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

31. maj 2018 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

839

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

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

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:

  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.

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: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: 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.
Biologisk: Placebo
Placebo
Medicin: Standard terapi
Standardterapi omfatter en hvilken som helst af følgende (alene eller i kombination): kortikosteroider, antimalariamidler, ikke-steroide antiinflammatoriske lægemidler (NSAID'er) og immunsuppressiva; biologiske lægemidler og intravenøs cyclophosphamid er ikke tilladt.
Eksperimentel: 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.
Medicin: Standard terapi
Standardterapi omfatter en hvilken som helst af følgende (alene eller i kombination): kortikosteroider, antimalariamidler, ikke-steroide antiinflammatoriske lægemidler (NSAID'er) og immunsuppressiva; biologiske lægemidler og intravenøs cyclophosphamid er ikke tilladt.
Biologisk: Belimumab 200 mg SC
Belimumab 200 mg SC
Andre navne:
  • BENLYSTA™

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Par. Achieving a SLE Responder Index (SRI) Response Rate at Week 52
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to First Severe Flare (as Measured by the Modified SLE Flare Index)
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

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

Sponsor

Human Genome Sciences Inc., a GSK Company

Samarbejdspartnere

GlaxoSmithKline

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

Hjælpsomme links

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

16. november 2011

Primær færdiggørelse (Faktiske)

13. februar 2015

Studieafslutning (Faktiske)

1. oktober 2015

Datoer for studieregistrering

Først indsendt

28. november 2011

Først indsendt, der opfyldte QC-kriterier

30. november 2011

Først opslået (Skøn)

2. december 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juni 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

31. maj 2018

Sidst verificeret

1. maj 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

Studiedata/dokumenter

  1. Formular til informeret samtykke
    Informations-id: 112341
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Datasætspecifikation
    Informations-id: 112341
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Klinisk undersøgelsesrapport
    Informations-id: 112341
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Individuelt deltagerdatasæt
    Informations-id: 112341
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Statistisk analyseplan
    Informations-id: 112341
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Annoteret sagsbetænkningsformular
    Informations-id: 112341
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Studieprotokol
    Informations-id: 112341
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

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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