A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT03616912
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Baricitinib — DRUG
    Administered orally.
  • Placebo — DRUG
    Administered orally.

Study Details

The reason for this study is to see how effective and safe the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE).

Key Dates

Start date
Aug 2, 2018
Status verified
Jan 2023
Primary completion
Nov 1, 2021
Completion
Mar 9, 2022

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Participants received two placebo tablets: one matching baricitinib 4 milligram (mg) and one matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.
  • Experimental: 2 mg Baricitinib
    Participants received one Baricitinib 2 mg tablet and one placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
  • Experimental: 4 mg Baricitinib
    Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.
  • Placebo Comparator: Placebo Maximum Extended Enrollment (MEE)
    Participants received two placebo tablets: one matching baricitinib 4 mg and one matching baricitinib 2 mg administered orally QD for 52 weeks.
  • Experimental: 2 mg Baricitinib (MEE)
    Participants received one Baricitinib 2 mg tablet and 1 placebo tablet matching Baricitinib 4 mg administered QD for 52 weeks.
  • Experimental: 4 mg Baricitinib (MEE)
    Participants received one Baricitinib 4 mg tablet and one placebo tablet matching baricitinib 2 mg administered orally every day (QD) for 52 weeks.

Primary Outcome Measure

Percentage of Participants Achieving a Systemic Lupus Erythematosus Responder Index 4 (SRI-4) Response (4 mg Baricitinib) [ Time Frame: Week 52 ]

Locations (60)

FacilityCityStateZIPSite coordinators
Achieve Clinical Research, LLCBirminghamAlabama35216-
University of Alabama at BirminghamBirminghamAlabama35294-
Arizona Arthritis & Rheumatology Research, PLLCGlendaleArizona85306-
University of ArizonaTucsonArizona85711-
St. Joseph Heritage Medical GroupFullertonCalifornia92835-
MD Medical CorporationHemetCalifornia92543-
ACRC StudiesPowayCalifornia92064-
Office: Hans R Barthel M.D.Santa BarbaraCalifornia93108-
Medvin Clinical Research - WeidmannWhittierCalifornia90602-
Denver Arthritis Clinic - LowryDenverColorado80230-
New England Research AssociatesBridgeportConnecticut06606-
Yale University School of MedicineNew HavenConnecticut06519-
Arthritis and Rheumatic DiseaseAventuraFlorida33180-
Rheumatology Associates of South FloridaBoca RatonFlorida33486-
Clinical Research of West Florida, Inc. (Clearwater)ClearwaterFlorida33765-
Arthritis and Rheumatology Center of South FloridaMargateFlorida33063-
Lakes Research, LLCMiami LakesFlorida33014-
Millennium ResearchOrmond BeachFlorida32174-
IRIS Research and Development, LLCPlantationFlorida33324-
ForCare Clinical ResearchTampaFlorida33613-1244-
Atlanta Center for Clinical ResearchAtlantaGeorgia30342-
Piedmont HealthcareAtlantaGeorgia30318-
St Luke's Clinic - Intermountain OrthopaedicsBoiseIdaho83702-
Rockford Orthopedic AssociatesRockfordIllinois61114-
Henry Ford Health SystemDetroitMichigan48202-
Clinical Research Institute of Michigan, LLCSaint Clair ShoresMichigan48081-
St. Louis RheumatologySt LouisMissouri63119-
Glacier View Research Institute - EndocrinologyKalispellMontana59901-
Allied Clinical ResearchRenoNevada89519-
Albuquerque Center for RheumatologyAlbuquerqueNew Mexico87102-
SUNY Health Science CenterBrooklynNew York11203-
St. Lawrence Health SystemCantonNew York13617-
Northwell HealthGreat NeckNew York11021-
The Feinstein Institute for Medical ResearchManhassetNew York11030-
Columbia University Medical CenterNew YorkNew York10032-
Buffalo RheumatologyOrchard ParkNew York14127-
Joint and Muscle Medical CareCharlotteNorth Carolina28204-
Medication Management, LLCGreensboroNorth Carolina27408-
PMG Research of WilmingtonWilmingtonNorth Carolina28401-
Cincinnati Arthritis AssociatesCincinnatiOhio45242-
The Ohio State UniversityColumbusOhio43210-
Paramount Medical ResearchMiddleburg HeightsOhio44130-
Arthritis & Rheumatology Center of Oklahoma PLLCOklahoma CityOklahoma73102-
East Penn Rheumatology AssociatesBethlehemPennsylvania18015-
UPMC Lupus Center of ExcellencePittsburghPennsylvania15213-
West Tennessee Research InstituteJacksonTennessee38305-
Amarillo Center for Clinical ResearchAmarilloTexas79124-
Accurate Clinical ManagementBaytownTexas77521-
Dr. Dhiman Basu Private PracticeColleyvilleTexas76034-
Metroplex Clinical Research CenterDallasTexas75231-
Precision Comprehensive Clinical Research SolutionsFort WorthTexas76107-
Accurate Clinical ResearchHoustonTexas77089-
Rheumatology Center of HoustonHoustonTexas77004-
Southwest Rheumatology, P.A.MesquiteTexas75150-
Accurate Clinical Research, Inc.San AntonioTexas78229-
Univ of Texas Health Science Center at San AntonioSan AntonioTexas78229-
Arthritis Clinic Of Central TexasSan MarcosTexas78666-
Spectrum Medical Inc.DanvilleVirginia24541-
Swedish Medical CenterSeattleWashington98122-
Rheumatic Disease CenterGlendaleWisconsin53217-

Find similar trials in Birmingham, AL

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Achieve Clinical Research, LLC· Birmingham, ALUniversity of Alabama at Birmingham· Birmingham, ALArizona Arthritis & Rheumatology Research, PLLC· Glendale, AZUniversity of Arizona· Tucson, AZSt. Joseph Heritage Medical Group· Fullerton, CAMD Medical Corporation· Hemet, CA

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