Back to resultsA Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis (RESOLUTION-1)
Primary Purpose
Rheumatoid Arthritis, Arthritis, Joint Diseases
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Peresolimab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Have a diagnosis of adult onset rheumatoid arthritis (RA) for at least 3 months prior to screening, as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria
Have moderately-to-severely active RA, at screening and baseline, defined by the presence of
- ≥6 swollen joints based on 66 joint count, and
- ≥6 tender joints based on 68 joint count.
- Have had an inadequate response to, or loss of response or intolerance to at least 1 conventional synthetic DMARD (csDMARD), biologic DMARD ( bDMARD), or targeted synthetic DMARD (tsDMARD) treatment.
Exclusion Criteria:
- Have Class IV RA according to ACR revised response criteria.
Have presence of 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to
- poorly controlled diabetes or hypertension
- chronic kidney disease stage IIIb, IV, or V
- symptomatic heart failure according to New York Heart Association Class II, III, or IV
- myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, within the past 12 months before randomization
- severe chronic pulmonary disease, for example, requiring oxygen therapy
major chronic inflammatory disease or connective tissue disease other than RA, including but not limited to,
- systemic lupus erythematosus
- psoriatic arthritis
- axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis
- reactive arthritis
- gout
- scleroderma
- polymyositis
- dermatomyositis
- active fibromyalgia, or
- multiple sclerosis
Sites / Locations
- Accel Research Sites - Birmingham Clinical Research Unit
- Arizona Arthritis & Rheumatology Research PLLC
- Arizona Arthritis & Rheumatology Research, PLLC
- Arizona Arthritis & Rheumatology Research, PLLC
- Arizona Arthritis & Rheumatology Associates
- Medvin Clinical Research - Metyas
- Providence Medical Foundation
- Christine Thai, MD
- Desert Medical Advances
- Wolverine Clinical Trials
- Dan La, MD Inc
- Medvin Clinical Research - Su
- Denver Arthritis Clinic
- Tekton Research - Fort Collins - East Harmony Road
- HARAC Research Corp
- Encore Medical Research of Boynton Beach
- Clinical Research of West Florida, Inc. (Clearwater)
- Suncoast Clinical Research, Inc.
- West Broward Rheumatology Associates
- Clinical Research of West Florida
- ForCare Clinical Research
- Baycare Medical Group
- Hinsdale Orthopaedics - llinois Bone & Joint Institute
- Accurate Clinical Research
- Great Lakes Research Group, Inc.
- AA Medical Research Center
- Arthritis and Rheumatology Center of MI - Rochester Hills
- Saint Louis Rheumatology
- Clinvest Headlands Llc
- Arthritis & Osteoporosis Associates - Freehold
- Albuquerque Center for Rheumatology
- Albuquerque Clinical Trials, Inc.
- Joseph S. and Diane H. Steinberg Ambulatory Care Center
- DJL Clinical Research, PLLC
- Cape Fear Arthritis Care
- Paramount Medical Research & Consulting, LLC
- Health Research of Oklahoma
- Altoona Center For Clinical Research
- Piedmont Arthritis Clinic
- Tekton Research, Inc
- Accurate Clinical Management
- Metroplex Clinical Research Center
- Biopharma Informatic, LLC
- Accurate Clinical Management - Houston
- Biopharma Informatic, LLC
- Accurate Clinical Research
- Laila A Hassan, MD, PA
- Dynamed Clinical Research, LP d/b/a DM Clinical Research
- DM Clinical Research/Rheumatology Clinic of Houston
- Sound Clinical Research, LLC
- Arthritis Northwest, PLLC
- Rheumatology & Pulmonary Clinic
- Organizacion Medica de Investigacion
- Centro Privado de Medicina Familiar / Mindout Research
- APRILLUS Asistencia E Investigacion
- Clinica Adventista Belgrano
- Centro de Investigaciones Médicas Tucuman
- Centro de Investigaciones Reumatológicas
- Fundación Respirar
- Hospital Córdoba
- Instituto Medico Strusberg
- CER San Juan
- Aggarwal and Associates Limited
- Centre de Recherche Musculo-Squelettique
- G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
- The First Afflilated Hospital of Bengbu Medical College
- Peking University People's Hospital
- The First Affiliated Hospital, Sun Yat-sen University
- The First Affiliated Hospital of Shantou University Medical College
- ShenZhen People's Hospital
- Tongji Hospital Tongji Medical,Science & Technology
- Xiangya Hospital Central South University
- Jiangxi Pingxiang People's Hospital
- Huashan Hospital Affiliated Fudan University
- West China Hospital, Sichuan University
- General Hospital of Athens Hippokratio
- General Hospital of Athens Laiko
- Attikon General University Hospital
- University General Hospital of Heraklion
- University Hospital of Alexandroupolis
- Revita Clinic
- Vital Medical Center
- Qualiclinic
- IRCCS Ospedale Galeazzi - Sant'Ambrogio
- Azienda Ospedaliera Universitaria Careggi
- Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
- Chubu Rosai Hospital
- Koujunkai Daido Clinic
- Juntendo University Urayasu Hospital
- Shinkokura Hospital
- Tobata General Hospital
- University of Occupational and Enviromental Health
- Sagawa Akira Rheumatology Clinic
- Tonan Hospital
- Yoshida Internal Medicine Clinic
- Sasebo Chuo Hospital
- Nagaoka Red Cross Hospital
- Hirose Clinic - Tokorozawa
- Juntendo University Hospital
- National Hospital Organization Chibahigashi National Hospital
- Hiroshima Clinic
- Hiroshima University Hospital
- Bayside Misato Medical Center
- Shinonoi General Hospital
- Nagasaki Internal Medicine- Rheumatology Hospital
- Okayama City General Medical Center Okayama City Hospital
- Machida Municipal Hospital
- Centro Medico del Angel
- Clinstile, S.A. de C.V.
- Clinica de Investigacion en Reumatologia y Obesidad S. C.
- Kohler and Milstein Research S.A. de C.V.
- Investigacion y Biomedicina de Chihuahua
- Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej
- Twoja Przychodnia Centrum Medyczne Nowa Sol
- MICS Centrum Medyczne Warszawa
- Rheuma Medicus- Zak��ad Opieki Zdrowotnej
- Centrum Medyczne Reuma Park
- Nova Reuma Społka Partnerska
- Ambulatorium Barbara Bazela
- Ai Centrum Medyczne Sp. Z O.O. Sp.K.
- Twoja Przychodnia Poznanskie Centrum Medyczne
- Nzoz Bif-Med
- Centro Reumatologico Caguas
- Latin Clinical Trial Center
- GCM Medical Group, PSC - Hato Rey Site
- Mindful Medical Research
- CHUAC-Complejo Hospitalario Universitario A Coruña
- Clínica Gaias - Santiago
- Hospital Universitario Marqués de Valdecilla
- CHUS - Hospital Clinico Universitario
- Osi Bilbao-Basurto
- Hospital Quiron Infanta Luisa
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Peresolimab Dose 1
Peresolimab Dose 2
Peresolimab Dose 3
Placebo
Arm Description
Participants will be given peresolimab by subcutaneous injection.
Participants will be given peresolimab by subcutaneous injection.
Participants will be given peresolimab by subcutaneous injection.
Participants will be give placebo by subcutaneous injection.
Outcomes
Primary Outcome Measures
Percentage of Participants Achieving American College of Rheumatology (ACR)20
ACR20 - 20% improvement in the ACR core set values
Secondary Outcome Measures
Percentage of Participants Achieving ACR50 or ACR70
ACR50 - 50% improvement in the ACR core set values or ACR70 - 70% improvement in the ACR core set values
Percentage of Participants Achieving Low disease activity (LDA) or Remission in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP)
Percentage of Participants Achieving LDA or Remission in Clinical Disease Activity Index (CDAI)
Change from Baseline in DAS28-hsCRP
Change from Baseline in CDAI
Change from Baseline in Patient-Reported ACR Core Set Values in Patient's Assessment of Physical Function Using Health Assessment Questionnaire-Disability Index (HAQ-DI)
Pharmacokinetics (PK): Observed Trough Drug Concentration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05516758
Brief Title
A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis
Acronym
RESOLUTION-1
Official Title
A Phase 2b, Double-Blind, Placebo-Controlled Study to Evaluate Peresolimab in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 31, 2022 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
January 23, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to assess the safety and efficacy of peresolimab in adult participants with moderately-to-severely active rheumatoid arthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases, Connective Tissue Diseases, Autoimmune Diseases, Immune System Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
491 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peresolimab Dose 1
Arm Type
Experimental
Arm Description
Participants will be given peresolimab by subcutaneous injection.
Arm Title
Peresolimab Dose 2
Arm Type
Experimental
Arm Description
Participants will be given peresolimab by subcutaneous injection.
Arm Title
Peresolimab Dose 3
Arm Type
Experimental
Arm Description
Participants will be given peresolimab by subcutaneous injection.
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
Participants will be give placebo by subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
Peresolimab
Intervention Description
Administered subcutaneously (SC)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving American College of Rheumatology (ACR)20
Description
ACR20 - 20% improvement in the ACR core set values
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving ACR50 or ACR70
Description
ACR50 - 50% improvement in the ACR core set values or ACR70 - 70% improvement in the ACR core set values
Time Frame
Baseline to Week 12
Title
Percentage of Participants Achieving Low disease activity (LDA) or Remission in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP)
Time Frame
Week 12
Title
Percentage of Participants Achieving LDA or Remission in Clinical Disease Activity Index (CDAI)
Time Frame
Week 12
Title
Change from Baseline in DAS28-hsCRP
Time Frame
Baseline, Week 12
Title
Change from Baseline in CDAI
Time Frame
Baseline, Week 12
Title
Change from Baseline in Patient-Reported ACR Core Set Values in Patient's Assessment of Physical Function Using Health Assessment Questionnaire-Disability Index (HAQ-DI)
Time Frame
Baseline, Week 12
Title
Pharmacokinetics (PK): Observed Trough Drug Concentration
Time Frame
Baseline to Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of adult onset rheumatoid arthritis (RA) for at least 3 months prior to screening, as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria
Have moderately-to-severely active RA, at screening and baseline, defined by the presence of
≥6 swollen joints based on 66 joint count, and
≥6 tender joints based on 68 joint count.
Have had an inadequate response to, or loss of response or intolerance to at least 1 conventional synthetic DMARD (csDMARD), biologic DMARD ( bDMARD), or targeted synthetic DMARD (tsDMARD) treatment.
Exclusion Criteria:
Have Class IV RA according to ACR revised criteria.
Have presence of 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to
poorly controlled diabetes or hypertension
chronic kidney disease stage IIIb, IV, or V
symptomatic heart failure according to New York Heart Association Class II, III, or IV
myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, within the past 12 months before randomization
severe chronic pulmonary disease, for example, requiring oxygen therapy
major chronic inflammatory disease or connective tissue disease other than RA, including but not limited to,
systemic lupus erythematosus
psoriatic arthritis
axial spondyloarthritis including ankylosing spondylitis and non-radiographic axial spondyloarthritis
reactive arthritis
gout
scleroderma
polymyositis
dermatomyositis
active fibromyalgia, or
multiple sclerosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Accel Research Sites - Birmingham Clinical Research Unit
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research PLLC
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research, PLLC
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85037
Country
United States
Facility Name
Medvin Clinical Research - Metyas
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Facility Name
Providence Medical Foundation
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Christine Thai, MD
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Desert Medical Advances
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Wolverine Clinical Trials
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Dan La, MD Inc
City
Tujunga
State/Province
California
ZIP/Postal Code
91042
Country
United States
Facility Name
Medvin Clinical Research - Su
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Facility Name
Denver Arthritis Clinic
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Tekton Research - Fort Collins - East Harmony Road
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
HARAC Research Corp
City
Avon Park
State/Province
Florida
ZIP/Postal Code
33825
Country
United States
Facility Name
Encore Medical Research of Boynton Beach
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33436
Country
United States
Facility Name
Clinical Research of West Florida, Inc. (Clearwater)
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Suncoast Clinical Research, Inc.
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
West Broward Rheumatology Associates
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Clinical Research of West Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Baycare Medical Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Hinsdale Orthopaedics - llinois Bone & Joint Institute
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Accurate Clinical Research
City
Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70605
Country
United States
Facility Name
Great Lakes Research Group, Inc.
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Facility Name
AA Medical Research Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
Arthritis and Rheumatology Center of MI - Rochester Hills
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Saint Louis Rheumatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63119
Country
United States
Facility Name
Clinvest Headlands Llc
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Arthritis & Osteoporosis Associates - Freehold
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Facility Name
Albuquerque Center for Rheumatology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Joseph S. and Diane H. Steinberg Ambulatory Care Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
DJL Clinical Research, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Cape Fear Arthritis Care
City
Leland
State/Province
North Carolina
ZIP/Postal Code
28451
Country
United States
Facility Name
Paramount Medical Research & Consulting, LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Health Research of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Altoona Center For Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Piedmont Arthritis Clinic
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Tekton Research, Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Accurate Clinical Management
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Biopharma Informatic, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77043
Country
United States
Facility Name
Accurate Clinical Management - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Biopharma Informatic, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Accurate Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Laila A Hassan, MD, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Dynamed Clinical Research, LP d/b/a DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
DM Clinical Research/Rheumatology Clinic of Houston
City
Tomball
State/Province
Texas
ZIP/Postal Code
77377
Country
United States
Facility Name
Sound Clinical Research, LLC
City
Bothell
State/Province
Washington
ZIP/Postal Code
98021
Country
United States
Facility Name
Arthritis Northwest, PLLC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Rheumatology & Pulmonary Clinic
City
Beckley
State/Province
West Virginia
ZIP/Postal Code
25801
Country
United States
Facility Name
Organizacion Medica de Investigacion
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Centro Privado de Medicina Familiar / Mindout Research
City
Ciudad Autónoma de Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
1417
Country
Argentina
Facility Name
APRILLUS Asistencia E Investigacion
City
Caba
State/Province
Ciudad Aut
ZIP/Postal Code
1406
Country
Argentina
Facility Name
Clinica Adventista Belgrano
City
Caba
State/Province
Ciudad Autónoma De Buenos Aire
ZIP/Postal Code
C1430EGF
Country
Argentina
Facility Name
Centro de Investigaciones Médicas Tucuman
City
SAN M. DE Tucuman
State/Province
Tucumán
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Centro de Investigaciones Reumatológicas
City
San Miguel de Tucumán
State/Province
Tucumán
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Fundación Respirar
City
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Hospital Córdoba
City
Córdoba
ZIP/Postal Code
5004
Country
Argentina
Facility Name
Instituto Medico Strusberg
City
Córdoba
ZIP/Postal Code
X5000EDC
Country
Argentina
Facility Name
CER San Juan
City
San Juan
ZIP/Postal Code
5400
Country
Argentina
Facility Name
Aggarwal and Associates Limited
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Facility Name
Centre de Recherche Musculo-Squelettique
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
Facility Name
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
City
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
The First Afflilated Hospital of Bengbu Medical College
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
The First Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Facility Name
The First Affiliated Hospital of Shantou University Medical College
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515041
Country
China
Facility Name
ShenZhen People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Facility Name
Tongji Hospital Tongji Medical,Science & Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Jiangxi Pingxiang People's Hospital
City
Pingxiang
State/Province
Jiangxi
ZIP/Postal Code
337055
Country
China
Facility Name
Huashan Hospital Affiliated Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
West China Hospital, Sichuan University
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
General Hospital of Athens Hippokratio
City
Athens
State/Province
Attikí
ZIP/Postal Code
115 27
Country
Greece
Facility Name
General Hospital of Athens Laiko
City
Athens
State/Province
Attikí
ZIP/Postal Code
11527
Country
Greece
Facility Name
Attikon General University Hospital
City
Chaidari
State/Province
Attikí
ZIP/Postal Code
12462
Country
Greece
Facility Name
University General Hospital of Heraklion
City
Heraklion
State/Province
Krítí
ZIP/Postal Code
711 10
Country
Greece
Facility Name
University Hospital of Alexandroupolis
City
Alexanroupolis
State/Province
Évros
ZIP/Postal Code
68100
Country
Greece
Facility Name
Revita Clinic
City
Budapest
State/Province
Pest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Vital Medical Center
City
Veszprem
State/Province
Veszprém City
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Qualiclinic
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
IRCCS Ospedale Galeazzi - Sant'Ambrogio
City
Milan
State/Province
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Careggi
City
Firenze
ZIP/Postal Code
50141
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Chubu Rosai Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
455-8530
Country
Japan
Facility Name
Koujunkai Daido Clinic
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
Juntendo University Urayasu Hospital
City
Urayasu
State/Province
Chiba
ZIP/Postal Code
279-0021
Country
Japan
Facility Name
Shinkokura Hospital
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
803-0816
Country
Japan
Facility Name
Tobata General Hospital
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
804-0025
Country
Japan
Facility Name
University of Occupational and Enviromental Health
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
807-8556
Country
Japan
Facility Name
Sagawa Akira Rheumatology Clinic
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0001
Country
Japan
Facility Name
Tonan Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-0004
Country
Japan
Facility Name
Yoshida Internal Medicine Clinic
City
Sakaki
State/Province
Nagano
ZIP/Postal Code
389-0606
Country
Japan
Facility Name
Sasebo Chuo Hospital
City
Sasebo
State/Province
Nagasaki
ZIP/Postal Code
857-1195
Country
Japan
Facility Name
Nagaoka Red Cross Hospital
City
Nagaoka
State/Province
Niigata
ZIP/Postal Code
940-2108
Country
Japan
Facility Name
Hirose Clinic - Tokorozawa
City
Tokorozawa
State/Province
Saitama
ZIP/Postal Code
359-1111
Country
Japan
Facility Name
Juntendo University Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
National Hospital Organization Chibahigashi National Hospital
City
Chiba
ZIP/Postal Code
260-8712
Country
Japan
Facility Name
Hiroshima Clinic
City
Hiroshima
ZIP/Postal Code
733-0032
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Bayside Misato Medical Center
City
Kochi
ZIP/Postal Code
781-0112
Country
Japan
Facility Name
Shinonoi General Hospital
City
Nagano
ZIP/Postal Code
388-8004
Country
Japan
Facility Name
Nagasaki Internal Medicine- Rheumatology Hospital
City
Nagasaki
ZIP/Postal Code
850-0832
Country
Japan
Facility Name
Okayama City General Medical Center Okayama City Hospital
City
Okayama
ZIP/Postal Code
700-8557
Country
Japan
Facility Name
Machida Municipal Hospital
City
Tokyo
ZIP/Postal Code
194-0023
Country
Japan
Facility Name
Centro Medico del Angel
City
Mexicali
State/Province
Baja California
ZIP/Postal Code
21100
Country
Mexico
Facility Name
Clinstile, S.A. de C.V.
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Clinica de Investigacion en Reumatologia y Obesidad S. C.
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Kohler and Milstein Research S.A. de C.V.
City
Mérida
State/Province
Yucatán
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Investigacion y Biomedicina de Chihuahua
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Facility Name
Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Twoja Przychodnia Centrum Medyczne Nowa Sol
City
Nowa Sol
State/Province
Lubuskie
ZIP/Postal Code
67-100
Country
Poland
Facility Name
MICS Centrum Medyczne Warszawa
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
00-874
Country
Poland
Facility Name
Rheuma Medicus- Zak��ad Opieki Zdrowotnej
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-118
Country
Poland
Facility Name
Centrum Medyczne Reuma Park
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-665
Country
Poland
Facility Name
Nova Reuma Społka Partnerska
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-707
Country
Poland
Facility Name
Ambulatorium Barbara Bazela
City
Elbląg
State/Province
Warmińsko-mazurskie
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Ai Centrum Medyczne Sp. Z O.O. Sp.K.
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
61-113
Country
Poland
Facility Name
Twoja Przychodnia Poznanskie Centrum Medyczne
City
Poznań
State/Province
Wielkopolskie
ZIP/Postal Code
61-293
Country
Poland
Facility Name
Nzoz Bif-Med
City
Bytom
State/Province
Śląskie
ZIP/Postal Code
41-902
Country
Poland
Facility Name
Centro Reumatologico Caguas
City
Caguas
ZIP/Postal Code
00725
Country
Puerto Rico
Facility Name
Latin Clinical Trial Center
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
GCM Medical Group, PSC - Hato Rey Site
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
Facility Name
Mindful Medical Research
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
CHUAC-Complejo Hospitalario Universitario A Coruña
City
A Coruña
State/Province
A Coruña [La Coruña]
ZIP/Postal Code
15006
Country
Spain
Facility Name
Clínica Gaias - Santiago
City
Santiago de Compostela
State/Province
A Coruña [La Coruña]
ZIP/Postal Code
15702
Country
Spain
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Facility Name
CHUS - Hospital Clinico Universitario
City
Santiago de Compostela
State/Province
Galicia [Galicia]
ZIP/Postal Code
15706
Country
Spain
Facility Name
Osi Bilbao-Basurto
City
Bilbo
State/Province
País Vasco
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital Quiron Infanta Luisa
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement
IPD Sharing Time Frame
: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/
Links:
URL
https://trials.lilly.com/en-US/trial/356796
Description
A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis (RESOLUTION-1)
Learn more about this trial
A Study of Peresolimab (LY3462817) in Participants With Moderately-to-Severely Active Rheumatoid Arthritis
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