Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

En undersøgelse af baricitinib hos deltagere med reumatoid arthritis (RA-BRANCH)

15. juni 2026 opdateret af: Eli Lilly and Company

En randomiseret, kontrolleret pragmatisk fase 3b/4 undersøgelse af baricitinib hos patienter med reumatoid arthritis

Denne post-marketing undersøgelse er designet til at sammenligne sikkerheden af ​​baricitinib versus tumornekrosefaktor (TNF)-hæmmere med hensyn til venøse tromboemboliske hændelser (VTE'er), når de gives til deltagere med reumatoid arthritis (RA).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1050

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Deltagere skal have mindst én af følgende egenskaber:

    • Dokumenteret bevis for en VTE før denne undersøgelse
    • Mindst 60 år
    • Et kropsmasseindeks (BMI) større end eller lig med 30 kilogram pr. kvadratmetre (kg/m²), eller
    • Alder 50 til under 60 år og BMI 25 til under 30 kg/m²
  • Deltagerne skal have en utilstrækkelig respons eller intolerance over for mindst 1 sygdomsmodificerende antirheumatisk medicin (DMARD) (syntetisk eller biologisk)

Ekskluderingskriterier:

  • Deltageren må ikke tidligere have brugt en Janus kinase (JAK) hæmmer eller have modtaget mere end 1 tidligere TNF-hæmmer, som var:

    • seponeret for IR (manglende eller tab af effekt) for RA, eller
    • seponeret på grund af intolerance (AE), når det bruges til enhver indikation
  • Deltagerne må ikke være gravide eller ammende
  • Deltagerne må ikke have haft mere end én VTE
  • Deltagerne må ikke have kræft
  • Deltagerne må ikke have aktiv herpes zoster, alvorlig infektion, aktiv tuberkulose eller anden alvorlig sygdom
  • Deltagerne må ikke have fået en levende vaccine inden for fire uger efter studiestart
  • Deltagerne må ikke have deltaget i andre kliniske forsøg inden for fire uger efter studiestart
  • Deltagerne må ikke have en historie med intravenøs stofbrug, andet ulovligt stofmisbrug eller kronisk alkoholmisbrug i det seneste år

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: Baricitinib
Indgives oralt.
Andre navne:
  • 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.
Medicin: TNF Inhibitor
Administered subcutaneously.
Andre navne:
  • Etanercept
  • Adalimumab
Eksperimentel: 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.
Medicin: Baricitinib
Indgives oralt.
Andre navne:
  • LY3009104

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Eli Lilly and Company

Samarbejdspartnere

Incyte Corporation

Efterforskere

  • 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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. februar 2020

Primær færdiggørelse (Faktiske)

19. maj 2025

Studieafslutning (Faktiske)

19. maj 2025

Datoer for studieregistrering

Først indsendt

10. september 2019

Først indsendt, der opfyldte QC-kriterier

10. september 2019

Først opslået (Faktiske)

12. september 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymiserede individuelle data på patientniveau vil blive leveret i et sikkert adgangsmiljø efter godkendelse af et forskningsforslag og en underskrevet datadelingsaftale.

IPD-delingstidsramme

Data er tilgængelige 6 måneder efter den primære offentliggørelse og godkendelse af den undersøgte indikation i USA og EU, alt efter hvad der er senere. Data vil være tilgængelige på ubestemt tid for anmodning.

IPD-delingsadgangskriterier

Et forskningsforslag skal godkendes af et uafhængigt bedømmelsespanel, og forskere skal underskrive en datadelingsaftale.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner