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Uno studio su Baricitinib nei partecipanti con artrite reumatoide (RA-BRANCH)

15 giugno 2026 aggiornato da: Eli Lilly and Company

Uno studio pragmatico randomizzato e controllato di fase 3b/4 su Baricitinib in pazienti con artrite reumatoide

Questo studio post-marketing è progettato per confrontare la sicurezza di baricitinib rispetto agli inibitori del fattore di necrosi tumorale (TNF) rispetto agli eventi tromboembolici venosi (VTE) quando somministrato a partecipanti con artrite reumatoide (AR).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1050

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  • I partecipanti devono avere almeno una delle seguenti caratteristiche:

    • Evidenza documentata di un TEV prima di questo studio
    • Almeno 60 anni di età
    • Un indice di massa corporea (BMI) maggiore o uguale a 30 chilogrammi per metro quadrato (kg/m²), o
    • Età da 50 a meno di 60 anni e BMI da 25 a meno di 30 kg/m²
  • I partecipanti devono avere una risposta inadeguata o intolleranza ad almeno 1 farmaci antireumatici modificanti la malattia (DMARD) (sintetici o biologici)

Criteri di esclusione:

  • Il partecipante non deve aver utilizzato in precedenza un inibitore della Janus chinasi (JAK) o aver ricevuto più di 1 precedente inibitore del TNF che era:

    • interrotto per IR (mancanza o perdita di efficacia) per RA, o
    • interrotto per intolleranza (AE) quando utilizzato per qualsiasi indicazione
  • I partecipanti non devono essere in gravidanza o in allattamento
  • I partecipanti non devono aver avuto più di un TEV
  • I partecipanti non devono avere il cancro
  • I partecipanti non devono avere herpes zoster attivo, infezione grave, tubercolosi attiva o qualsiasi altra malattia grave
  • I partecipanti non devono aver ricevuto un vaccino vivo entro quattro settimane dall'inizio dello studio
  • I partecipanti non devono aver partecipato a nessun altro studio clinico entro quattro settimane dall'inizio dello studio
  • I partecipanti non devono avere una storia di uso di droghe per via endovenosa, abuso di altre droghe illecite o abuso cronico di alcol nell'ultimo anno

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: Baricitinib
Somministrato per via orale.
Altri nomi:
  • LY3009104
Comparatore attivo: 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.
Droga: TNF Inhibitor
Administered subcutaneously.
Altri nomi:
  • Etanercept
  • Adalimumab
Sperimentale: 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.
Droga: Baricitinib
Somministrato per via orale.
Altri nomi:
  • LY3009104

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Combined Baricitinib Dose Versus TNF Inhibitor]
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
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]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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]
Lasso di tempo: 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)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Total Duration of Treatment Exposure for Combined Baricitinib Dose, Individual Baricitinib Dose and TNF Inhibitor
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Eli Lilly and Company

Collaboratori

Incyte Corporation

Investigatori

  • Direttore dello studio: 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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

14 febbraio 2020

Completamento primario (Effettivo)

19 maggio 2025

Completamento dello studio (Effettivo)

19 maggio 2025

Date di iscrizione allo studio

Primo inviato

10 settembre 2019

Primo inviato che soddisfa i criteri di controllo qualità

10 settembre 2019

Primo Inserito (Effettivo)

12 settembre 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 17363
  • I4V-MC-JAJD (Altro identificatore: Eli Lilly and Company)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

I dati anonimi a livello di singolo paziente saranno forniti in un ambiente di accesso sicuro previa approvazione di una proposta di ricerca e di un accordo di condivisione dei dati firmato.

Periodo di condivisione IPD

I dati sono disponibili 6 mesi dopo la pubblicazione primaria e l'approvazione dell'indicazione studiata negli Stati Uniti e nell'UE, se successiva. I dati saranno disponibili a tempo indeterminato per la richiesta.

Criteri di accesso alla condivisione IPD

Una proposta di ricerca deve essere approvata da un comitato di revisione indipendente e i ricercatori devono firmare un accordo di condivisione dei dati.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

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