • Belgrade, Serbia, 11080
        • GSK Investigational Site
  • Singapore
      • Singapore, Singapore, 529889
        • GSK Investigational Site
  • Spagna
      • Barcelona, Spagna, 08036
        • GSK Investigational Site
      • Barcelona, Spagna, 8035
        • GSK Investigational Site
      • Granada, Spagna, 18012
        • GSK Investigational Site
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35294
        • GSK Investigational Site
    • Arizona
      • Peoria, Arizona, Stati Uniti, 85381
        • GSK Investigational Site
      • Tucson, Arizona, Stati Uniti, 85712
        • GSK Investigational Site
      • Tucson, Arizona, Stati Uniti, 85724
        • GSK Investigational Site
    • Arkansas
      • Jonesboro, Arkansas, Stati Uniti, 72401
        • GSK Investigational Site
    • California
      • La Jolla, California, Stati Uniti, 92037-0943
        • GSK Investigational Site
      • Long Beach, California, Stati Uniti, 90806
        • GSK Investigational Site
      • Los Angeles, California, Stati Uniti, 90033
        • GSK Investigational Site
      • San Diego, California, Stati Uniti, 92120
        • GSK Investigational Site
      • San Francisco, California, Stati Uniti, 94118
        • GSK Investigational Site
      • San Jose, California, Stati Uniti, 95126-1650
        • GSK Investigational Site
      • San Leandro, California, Stati Uniti, 94578
        • GSK Investigational Site
      • Tustin, California, Stati Uniti, 92780
        • GSK Investigational Site
      • Upland, California, Stati Uniti, 91786
        • GSK Investigational Site
    • Connecticut
      • Bridgeport, Connecticut, Stati Uniti, 06606
        • GSK Investigational Site
    • Florida
      • Aventura, Florida, Stati Uniti, 33180
        • GSK Investigational Site
      • Boca Raton, Florida, Stati Uniti, 33486
        • GSK Investigational Site
      • Boca Raton, Florida, Stati Uniti, 33432
        • GSK Investigational Site
      • Coral Gables, Florida, Stati Uniti, 33134
        • GSK Investigational Site
      • Fort Lauderdale, Florida, Stati Uniti, 33334
        • GSK Investigational Site
      • Miami, Florida, Stati Uniti, 33136
        • GSK Investigational Site
      • Orlando, Florida, Stati Uniti, 32804
        • GSK Investigational Site
      • Orlando, Florida, Stati Uniti, 32806-6264
        • GSK Investigational Site
      • Plantation, Florida, Stati Uniti, 33324
        • GSK Investigational Site
      • Tampa, Florida, Stati Uniti, 33614
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30342
        • GSK Investigational Site
      • Atlanta, Georgia, Stati Uniti, 30303
        • GSK Investigational Site
      • Duluth, Georgia, Stati Uniti, 30096
        • GSK Investigational Site
      • Lawrenceville, Georgia, Stati Uniti, 30045
        • GSK Investigational Site
      • Marietta, Georgia, Stati Uniti, 30060
        • GSK Investigational Site
    • Idaho
      • Boise, Idaho, Stati Uniti, 83704
        • GSK Investigational Site
    • Illinois
      • Springfield, Illinois, Stati Uniti, 62704
        • GSK Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, Stati Uniti, 70809
        • GSK Investigational Site
      • New Orleans, Louisiana, Stati Uniti, 70121
        • GSK Investigational Site
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21205
        • GSK Investigational Site
      • Cumberland, Maryland, Stati Uniti, 21502
        • GSK Investigational Site
      • Hagerstown, Maryland, Stati Uniti, 21740
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02118
        • GSK Investigational Site
      • Boston, Massachusetts, Stati Uniti, 02115
        • GSK Investigational Site
    • Michigan
      • Detroit, Michigan, Stati Uniti, 48202
        • GSK Investigational Site
      • Saint Clair Shores, Michigan, Stati Uniti, 48081
        • GSK Investigational Site
    • Mississippi
      • Jackson, Mississippi, Stati Uniti, 39202
        • GSK Investigational Site
    • Missouri
      • Saint Louis, Missouri, Stati Uniti, 63110
        • GSK Investigational Site
    • New Mexico
      • Las Cruces, New Mexico, Stati Uniti, 88011
        • GSK Investigational Site
    • New York
      • Brooklyn, New York, Stati Uniti, 11203
        • GSK Investigational Site
      • Lake Success, New York, Stati Uniti, 11042
        • GSK Investigational Site
      • Manhasset, New York, Stati Uniti, 11030
        • GSK Investigational Site
      • New York, New York, Stati Uniti, 10016
        • GSK Investigational Site
      • Smithtown, New York, Stati Uniti, 11787
        • GSK Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27599-7280
        • GSK Investigational Site
      • Charlotte, North Carolina, Stati Uniti, 28207
        • GSK Investigational Site
      • Charlotte, North Carolina, Stati Uniti, 28210
        • GSK Investigational Site
      • Durham, North Carolina, Stati Uniti, 27710
        • GSK Investigational Site
      • Greenville, North Carolina, Stati Uniti, 27834
        • GSK Investigational Site
    • Ohio
      • Cleveland, Ohio, Stati Uniti, 44109
        • GSK Investigational Site
      • Columbus, Ohio, Stati Uniti, 43203
        • GSK Investigational Site
      • Dayton, Ohio, Stati Uniti, 45417
        • GSK Investigational Site
      • Toledo, Ohio, Stati Uniti, 43614
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73103
        • GSK Investigational Site
      • Tulsa, Oklahoma, Stati Uniti, 74104
        • GSK Investigational Site
    • Pennsylvania
      • Bethlehem, Pennsylvania, Stati Uniti, 18015
        • GSK Investigational Site
      • Duncansville, Pennsylvania, Stati Uniti, 16635
        • GSK Investigational Site
      • Wyomissing, Pennsylvania, Stati Uniti, 19610
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29425
        • GSK Investigational Site
      • Charleston, South Carolina, Stati Uniti, 29406
        • GSK Investigational Site
      • Greenville, South Carolina, Stati Uniti, 29601
        • GSK Investigational Site
      • Orangeburg, South Carolina, Stati Uniti, 29118
        • GSK Investigational Site
    • Tennessee
      • Jackson, Tennessee, Stati Uniti, 38305
        • GSK Investigational Site
      • Memphis, Tennessee, Stati Uniti, 38119
        • GSK Investigational Site
    • Texas
      • Allentown, Texas, Stati Uniti, 75013
        • GSK Investigational Site
      • Austin, Texas, Stati Uniti, 78705
        • GSK Investigational Site
      • Austin, Texas, Stati Uniti, 78758
        • GSK Investigational Site
      • Dallas, Texas, Stati Uniti, 75231
        • GSK Investigational Site
      • Houston, Texas, Stati Uniti, 77074
        • GSK Investigational Site
      • Houston, Texas, Stati Uniti, 77004
        • GSK Investigational Site
      • Houston, Texas, Stati Uniti, 77008
        • GSK Investigational Site
      • Houston, Texas, Stati Uniti, 77034
        • GSK Investigational Site
      • Nassau Bay, Texas, Stati Uniti, 77058
        • GSK Investigational Site
    • Virginia
      • Arlington, Virginia, Stati Uniti, 22205-3606
        • GSK Investigational Site
    • Washington
      • Seattle, Washington, Stati Uniti, 98133
        • GSK Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, Stati Uniti, 53226
        • GSK Investigational Site
    • Wyoming
      • Pennsylvania, Wyoming, Stati Uniti, 19610
        • GSK Investigational Site
  • Svezia
      • Göteborg, Svezia, SE-413 45
        • GSK Investigational Site
      • Lund, Svezia, SE-221 85
        • GSK Investigational Site
      • Stockholm, Svezia, SE-171 76
        • GSK Investigational Site
  • Tailandia
      • Bangkok, Tailandia, 10400
        • GSK Investigational Site
      • Bangkok, Tailandia, 10700
        • GSK Investigational Site
      • Chiangmai, Tailandia, 50200
        • GSK Investigational Site
      • Rajathevee, Tailandia, 10400
        • GSK Investigational Site
      • Ratchatewi, Tailandia, 10400
        • GSK Investigational Site
      • Songkla, Tailandia, 90110
        • GSK Investigational Site
  • Taiwan
      • Gueishan Township,Taoyuan County, Taiwan, 333
        • GSK Investigational Site
      • Kaohsiung, Taiwan, 833
        • GSK Investigational Site
      • Kaohsiung, Taiwan, 813
        • GSK Investigational Site
      • Kaohsiung, Taiwan, 807
        • GSK Investigational Site
      • Taichung, Taiwan, 404
        • GSK Investigational Site
      • Taipei, Taiwan, 100
        • GSK Investigational Site
  • Ucraina
      • Kharkiv, Ucraina, 61039
        • GSK Investigational Site
      • Kyiv, Ucraina, 01601
        • GSK Investigational Site
      • Odesa, Ucraina, 65026
        • GSK Investigational Site
      • Poltava, Ucraina, 36011
        • GSK Investigational Site
      • Vinnytsia, Ucraina, 21018
        • GSK Investigational Site
      • Zaporizhzhia, Ucraina, 69600
        • GSK Investigational Site
  • Ungheria
      • Debrecen, Ungheria, 4032
        • GSK Investigational Site
      • Zalaegerszeg, Ungheria, 8900
        • 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:

  1. At least 18 years of age.
  2. Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria.
  3. Active SLE disease.
  4. Autoantibody-positive.
  5. On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate, etc.)

Exclusion Criteria:

  1. Pregnant or nursing.
  2. Have received treatment with any B cell targeted therapy (for example, rituximab or belimumab).
  3. Have received treatment an investigational biological agent in the past year.
  4. Have received intravenous (IV) cyclophosphamide within 90 days of Day 0.
  5. Have severe active lupus kidney disease.
  6. Have severe active central nervous system (CNS) lupus.
  7. Have required management of acute or chronic infections within the past 60 days.
  8. Have current drug or alcohol abuse or dependence.
  9. Have a positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
  10. Have a history of hypersensitivity reactions to contrast agents or biological medicines.

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: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo plus standard therapy
Placebo SC plus standard therapy; placebo administered on Day 0 and then weekly (ie, every 7 days) through Week 51, with final evaluation at Week 52 in the double-blind period. In the open-label extension period, placebo subjects who opt to participate will receive belimumab 200 mg SC weekly for an additional 6-months.
Biologico: Placebo
Placebo
Droga: Terapia standard
La terapia standard comprende uno qualsiasi dei seguenti (da soli o in combinazione): corticosteroidi, antimalarici, farmaci antinfiammatori non steroidei (FANS) e immunosoppressori; i farmaci biologici e la ciclofosfamide per via endovenosa non sono consentiti.
Sperimentale: Belimumab 200 mg SC plus standard therapy
Belimumab 200 mg SC plus standard therapy; belimumab administered on Day 0 and then weekly (ie, every 7 days) through Week 51, with a final evaluation at Week 52 in the double-blind period. In the open-label extension period, subjects who opt to participate will continue on the same dose of belimumab for an additional 6-months.
Droga: Terapia standard
La terapia standard comprende uno qualsiasi dei seguenti (da soli o in combinazione): corticosteroidi, antimalarici, farmaci antinfiammatori non steroidei (FANS) e immunosoppressori; i farmaci biologici e la ciclofosfamide per via endovenosa non sono consentiti.
Biologico: Belimumab 200 mg SC
Belimumab 200 mg SC
Altri nomi:
  • BENLYSTA™

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52
Lasso di tempo: Week 52
SRI response is defined as >=4 point reduction, from Baseline in safety of estrogen in lupus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) score, no worsening (increase of <0.30 points from Baseline) in physician's global assessment (PGA) and no new British Isles Lupus Assessment Group of SLE clinics (BILAG) A organ domain score or 2 new BILAG B organ domain scores compared with Baseline. Analysis was performed using a logistic regression model for the comparison between belimumab and placebo with covariates treatment group, Baseline SELENA SLEDAI score (<=9 vs. >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).
Week 52

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to First Severe Flare (as Measured by the Modified SLE Flare Index)
Lasso di tempo: Baseline (Day 0, prior to dosing) to Week 52
Time to first severe SLE flare is defined as the number of days from treatment start date until the participant met an event (event date - treatment start date +1). Analyses of severe SLE flare was performed on modified SELENA SLEDAI SLE flare index that excludes severe flares that were triggered only by an increase in SELENA SLEDAI score to >12 (since this may only represent a modest increase in disease activity). Only post-baseline severe flares were considered.
Baseline (Day 0, prior to dosing) to Week 52
Percentage of Par. Whose Average Prednisone Dose Had Been Reduced by >=25% From Baseline to <=7.5 mg/Day During Weeks 40 Through 52 in Par. Receiving Greater Than 7.5 mg/Day at Baseline
Lasso di tempo: Baseline (Day 0, prior to dosing), Weeks 40 through Week 52
For the analysis of steroid use, all steroid dosages were converted to a prednisone equivalent in mg. The average daily prednisone dose was calculated taking into account all steroids taken intravenously, intramuscularly, SC, intradermally and orally for both SLE and non-SLE reasons. A responder was defined as having a prednisone reduction by >=25% from Baseline to <=7.5 mg/day during Weeks 40 through 52. At Baseline, the average daily prednisone dose was the sum of all prednisone doses over 7 consecutive days up to, but not including Day 0, divided by 7. For this analysis, the average prednisone dose was the total prednisone dose during weeks 40 through 52 divided by the number of days during Weeks 40 through 52. Analysis was performed using a logistic regression model with covariates treatment group, Baseline prednisone dose, Baseline SELENA SLEDAI score, (<=9 vs >=10), Baseline complement levels (low C3 and/or C4 vs. no low C3 or C4) and race (black vs. other).
Baseline (Day 0, prior to dosing), Weeks 40 through Week 52

Collaboratori e investigatori

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

Sponsor

Human Genome Sciences Inc., a GSK Company

Collaboratori

GlaxoSmithKline

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

Collegamenti utili

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

16 novembre 2011

Completamento primario (Effettivo)

13 febbraio 2015

Completamento dello studio (Effettivo)

1 ottobre 2015

Date di iscrizione allo studio

Primo inviato

28 novembre 2011

Primo inviato che soddisfa i criteri di controllo qualità

30 novembre 2011

Primo Inserito (Stima)

2 dicembre 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 giugno 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

31 maggio 2018

Ultimo verificato

1 maggio 2018

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 112341
  • 2011-003814-18
  • HGS1006-C1115

Piano per i dati dei singoli partecipanti (IPD)

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Descrizione del piano IPD

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Dati/documenti di studio

  1. Modulo di consenso informato
    Identificatore informazioni: 112341
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  2. Specifica del set di dati
    Identificatore informazioni: 112341
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  3. Rapporto di studio clinico
    Identificatore informazioni: 112341
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  4. Set di dati del singolo partecipante
    Identificatore informazioni: 112341
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  5. Piano di analisi statistica
    Identificatore informazioni: 112341
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  6. Modulo di segnalazione del caso annotato
    Identificatore informazioni: 112341
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  7. Protocollo di studio
    Identificatore informazioni: 112341
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register

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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