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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT03843125
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 long term study is to see how safe and effective the study drug known as baricitinib is in participants with systemic lupus erythematosus (SLE) who have completed the final treatment visit of study I4V-MC-JAHZ (NCT03616912) or study I4V-MC-JAIA (NCT03616964).

Key Dates

Start date
Sep 9, 2019
Status verified
May 2023
Primary completion
Apr 1, 2022
Completion
Apr 1, 2022

Study Design

Enrollment
1,147 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 2 mg Baricitinib
    Participants received one 2 mg Baricitinib tablet and one placebo tablet matching 4 mg Baricitinib administered orally every day (QD).
  • Experimental: 4 mg Baricitinib
    Participants received one 4 mg Baricitinib tablet and one placebo tablet matching 2 mg Baricitinib administered orally QD.
  • Experimental: Placebo to 2 mg Baricitinib
    Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 2 mg Baricitinib administered orally QD.
  • Experimental: Placebo to 4 mg Baricitinib
    Participants who received placebo in the originating study (JAHZ or JAIA) were randomized to receive 4 mg Baricitinib administered orally QD.

Primary Outcome Measure

Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Week 134 ]

Locations (61)

FacilityCityStateZIPSite coordinators
Achieve Clinical Research, LLCBirminghamAlabama35216-
Arizona Arthritis & Rheumatology ResearchPhoenixArizona85032-
Arizona Arthritis & Rheumatology Associates, P. C.TucsonArizona85704-
Wallace Rheumatic Studies CenterBeverly HillsCalifornia90211-
Medvin Clinical Research - WeidmannCovinaCalifornia91722-
Providence Medical FoundationFullertonCalifornia92835-
MD Medical CorporationHemetCalifornia92543-
ACRC StudiesPowayCalifornia92064-
Inland Rheumatology & Osteoporosis Medical GroupUplandCalifornia91786-
Medvin Clinical Research - WeidmannWhittierCalifornia90602-
Denver Arthritis Clinic - LowryDenverColorado80230-
New England Research AssociatesBridgeportConnecticut06606-
Arthritis and Rheumatic DiseaseAventuraFlorida33180-
Clinical Research of West Florida, Inc. (Clearwater)ClearwaterFlorida33765-
Lakes Research, LLCMiami LakesFlorida33014-
Millennium ResearchOrmond BeachFlorida32174-
Integral Rheumatology & Immunology SpecialistsPlantationFlorida33324-
IRIS Research and Development, LLCPlantationFlorida33324-
ForCare Clinical ResearchTampaFlorida33613-1244-
Tampa Medical Group, P.A.TampaFlorida33614-
Emory UniversityAtlantaGeorgia30322-
Piedmont HealthcareAtlantaGeorgia30318-
North Georgia Rheumatology, PCLawrencevilleGeorgia30046-
Arthritis Center of LexingtonLexingtonKentucky40504-
Johns Hopkins Asthma and Allergy CenterBaltimoreMaryland21224-
Henry Ford Health SystemDetroitMichigan48202-
Advanced Rheumatology, PCLansingMichigan48910-
Clinical Research Institute of Michigan, LLCSaint Clair ShoresMichigan48081-
Glacir View Research InstituteKalispellMontana59901-
Allied Clinical ResearchRenoNevada89519-
Arthritis and Osteoporosis Associates of New MexicoLas CrucesNew Mexico88011-
St. Lawrence Health SystemCantonNew York13617-
The Feinstein Institute for Medical ResearchManhassetNew York11030-
Columbia University Medical CenterNew YorkNew York10032-
NYU LangoneNew YorkNew York11201-
SUNY Upstate Medical UniversitySyracuseNew York13210-
Box Arthritis & Rheumatology of the Carolinas, PLLCCharlotteNorth Carolina28210-
Joint and Muscle Medical CareCharlotteNorth Carolina28204-
Medication ManagementGreensboroNorth Carolina27408-
Cincinnati Rheumatic Disease Study GroupCincinnatiOhio45242-
Paramount Medical ResearchMiddleburg HeightsOhio44130-
Arthritis & Rheumatology Center of Oklahoma PLLCOklahoma CityOklahoma73102-
Oklahoma Medical Research FoundationOklahoma CityOklahoma73104-5046-
East Penn Rheumatology AssociatesBethlehemPennsylvania18015-
Clinical Research Center of Reading,LLCWyomissingPennsylvania19610-
Articularis Healthcare d/b/a/ Low Country Rheumatology, PASummervilleSouth Carolina29486-
Eagle MedicalCrossvilleTennessee38555-
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-
Advanced Rheumatology of HoustonThe WoodlandsTexas77382-
Arthritis Clinic of Northern VA, P.C.ArlingtonVirginia22205-
Spectrum Medical Inc.DanvilleVirginia24541-
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, ALArizona Arthritis & Rheumatology Research· Phoenix, AZArizona Arthritis & Rheumatology Associates, P. C.· Tucson, AZWallace Rheumatic Studies Center· Beverly Hills, CAMedvin Clinical Research - Weidmann· Covina, CAProvidence Medical Foundation· Fullerton, CA

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