A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
GlaxoSmithKline
Study ID
NCT03312907
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belimumab — DRUG
    Belimumab will be administered as SC injection once weekly via autoinjector in thigh or abdomen
  • Rituximab — DRUG
    Rituximab will be administered as IV infusion of 1000mg at Week 4 and Week 6
  • Rituximab-placebo — DRUG
    Saline will be administered as IV infusions at Week 4 and Week 6
  • Standard therapy (Including Immunosuppressants) — DRUG
    Standard therapy will contain stable SLE medications including immunosuppressant to be administered from baseline through Week 104.
  • Standard therapy (Excluding Immunosuppressants) — DRUG
    Standard therapy excluding Immunosuppressant will contain anti-malarials, NSAIDs, and/or corticosteroids with prednisone dose equivalent to \<= 5 mg/day will administered through Week 104.
  • Steroid Taper — DRUG
    Steroid taper will include prednisone doses equivalent to =\< 5 mg/day in all Arms through Week 104.

Study Details

The purpose of this study is to assess whether co-administration of belimumab and a single cycle of rituximab will optimize treatment with belimumab, which will result in improvements of clinical status with a favorable safety profile, by comparing subjects randomized to belimumab plus rituximab versus belimumab plus rituximab-placebo. Approximately 292 subjects will be randomized in a 1:2:1 ratio to 1 of 3 treatment arms; belimumab plus rituximab-placebo (Arm A, control), belimumab plus rituximab (Arm B, combination), or belimumab plus standard therapy (Arm C, reference). Belimumab will be administered as subcutaneous (SC) and rituximab-placebo or rituximab will be administered by intravenous (IV) infusions. The total duration of the study is for 104 weeks.

Key Dates

Start date
Mar 1, 2018
Status verified
Jan 2025
Primary completion
May 29, 2020
Completion
Jul 7, 2021

Study Design

Enrollment
292 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Belimumab + Placebo
    Eligible subjects will receive Belimumab 200 milligrams (mg) to be administered subcutaneously (SC) on Day 1 and then weekly (i.e., every 7 days) through Week 52. Subjects will also receive rituximab-placebo to be administered by intravenous (IV) infusions at Weeks 4 and 6 in double blind manner. Subjects will receive standard therapy excluding Immunosuppressants and including anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), and/or corticosteroids tapered down to prednisone equivalent of less than or equal to (\<=) 5 mg/day until Week 104. Subjects will not receive treatment after 52 weeks and will be in observation until Week 104.
  • Experimental: Belimumab + Rituximab
    Eligible subjects will receive Belimumab 200 mg to be administered SC on Day 1 and then weekly (i.e., every 7 days) through Week 52. Subjects will also receive rituximab 1000 mg to be administered by IV infusions at Weeks 4 and 6 in double blind manner. Subjects will receive standard therapy excluding Immunosuppressants and including anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104. Subjects will not receive treatment after 52 weeks and will be in observation until Week 104.
  • Other: Belimumab + Standard therapy
    Eligible subjects will receive open-label Belimumab 200 mg administered SC on Day 1 and then weekly (i.e., every 7 days) until Week 104. Subjects will also receive standard therapy including immunosuppressant, anti-malarials, NSAIDs, and/or corticosteroids tapered down to prednisone equivalent of \<= 5 mg/day until Week 104.

Primary Outcome Measure

Percentage of Participants With a State of Disease Control at Week 52 [ Time Frame: Week 52 ]

Locations (28)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteBirminghamAlabama35294-
GSK Investigational SiteLa MesaCalifornia92020-
GSK Investigational SiteSan LeandroCalifornia94578-
GSK Investigational SiteUplandCalifornia91786-
GSK Investigational SiteDenverColorado80230-
GSK Investigational SiteAventuraFlorida33180-
GSK Investigational SiteMiamiFlorida33136-
GSK Investigational SiteOrlandoFlorida32806-6264-
GSK Investigational SiteTamaracFlorida33321-
GSK Investigational SiteTampaFlorida33613-
GSK Investigational SiteTampaFlorida33614-
GSK Investigational SiteAnn ArborMichigan48109-5542-
GSK Investigational SiteBrightonMichigan48116-
GSK Investigational SiteLansingMichigan48910-
GSK Investigational SiteLansingMichigan48917-
GSK Investigational SiteLas CrucesNew Mexico88011-
GSK Investigational SiteManhassetNew York11030-
GSK Investigational SiteNew YorkNew York10016-
GSK Investigational SiteNew YorkNew York10032-
GSK Investigational SiteCharlotteNorth Carolina28204-
GSK Investigational SiteVandaliaOhio45377-
GSK Investigational SiteOklahoma CityOklahoma73102-
GSK Investigational SitePittsburghPennsylvania15224-
GSK Investigational SiteSummervilleSouth Carolina29486-
GSK Investigational SiteAustinTexas78731-
GSK Investigational SiteLeague CityTexas77573-
GSK Investigational SiteSpokaneWashington99204-
GSK Investigational SiteGlendaleWisconsin53217-

Find similar trials in Birmingham, AL

By condition
Lupus (SLE)
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GSK Investigational Site· Birmingham, ALGSK Investigational Site· La Mesa, CAGSK Investigational Site· San Leandro, CAGSK Investigational Site· Upland, CAGSK Investigational Site· Denver, COGSK Investigational Site· Aventura, FL

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