이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

류마티스 관절염 환자를 대상으로 한 바리시티닙 연구 (RA-BRANCH)

2026년 6월 15일 업데이트: Eli Lilly and Company

류마티스 관절염 환자를 대상으로 한 바리시티닙의 무작위 통제 실용 3b/4상 연구

이 시판 후 연구는 류마티스 관절염(RA) 참가자에게 투여했을 때 정맥 혈전색전증 사건(VTE)과 관련하여 바리시티닙 대 종양 괴사 인자(TNF) 억제제의 안전성을 비교하기 위해 고안되었습니다.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

1050

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

설명

포함 기준:

  • 참가자는 다음 특성 중 하나 이상이 있어야 합니다.

    • 이 연구 이전에 VTE의 문서화된 증거
    • 만 60세 이상
    • 체질량 지수(BMI)가 30kg/m²(제곱미터당 킬로그램) 이상이거나
    • 50세 이상 60세 미만, BMI 25 이상 30kg/m² 미만
  • 참가자는 적어도 1개의 질병 수정 항류마티스 약물(DMARD)(합성 또는 생물학적 제제)에 대해 부적절한 반응 또는 불내성을 가지고 있어야 합니다.

제외 기준:

  • 참가자는 이전에 JAK(Janus kinase) 억제제를 사용한 적이 없거나 이전에 다음과 같은 TNF 억제제를 1개 이상 받은 적이 없어야 합니다.

    • RA에 대한 IR(효능 부족 또는 손실)로 인해 중단됨, 또는
    • 모든 적응증에 사용될 때 과민증(AE)으로 인해 중단됨
  • 참가자는 임신 중이거나 모유 수유 중이 아니어야 합니다.
  • 참가자는 하나 이상의 VTE를 가지고 있지 않아야 합니다.
  • 참가자는 암이 없어야 합니다.
  • 참가자는 활동성 대상 포진, 심각한 감염, 활동성 결핵 또는 기타 심각한 질병이 없어야 합니다.
  • 참가자는 연구 시작 4주 이내에 생백신을 접종하지 않아야 합니다.
  • 참가자는 연구 시작 4주 이내에 다른 임상 시험에 참여한 적이 없어야 합니다.
  • 참가자는 지난 1년간 IV 약물 사용, 기타 불법 약물 남용 또는 만성 알코올 남용 이력이 없어야 합니다.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: 바리시티닙
구두로 관리.
다른 이름들:
  • LY3009104
활성 비교기: 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.
의약품: TNF Inhibitor
Administered subcutaneously.
다른 이름들:
  • 에타너셉트
  • 아달리무맙
실험적: 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.
의약품: 바리시티닙
구두로 관리.
다른 이름들:
  • LY3009104

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Combined Baricitinib Dose Versus TNF Inhibitor]
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
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]
기간: 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]
기간: 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]
기간: 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]
기간: 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]
기간: 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]
기간: 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)

기타 결과 측정

결과 측정
측정값 설명
기간
Total Duration of Treatment Exposure for Combined Baricitinib Dose, Individual Baricitinib Dose and TNF Inhibitor
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Eli Lilly and Company

협력자

Incyte Corporation

수사관

  • 연구 책임자: 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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2020년 2월 14일

기본 완료 (실제)

2025년 5월 19일

연구 완료 (실제)

2025년 5월 19일

연구 등록 날짜

최초 제출

2019년 9월 10일

QC 기준을 충족하는 최초 제출

2019년 9월 10일

처음 게시됨 (실제)

2019년 9월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 15일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 17363
  • I4V-MC-JAJD (기타 식별자: Eli Lilly and Company)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

익명화된 개별 환자 수준 데이터는 연구 제안 및 서명된 데이터 공유 계약의 승인 시 안전한 액세스 환경에서 제공됩니다.

IPD 공유 기간

데이터는 미국과 EU에서 연구된 적응증의 1차 출판 및 승인 중 더 늦은 시점으로부터 6개월 후에 사용할 수 있습니다. 요청 시 데이터를 무기한 사용할 수 있습니다.

IPD 공유 액세스 기준

연구 제안은 독립적인 검토 패널의 승인을 받아야 하며 연구자는 데이터 공유 계약에 서명해야 합니다.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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