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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT02708095
Phase
PHASE2
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 main purpose of this study is to evaluate the efficacy and safety of the study drug known as baricitinib in participants with systemic lupus erythematosus.

Key Dates

Start date
Mar 24, 2016
Status verified
Dec 2017
Primary completion
Oct 12, 2017
Completion
Nov 9, 2017

Study Design

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

Arms

  • Experimental: 2 mg Baricitinib
    Participants received 2 (milligrams) mg of Baricitinib tablet orally once a day for 24 weeks.
  • Experimental: 4 mg Baricitinib
    Participants received 4 mg of Baricitinib tablet orally once a day for 24 weeks.
  • Placebo Comparator: Placebo
    Participants received Placebo orally once daily (QD) for 24 weeks.

Primary Outcome Measure

Percentage of Participants Who Achieve Remission of Arthritis and/or Rash Defined by the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) [ Time Frame: Week 24 ]

Locations (27)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85724-
Wallace Rheumatic Study CenterBeverly HillsCalifornia90211-
Medvin Clinical ResearchCovinaCalifornia91723-
TriWest Research AssocaitesEl CajonCalifornia92020-
University of CaliforniaLa JollaCalifornia92037-
Desert Medical AdvancesPalm DesertCalifornia92260-
Inlande Rheumatology Clinical TrialsUplandCalifornia91786-
Denver Arthritis CenterDenverColorado80230-
New Horizon Research CenterMiamiFlorida33175-
West Broward Rheumatology Associates, IncTamaracFlorida33321-
Clinical Research of West Florida, Inc.TampaFlorida33603-
Kansas City Internal Medicine ResearchOverland ParkKansas66209-
The Arthritis & Diabetes Clinic Inc.MonroeLouisiana71203-
Louisiana State University Health Sciences CenterShreveportLouisiana71103-
University of MichiganAnn ArborMichigan48109-
Arthritis ConsultantsSt LouisMissouri63141-
Clayton Medical ResearchSt LouisMissouri63117-
Albuquerque Clinical TrialsAlbuquerqueNew Mexico87102-
North Shore University Hospital at Great NeckGreat NeckNew York11021-
The Ohio State UniversityColumbusOhio43203-
Paramount Medical ResearchMiddleburg HeightsOhio44130-
Arthritis & Rheumatology Center of Oklahoma PLLCOklahoma CityOklahoma73103-
Oklahoma Medical Research FoundationOklahoma CityOklahoma73104-5046-
The Oklahoma Center For Arthritis TherapyTulsaOklahoma74104-
East Penn RheumatologyBethlehemPennsylvania18015-
Clinical Research Center of Reading, LLCWyomissingPennsylvania19610-
Accent Clinical Research Professionals, LLCAllenTexas75013-

Find similar trials in Tucson, AZ

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
University of Arizona· Tucson, AZWallace Rheumatic Study Center· Beverly Hills, CAMedvin Clinical Research· Covina, CATriWest Research Assocaites· El Cajon, CAUniversity of California· La Jolla, CADesert Medical Advances· Palm Desert, CA

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