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En studie av baricitinib hos deltakere med revmatoid artritt (RA-BRANCH)

15. juni 2026 oppdatert av: Eli Lilly and Company

En randomisert, kontrollert pragmatisk fase 3b/4-studie av baricitinib hos pasienter med revmatoid artritt

Denne post-markedsføringsstudien er designet for å sammenligne sikkerheten til baricitinib versus tumornekrosefaktor (TNF)-hemmere med hensyn til venøse tromboemboliske hendelser (VTE) når de gis til deltakere med revmatoid artritt (RA).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

1050

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Arizona
      • Chandler, Arizona, Forente stater, 85225
        • Arizona Research Clinic PLLC
      • Mesa, Arizona, Forente stater, 85202
        • Arizona Arthritis & Rheumatology Associates, P. C.
      • Paradise Valley, Arizona, Forente stater, 85253
        • Arizona Arthritis & Rheumatology Research
      • Peoria, Arizona, Forente stater, 85381
        • Sun Valley Arthritis Center, LTD
      • Phoenix, Arizona, Forente stater, 85037
        • Arizona Arthritis & Rheumatology Associates
    • Arkansas
      • Jonesboro, Arkansas, Forente stater, 72401
        • Arthritis and Rheumatism Associates
    • California
      • Burbank, California, Forente stater, 91505
        • Providence St. Joseph's Medical Center
      • Canoga Park, California, Forente stater, 91303
        • Hope Clinical Research, Inc.
      • Covina, California, Forente stater, 91722
        • Medvin Clinical Research - Covina
      • El Cajon, California, Forente stater, 92020
        • Triwest Research Associates LLC
      • Huntington Beach, California, Forente stater, 92648
        • Newport Huntington Med Grp
      • La Mesa, California, Forente stater, 91942
        • BioSolutions Clinical Research Center
      • Los Alamitos, California, Forente stater, 90720
        • Valerius Medical Group and Research Center of Greater Long Beach
      • Monterey Park, California, Forente stater, 91754
        • R. Srinivasan, M.D., Inc. dba Monterey Park Medical Center
      • Poway, California, Forente stater, 92064
        • ACRC Studies
      • Rancho Mirage, California, Forente stater, 92270
        • Desert Medical Advances
      • San Diego, California, Forente stater, 92120
        • Purushotham & Akther Kotha MD Inc
      • San Leandro, California, Forente stater, 94578
        • East Bay Rheumatology Medical Group, Inc
      • Santa Rosa, California, Forente stater, 95403
        • Providence Medical Foundation
      • Tujunga, California, Forente stater, 91042
        • Dan La, MD Inc
      • Tustin, California, Forente stater, 92780
        • Office: Dr Robin K Dore
      • Upland, California, Forente stater, 91786
        • Inland Rheumatology & Osteoporosis Medical Group
      • West Hills, California, Forente stater, 91307
        • Nazanin Firooz, MD Inc.
      • Whittier, California, Forente stater, 90602
        • Medvin Clinical Research - Whittier
    • Connecticut
      • Danbury, Connecticut, Forente stater, 06810
        • Danbury Clinical Research, LLC
    • Delaware
      • Lewes, Delaware, Forente stater, 19958
        • Delaware Arthritis
    • Florida
      • DeBary, Florida, Forente stater, 32713
        • Omega Research Debary, LLC
      • Fort Lauderdale, Florida, Forente stater, 33334
        • Cria Center for Rheumatology
      • Gainesville, Florida, Forente stater, 32607
        • SIMED Health
      • Hollywood, Florida, Forente stater, 33024
        • GNP Research at Mark Jaffe, MD
      • Lake Worth, Florida, Forente stater, 33467 2991
        • Rheumatology Center Of Palm Beach, Pllc
      • Margate, Florida, Forente stater, 33063
        • Arthritis and Rheumatology Center of South Florida
      • Miami, Florida, Forente stater, 33185
        • Felicidad Medical Research
      • Miami, Florida, Forente stater, 33155
        • Miami Clinical Reserach
      • Orlando, Florida, Forente stater, 32806
        • Rheumatology Associates of Central Florida
      • Orlando, Florida, Forente stater, 32819
        • Heuer MD Research
      • Orlando, Florida, Forente stater, 32827
        • UCF Health Lake Nona Orlando
      • Plantation, Florida, Forente stater, 33324
        • IRIS Research and Development, LLC
      • St. Petersburg, Florida, Forente stater, 33705
        • BayCare Health System Inc
      • Tamarac, Florida, Forente stater, 33321
        • West Broward Rheumatology Associates
      • Tampa, Florida, Forente stater, 33613
        • Avita Clinical Research
      • Tampa, Florida, Forente stater, 33614
        • Tampa Medical Group, P.A.
      • Zephyrhills, Florida, Forente stater, 33542-7505
        • Florida Medical Clinic LLC
    • Georgia
      • Atlanta, Georgia, Forente stater, 30342
        • Arthritis & Rheumatology of Georgia
      • Gainesville, Georgia, Forente stater, 30501
        • Arthritis Center of North Georgia
    • Idaho
      • Boise, Idaho, Forente stater, 83702
        • St Luke's Clinic - Intermountain Orthopaedics
    • Illinois
      • Hinsdale, Illinois, Forente stater, 60521
        • Hinsdale Orthopaedics, Illinois Bone and Joint
      • Rockford, Illinois, Forente stater, 61114
        • OrthoIllinois
      • Rockford, Illinois, Forente stater, 61107
        • Rockford Orthopedic Associates
      • Schaumburg, Illinois, Forente stater, 60195
        • Greater Chicago Specialty Physicians, LLC
      • Skokie, Illinois, Forente stater, 60076
        • Center of Robert Hozman
    • Indiana
      • South Bend, Indiana, Forente stater, 46617
        • Beacon Medical Group Clinical Research
    • Kentucky
      • Bowling Green, Kentucky, Forente stater, 42101
        • Graves-Gilbert Clinic
      • Hopkinsville, Kentucky, Forente stater, 42240
        • Western KY Rheumatology PLLC
    • Louisiana
      • Lake Charles, Louisiana, Forente stater, 70605
        • Accurate Clinical Research
      • Monroe, Louisiana, Forente stater, 71203
        • Arthritis and Diabetes Clinic, Inc.
      • New Orleans, Louisiana, Forente stater, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Cumberland, Maryland, Forente stater, 21502
        • Klein and Associates MD, PA
    • Massachusetts
      • Fall River, Massachusetts, Forente stater, 02721
        • NECCR PrimaCare Research
    • Michigan
      • Grand Blanc, Michigan, Forente stater, 48439
        • Michigan Rheumatology Group
      • Okemos, Michigan, Forente stater, 48864
        • Pandit Rheumatology PC
    • Missouri
      • Jefferson City, Missouri, Forente stater, 65109
        • Jefferson City Medical Group
      • Springfield, Missouri, Forente stater, 65807
        • Clinvest Research LLC
      • St Louis, Missouri, Forente stater, 63131
        • West County Rheumatology
    • Nevada
      • Henderson, Nevada, Forente stater, 89104
        • Lovelace Scientific Resources
      • Reno, Nevada, Forente stater, 89519
        • Allied Clinical Research
    • New Hampshire
      • Lebanon, New Hampshire, Forente stater, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Somerset, New Jersey, Forente stater, 08873
        • Arthritis Care Medical Center
      • Toms River, New Jersey, Forente stater, 08757
        • Atlantic Coastal Research
      • West Long Branch, New Jersey, Forente stater, 07764
        • Sahni Rheumatology & Therapy PC
    • New York
      • New York, New York, Forente stater, 10016
        • NYU Langone
    • North Carolina
      • Greensboro, North Carolina, Forente stater, 27408
        • Medication Management
      • Hickory, North Carolina, Forente stater, 28601
        • PMG Research of Hickory, LLC
      • Leland, North Carolina, Forente stater, 28451
        • Cape Fear Arthritis Care
      • Wilmington, North Carolina, Forente stater, 28401
        • Carolina Arthritis Associates
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45242
        • Cincinnati Arthritis Associates
      • Marion, Ohio, Forente stater, 43302
        • Craig S Thompson MD LLC
      • Middleburg Heights, Ohio, Forente stater, 44130
        • Paramount Medical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73103
        • Arthritis & Rheumatology Center of Oklahoma PLLC
    • Oregon
      • Corvallis, Oregon, Forente stater, 97330
        • Good Samaritan Hospital Corvallis
    • Pennsylvania
      • Cranberry Township, Pennsylvania, Forente stater, 15090
        • Advanced Rheumatology and Arthritis Research Center, PC
      • Duncansville, Pennsylvania, Forente stater, 16635
        • Altoona Center for Clinical Research
      • Wyomissing, Pennsylvania, Forente stater, 19610
        • Pennsylvania Regional Center for Arthritis and Osteoporosis Research
    • South Carolina
      • North Charleston, South Carolina, Forente stater, 29406
        • Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
    • South Dakota
      • Rapid City, South Dakota, Forente stater, 57701
        • Monument Health Rapid City Hospital
    • Tennessee
      • Crossville, Tennessee, Forente stater, 38555
        • Cumberland Rheumatology
      • Jackson, Tennessee, Forente stater, 38305
        • West Tennessee Research Institute
      • Nashville, Tennessee, Forente stater, 37203
        • Nashville Arthritis and Rheumatology
    • Texas
      • Allen, Texas, Forente stater, 75013
        • Accent Clinical Research Professionals, LLC
      • Amarillo, Texas, Forente stater, 79124
        • Amarillo Center for Clinical Research
      • College Station, Texas, Forente stater, 77845
        • Arthritis & Osteoporosis Clinic of Brazos Valley
      • Dallas, Texas, Forente stater, 75235
        • Metroplex Clinical Research Center
      • El Paso, Texas, Forente stater, 79912
        • El Paso Integrated Physicians Group, P.A., an Elligo Health Research, Inc. Healthcare Enabled Research Organization
      • Houston, Texas, Forente stater, 77008
        • Pioneer Research Solutions
      • Houston, Texas, Forente stater, 77043
        • Biopharma Informatic, LLC
      • Houston, Texas, Forente stater, 77084
        • Accurate Clinical Management - Houston
      • Houston, Texas, Forente stater, 77002
        • UDL Clinical Research, LLC
      • Katy, Texas, Forente stater, 77494
        • Houston Rheumatology & Arthritis Specialists
      • Katy, Texas, Forente stater, 77494
        • R and H Clinical Research
      • Katy, Texas, Forente stater, 77450
        • Synergy Group US
      • Mansfield, Texas, Forente stater, 76063
        • Prime Clinical Research
      • Mesquite, Texas, Forente stater, 75150
        • Southwest Rheumatology, P.A.
      • Pearland, Texas, Forente stater, 77584
        • Advanced Clinical Research Center of Houston
      • Plano, Texas, Forente stater, 75007
        • Clinrx Research Joseph INC.
      • Pleasanton, Texas, Forente stater, 78064
        • Violeta T. Baddour, MD
      • San Antonio, Texas, Forente stater, 78229
        • Accurate Clinical Research, Inc.
      • Sugar Land, Texas, Forente stater, 77479
        • Mt. Olympus Medical Research
      • Sugar Land, Texas, Forente stater, 77479
        • Fort Bend Clinical Research, LLC
      • Sugar Land, Texas, Forente stater, 77479
        • Accurate Clinical Management
      • Temple, Texas, Forente stater, 76508
        • Baylor Scott & White Health
      • The Woodlands, Texas, Forente stater, 77380
        • North Houston Rheumatology Associates
      • Tomball, Texas, Forente stater, 77375
        • Dynamed Clinical Research, LP d/b/a DM Clinical Research
    • Virginia
      • Chesapeake, Virginia, Forente stater, 23320
        • Center for Arthritis and Rheumatic Diseases, PC
      • Danville, Virginia, Forente stater, 24541
        • Spectrum Medical Inc.
      • Manassas, Virginia, Forente stater, 20109
        • Arthritis & Osteoporosis Center of Northern Virinia
      • Newport News, Virginia, Forente stater, 23606
        • TPMG Rheumatology/TPMG Clinical Research
    • Washington
      • Spokane, Washington, Forente stater, 99204
        • Arthritis Northwest, PLLC
    • West Virginia
      • Beckley, West Virginia, Forente stater, 25801
        • Rheumatology & Pulmonary Clinic
    • Wisconsin
      • Milwaukee, Wisconsin, Forente stater, 53211
        • Rheumatic Disease Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Deltakere må ha minst én av følgende egenskaper:

    • Dokumentert bevis på en VTE før denne studien
    • Minst 60 år
    • En kroppsmasseindeks (BMI) større enn eller lik 30 kilogram per kvadratmeter kvadrat (kg/m²), eller
    • Alder 50 til under 60 år og BMI 25 til mindre enn 30 kg/m²
  • Deltakerne må ha en utilstrekkelig respons eller intoleranse overfor minst 1 sykdomsmodifiserende antireumatiske legemidler (DMARD) (syntetisk eller biologisk)

Ekskluderingskriterier:

  • Deltakeren må ikke ha tidligere brukt en Janus kinase (JAK)-hemmer eller ha mottatt mer enn 1 tidligere TNF-hemmer som var:

    • seponert for IR (manglende eller tap av effekt) for RA, eller
    • seponert på grunn av intoleranse (AE) når den brukes til enhver indikasjon
  • Deltakere må ikke være gravide eller ammende
  • Deltakere må ikke ha hatt mer enn én VTE
  • Deltakere må ikke ha kreft
  • Deltakere må ikke ha aktiv herpes zoster, alvorlig infeksjon, aktiv tuberkulose eller annen alvorlig sykdom
  • Deltakerne må ikke ha fått en levende vaksine innen fire uker etter studiestart
  • Deltakere må ikke ha deltatt i noen annen klinisk studie innen fire uker etter studiestart
  • Deltakere må ikke ha en historie med intravenøs narkotikabruk, annet ulovlig narkotikamisbruk eller kronisk alkoholmisbruk det siste året

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Baricitinib 4mg
Participants received 4 mg of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.
Legemiddel: Baricitinib
Administrert oralt.
Andre navn:
  • LY3009104
Aktiv komparator: Tumor Necrosis Factor (TNF) Inhibitor
Participants received a TNF inhibitor (adalimumab or etanercept) administered according to approved local labeling until the planned number of adjudicated primary endpoint events occurred or until the DMC recommended early termination.
Legemiddel: TNF Inhibitor
Administered subcutaneously.
Andre navn:
  • Etanercept
  • Adalimumab
Eksperimentell: Baricitinib 2mg
Participants received 2 milligrams (mg) of baricitinib once daily until the planned number of adjudicated primary endpoint events occurred or until the data monitoring committee (DMC) recommended early termination. Those with inadequate response at 1-year after start of treatment with baricitinib 2 mg could receive rescue treatment with baricitinib 4 mg.
Legemiddel: Baricitinib
Administrert oralt.
Andre navn:
  • LY3009104

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Combined Baricitinib Dose Versus TNF Inhibitor]
Tidsramme: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Time from first dose of study treatment to first event of VTE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/Body Mass Index (BMI) combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Arterial Thromboembolic Event (ATE) [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
Tidsramme: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Time from first dose of study treatment to first ATE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Major Adverse Cerebro-Cardiovascular Event (MACE) [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
Tidsramme: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Time from first dose of study treatment to first MACE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Malignancy (Excluding Nonmelanoma Skin Cancer [NMSC]) [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
Tidsramme: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Time from first dose of study treatment to first malignancy (excluding NMSC) was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Opportunistic Infection [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
Tidsramme: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Time from first dose of study treatment to first opportunistic infection was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Serious Infection [Combined and Individual Baricitinib Dose Versus TNF Inhibitor]
Tidsramme: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Time from first dose of study treatment to first serious infection was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Individual Baricitinib Dose Versus TNF Inhibitor]
Tidsramme: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Time from first dose of study treatment to first event of VTE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/BMI combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total Duration of Treatment Exposure for Combined Baricitinib Dose, Individual Baricitinib Dose and TNF Inhibitor
Tidsramme: From the date of first dose of study drug up to the last dose (approximately up to 5.3 years)

Duration of exposure was calculated as:

  • Baricitinib 2mg exposure = date of last baricitinib 2mg treatment - date of first baricitinib 2mg dose + 1. For participants who were rescued from baricitinib 2 mg to 4 mg, their drug exposure after rescue was censored and not counted as exposure to baricitinib 2mg.
  • Baricitinib 4mg exposure = date of last baricitinib 4mg treatment - date of first baricitinib 4mg dose + 1.

TNF inhibitor exposure = date of last TNFi (adalimumab or etanercept) - date of first TNFi dose (adalimumab or etanercept) + 1, regardless of treatment cycling from adalimumab to etanercept or vice versa.

- Total baricitinib exposure (2/4 mg) = date of last baricitinib (2mg or 4mg) treatment - date of first baricitinib (2mg or 4mg) dose + 1, regardless of rescue from baricitinib 2mg to baricitinib 4mg.

Patient-years is calculated as sum of duration of exposure in days for all patients in dosing regimen divided by 365.25.
From the date of first dose of study drug up to the last dose (approximately up to 5.3 years)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Eli Lilly and Company

Samarbeidspartnere

Incyte Corporation

Etterforskere

  • Studieleder: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

14. februar 2020

Primær fullføring (Faktiske)

19. mai 2025

Studiet fullført (Faktiske)

19. mai 2025

Datoer for studieregistrering

Først innsendt

10. september 2019

Først innsendt som oppfylte QC-kriteriene

10. september 2019

Først lagt ut (Faktiske)

12. september 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 17363
  • I4V-MC-JAJD (Annen identifikator: Eli Lilly and Company)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymiserte individuelle pasientnivådata vil bli gitt i et sikkert tilgangsmiljø ved godkjenning av et forskningsforslag og en signert datadelingsavtale.

IPD-delingstidsramme

Data er tilgjengelig 6 måneder etter den primære publisering og godkjenning av indikasjonen studert i USA og EU, avhengig av hva som er senere. Data vil være tilgjengelig på ubestemt tid for forespørsel.

Tilgangskriterier for IPD-deling

Et forskningsforslag må godkjennes av et uavhengig granskningspanel og forskere må signere en datadelingsavtale.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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