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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT03616964
Phase
PHASE3
Status
Completed

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
Nov 2022
Primary completion
Sep 24, 2021
Completion
Oct 20, 2021

Study Design

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

Arms

  • Experimental: 2 milligram (mg) Baricitinib
    Participants received one 2 mg baricitinib tablet and one placebo tablet matching 4 mg baricitinib administered orally once daily (QD) for 52 weeks.
  • Experimental: 4 mg Baricitinib
    Participants received one 4 mg baricitinib tablet and one placebo tablet matching 2 mg baricitinib administered orally QD for 52 weeks.
  • Placebo Comparator: Placebo
    Participants received 2 placebo tablets: one placebo tablet matching 4 mg baricitinib and one placebo tablet matching 2 mg baricitinib administered orally 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 (39)

FacilityCityStateZIPSite coordinators
University of Arizona Arthritis CenterGilbertArizona85297-
Arizona Arthritis & Rheumatology ResearchPhoenixArizona85302-
Arizona Arthritis & Rheumatology Associates, P. C.TucsonArizona85704-
Wallace Rheumatic Studies CenterBeverly HillsCalifornia90211-
Medvin Clinical Research - WeidmannCovinaCalifornia91722-
Office: Dr Robin K DoreTustinCalifornia92780-
Inland Rheumatology & Osteoporosis Medical GroupUplandCalifornia91786-
Denver Arthritis Clinic - LowryDenverColorado80230-
Clinical Research of West Florida, Inc. (Clearwater)ClearwaterFlorida33765-
Millennium ResearchOrmond BeachFlorida32174-
Integral Rheumatology & Immunology SpecialistsPlantationFlorida33324-
Clinical Research of West FloridaTampaFlorida33603-
Tampa Medical Group, P.A.TampaFlorida33614-
Emory UniversityAtlantaGeorgia30322-
Northside HospitalAtlantaGeorgia30342-
North Georgia Rheumatology, PCLawrencevilleGeorgia30046-
Arthritis Center of LexingtonLexingtonKentucky40504-
Johns Hopkins University School of MedicineBaltimoreMaryland21224-6801-
Advanced Rheumatology, PCLansingMichigan48910-
Glacier View Research Institute - EndocrinologyKalispellMontana59901-
Innovative Health ResearchLas VegasNevada89128-
Albuquerque Clinical Trials, Inc.AlbuquerqueNew Mexico87102-
Arthritis and Osteoporosis Associates of New MexicoLas CrucesNew Mexico88011-
St. Lawrence Health SystemCantonNew York13617-
New York University Medical CenterNew YorkNew York10016-
SUNY Upstate Medical UniversitySyracuseNew York13210-
Box Arthritis & Rheumatology of the Carolinas, PLLCCharlotteNorth Carolina28210-
Joint and Muscle Medical CareCharlotteNorth Carolina28204-
Cincinnati Rheumatic Disease Study GroupCincinnatiOhio45242-
Oklahoma Medical Research FoundationOklahoma CityOklahoma73104-
Clinical Research Center of Reading,LLCWyomissingPennsylvania19610-
Articularis Healthcare d/b/a/ Low Country Rheumatology, PASummervilleSouth Carolina29486-
Eagle MedicalCrossvilleTennessee38555-
Dr. Dhiman Basu Private PracticeColleyvilleTexas76034-
Metroplex Clinical Research CenterDallasTexas75231-
Advanced Rheumatology of HoustonThe WoodlandsTexas77382-
Clear Lake SpecialtiesWebsterTexas77598-
Arthritis Clinic of Northern VA, P.C.ArlingtonVirginia22205-
Spectrum Medical Inc.DanvilleVirginia24541-

Find similar trials in Gilbert, AZ

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
University of Arizona Arthritis Center· Gilbert, AZArizona Arthritis & Rheumatology Research· Phoenix, AZArizona Arthritis & Rheumatology Associates, P. C.· Tucson, AZWallace Rheumatic Studies Center· Beverly Hills, CAMedvin Clinical Research - Weidmann· Covina, CAOffice: Dr Robin K Dore· Tustin, CA

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