Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 18 to 75 Years of Age Treated With Subcutaneous (SC) Injections of ABBV-154 for Moderately to Severely Active Rheumatoid Arthritis (RA)

NCT ID: NCT04888585

Last Updated: 2024-10-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 473 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-23
• Study Completion Date: 2023-08-04

Brief Summary

Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. This study evaluated how safe and effective ABBV-154 is in participants treated for moderately to severely active RA. Adverse events and change in the disease activity were assessed.

ABBV-154 is an investigational drug being evaluated for the treatment of RA. Study doctors placed the participants in 1 of 5 treatment groups or arms; each arm received a different treatment. There was a 1 in 5 chance that participants were assigned to placebo. Participants 18-75 years of age with moderate to severe RA were enrolled. Around 425 participants were to be enrolled in the study at approximately 270 sites worldwide.

The study was comprised of a 12 week placebo-controlled period, a double-blind long term extension (LTE) period 1 of 66 weeks, a LTE period 2 of 104 weeks and a follow-up visit 70 days after the last dose of the study drug. In the LTE period 1, participants in the placebo group were re-randomized to receive ABBV-154 at 1 of 2 different doses SC every other week (EOW). Other participants remained on their previous dose and dosing regimen of ABBV-154.

There may have been a higher treatment burden for participants in this trial compared to their standard of care. Participants attended regular visits during the study at a hospital or clinic. The effect of the treatment was checked by medical assessments, blood tests, and side effects, and completing questionnaires.

Detailed Description

Participants were randomly assigned at a ratio of 1:1:1:1:1 to ABBV-154 at either 40 mg, 150 mg, 340 mg, subcutaneously (SC) EOW; 340 mg SC every 4 weeks (E4W); or placebo SC EOW. Randomization was stratified by baseline glucocorticoid (yes/no); number of prior failed biologic and/or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) (1; 2 or more); and prior anti-TNF failure (yes/no) and if yes, further stratification by prior adalimumab use (yes/no).

After 12 weeks, participants receiving placebo were re-randomized to receive ABBV-154 150 mg SC EOW or 340 mg SC EOW for the long-term extension (LTE) periods. At re-randomization, participants were stratified by baseline glucocorticoid use (yes/no) and prior adalimumab use (yes/no). Participants from the other dose groups were to continue with their respective dose and dosing regimen.

The primary analysis was conducted after all ongoing participants completed Week 12 or withdrew from the study. A final analysis was to be conducted after all participants completed LTE period 2 and a safety follow-up visit or withdrew from the study. The study was terminated before any participants entered LTE Period 2.

Conditions

Rheumatoid Arthritis (RA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Dose A of ABBV-154

Participants in this group will receive dose A of ABBV-154 subcutaneously (SC) every other week (eow) for 12 weeks in the placebo-controlled period, 66 weeks in the long term extension (LTE) period 1 and 104 weeks in LTE period 2.

Group Type: EXPERIMENTAL

ABBV-154

Intervention Type: DRUG

Subcutaneous Injection

Dose B of ABBV-154

Participants in this group will receive dose B of ABBV-154 SC eow for 12 weeks in the placebo-controlled period, 66 weeks in the LTE period 1 and 104 weeks in LTE period 2.

Group Type: EXPERIMENTAL

ABBV-154

Intervention Type: DRUG

Subcutaneous Injection

Dose C of ABBV-154 EOW

Participants in this group will receive dose C of ABBV-154 SC eow for 12 weeks in the placebo-controlled period, 66 weeks in the LTE period 1 and 104 weeks in LTE period 2.

Group Type: EXPERIMENTAL

ABBV-154

Intervention Type: DRUG

Subcutaneous Injection

Dose C of ABBV-154 E4W

Participants in this group will receive dose C of ABBV-154 SC every 4 weeks (e4w) for 12 weeks in the placebo-controlled period, 66 weeks in the LTE period 1 and 104 weeks in LTE period 2.

Group Type: EXPERIMENTAL

ABBV-154

Intervention Type: DRUG

Subcutaneous Injection

Placebo

Participants in this group will receive placebo SC eow for 12 weeks in the placebo-controlled period and will be re-randomized in 1:1 ratio to receive ABBV-154 dose B or C respectively SC eow for 66 weeks in the LTE period 1 and 104 weeks in LTE period 2.

Group Type: EXPERIMENTAL

ABBV-154

Intervention Type: DRUG

Subcutaneous Injection

Placebo

Intervention Type: DRUG

Subcutaneous Injection

Interventions

ABBV-154

Subcutaneous Injection

Intervention Type: DRUG

Placebo

Subcutaneous Injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of rheumatoid arthritis(RA) with fulfillment of the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA.
• Participant has >= 6 swollen joints (based on 66 joint count) and >=6 tender joints (based on 68 joint count) at baseline.
• Participant must have had an inadequate response to at least one prior biologic and/or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) treatment for RA.
• Participants must be on stable dose of methotrexate (MTX).

Exclusion Criteria

• Participant discontinued prior adalimumab therapy due to intolerability or toxicity.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Elite Clinical Studies, LLC /ID# 228227

Phoenix, Arizona, United States

Arthritis and Rheumatism Associates /ID# 228201

Jonesboro, Arkansas, United States

Providence Medical Foundation /ID# 228104

Fullerton, California, United States

Care Access Research, Huntington Beach /ID# 228163

Huntington Beach, California, United States

Purushotham & Akther Kotha MD, Inc /ID# 228120

La Mesa, California, United States

Arthritis & Osteo Medical Ctr /ID# 228239

La Palma, California, United States

Pacific Arthritis Care Center - Los Angeles /ID# 229330

Los Angeles, California, United States

California Medical Research Associates /ID# 230131

Northridge, California, United States

Arthritis Care And Research Center ACRC /ID# 230099

Poway, California, United States

East Bay Rheumatology Medical /ID# 228099

San Leandro, California, United States

Millennium Clinical Trials /ID# 230618

Thousand Oaks, California, United States

The Lundquist Institute at Harbor-UCLA Medical Center /ID# 228241

Torrance, California, United States

Medvin Clinical Research /ID# 228181

Tujunga, California, United States

Inland Rheum & Osteo Med Grp /ID# 228204

Upland, California, United States

Comprehensive Rheumatology Center /ID# 230132

Woodland Hills, California, United States

Denver Arthritis Clinic /ID# 228172

Denver, Colorado, United States

New England Research Associates, LLC /ID# 230127

Bridgeport, Connecticut, United States

Stamford Therapeutics Consorti /ID# 229214

Stamford, Connecticut, United States

Delaware Arthritis /ID# 229413

Lewes, Delaware, United States

Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 228229

Boca Raton, Florida, United States

Bay Area Arthritis and Osteo /ID# 228075

Brandon, Florida, United States

Clinical Research of West Florida, Inc /ID# 228128

Clearwater, Florida, United States

International Medical Research /ID# 228069

Daytona Beach, Florida, United States

Omega Research Debary, LLC /ID# 228293

DeBary, Florida, United States

Neoclinical Research /ID# 228753

Hialeah, Florida, United States

University of Florida /ID# 228242

Jacksonville, Florida, United States

Lakes Research, LLC /ID# 228665

Miami, Florida, United States

University of Miami /ID# 228737

Miami, Florida, United States

Suncoast Clinical Research /ID# 228237

New Port Richey, Florida, United States

Omega Research Group /ID# 229966

Orlando, Florida, United States

HMD Research LLC /ID# 228185

Orlando, Florida, United States

Millennium Research /ID# 228183

Ormond Beach, Florida, United States

Arthritis Center, Inc. /ID# 228209

Palm Harbor, Florida, United States

BayCare Medical Group /ID# 228289

St. Petersburg, Florida, United States

West Broward Rheumatology Associates /ID# 228603

Tamarac, Florida, United States

Clinical Research of West Florida - Tampa /ID# 228186

Tampa, Florida, United States

Conquest Research /ID# 230560

Winter Park, Florida, United States

Florida Medical Clinic /ID# 228236

Zephyrhills, Florida, United States

Arthritis and Rheumatology /ID# 228743

Atlanta, Georgia, United States

Jefrey D. Lieberman, MD, P.C. /ID# 230129

Decatur, Georgia, United States

Arthritis Center of North GA /ID# 228769

Gainesville, Georgia, United States

Atlanta Research Center for Rheumatology /ID# 230430

Marietta, Georgia, United States

Great Lakes Clinical Trials /ID# 228699

Chicago, Illinois, United States

Greater Chicago Specialty Physicians /ID# 228282

Schaumburg, Illinois, United States

Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 228174

Skokie, Illinois, United States

Springfield Clinic /ID# 228124

Springfield, Illinois, United States

Beacon Medical Group Clinical Research /ID# 229153

Granger, Indiana, United States

University of Iowa Hospitals and Clinics /ID# 229217

Iowa City, Iowa, United States

Four Rivers Clinical Research /ID# 230109

Paducah, Kentucky, United States

The Arthritis & Diabetes Clinic, Inc. /ID# 228221

Monroe, Louisiana, United States

Klein and Associates MD /ID# 230145

Cumberland, Maryland, United States

Klein and Associates MD - Hagerstown /ID# 230143

Hagerstown, Maryland, United States

The Center for Rheumatology and Bone Research /ID# 228617

Wheaton, Maryland, United States

AA Medical Research Center - Grand Blanc /ID# 228604

Grand Blanc, Michigan, United States

Advanced Rheumatology, PC /ID# 228684

Lansing, Michigan, United States

June DO, PC /ID# 229838

Lansing, Michigan, United States

Arthritis Associates /ID# 230188

Hattiesburg, Mississippi, United States

Rheumatology Consultants - Clinical Research /ID# 229208

Tupelo, Mississippi, United States

Clayton Medical Associates, P.C. dba Saint Louis Rheumatology /ID# 228283

St Louis, Missouri, United States

West County Rheumatology /ID# 228102

St Louis, Missouri, United States

Logan Health Research /ID# 228273

Kalispell, Montana, United States

Advanced Biomedical Research of America /ID# 228596

Las Vegas, Nevada, United States

Innovative Health Research /ID# 229209

Las Vegas, Nevada, United States

Arthritis and Osteoporosis Associates /ID# 229418

Freehold, New Jersey, United States

Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 228602

Voorhees Township, New Jersey, United States

Albuquerque Center For Rheumatology /ID# 228709

Albuquerque, New Mexico, United States

Albuquerque Clinical Trials, Inc /ID# 228925

Albuquerque, New Mexico, United States

Arthritis and Osteo Assoc /ID# 228662

Las Cruces, New Mexico, United States

Buffalo Rheumatology and Medicine - Orchard Park /ID# 228710

Orchard Park, New York, United States

St. Lawrence Health System /ID# 229508

Potsdam, New York, United States

DJL Clinical Research, PLLC /ID# 230133

Charlotte, North Carolina, United States

Cape Fear Arthritis Care /ID# 228747

Leland, North Carolina, United States

PMG Research of Salisbury /ID# 230627

Salisbury, North Carolina, United States

Trinity Health Med Arts Clinic /ID# 228202

Minot, North Dakota, United States

University of Cincinnati /ID# 229212

Cincinnati, Ohio, United States

Paramount Medical Research Con /ID# 228254

Middleburg Heights, Ohio, United States

Arthritis Assoc of NW Ohio /ID# 228936

Toledo, Ohio, United States

Arthritis and Rheumatology Center of Oklahoma /ID# 228975

Oklahoma City, Oklahoma, United States

Rheumatology Associates of Oklahoma /ID# 228701

Oklahoma City, Oklahoma, United States

Advanced Rheumatology & Arthritis Wellness Center /ID# 228608

Cranberry Township, Pennsylvania, United States

Altoona Ctr Clinical Res /ID# 230058

Duncansville, Pennsylvania, United States

Arthritis Group /ID# 229777

Philadelphia, Pennsylvania, United States

PA Regional Center for Arthritis and Osteoporosis Research /ID# 228742

Wyomissing, Pennsylvania, United States

Columbia Arthritis Center /ID# 228705

Columbia, South Carolina, United States

West Tennessee Research Institute /ID# 228257

Jackson, Tennessee, United States

Arthritis and Rheumatology Research Institute, PLLC /ID# 228937

Allen, Texas, United States

Allen Arthritis /ID# 228712

Allen, Texas, United States

Trinity Universal Research Associates - Carrollton /ID# 230104

Carrollton, Texas, United States

Adriana Pop-Moody MD Clinic PA /ID# 230062

Corpus Christi, Texas, United States

West Texas Clinical Research /ID# 228276

Lubbock, Texas, United States

P&I Clinical Research /ID# 230183

Lufkin, Texas, United States

SW Rheumatology Res. LLC /ID# 228088

Mesquite, Texas, United States

Trinity Universal Research Associates, Inc /ID# 228238

Plano, Texas, United States

Epic Medical Research /ID# 228097

Red Oak, Texas, United States

Sun Research Institute /ID# 228768

San Antonio, Texas, United States

Advanced Rheumatology of Houston /ID# 228170

The Woodlands, Texas, United States

DM Clinical Research - Tomball /ID# 228112

Tomball, Texas, United States

Rheumatology Clinic of Houston /ID# 228178

Tomball, Texas, United States

Arthritis & Osteoporosis Clinic /ID# 228736

Waco, Texas, United States

Tidewater Physicians Medical Center /ID# 230130

Newport News, Virginia, United States

Arthritis Northwest, PLLC /ID# 228275

Spokane, Washington, United States

Emeritus Research Sydney /ID# 230070

Botany, New South Wales, Australia

BJC Health /ID# 229015

Paramatta, New South Wales, Australia

Rheumatology Research Unit Sunshine Coast /ID# 229017

Maroochydore, Queensland, Australia

The Queen Elizabeth Hospital /ID# 230071

Woodville South, South Australia, Australia

Emeritus Research /ID# 229018

Camberwell, Victoria, Australia

Rheumatology Research Associates /ID# 227818

Edmonton, Alberta, Canada

Manitoba Clinic /ID# 227822

Winnipeg, Manitoba, Canada

Groupe de Recherche en Maladies Osseuses Inc /ID# 227821

Sainte-Foy, Quebec, Canada

Centre de Recherche Musculo-Squelettique /ID# 227824

Trois-Rivières, Quebec, Canada

Dr Naik-Medical Professional Corporation-Alliance Health /ID# 227823

Saskatoon, Saskatchewan, Canada

Revmatologicky ustav v Praze /ID# 229188

Prague, , Czechia

PV MEDICAL Services s.r.o. /ID# 228265

Prague, , Czechia

Revmatologicka ambulance - MUDr. Zuzana Urbanova /ID# 227775

Prague, , Czechia

Fakultni Nemocnice v Motole /ID# 231622

Prague, , Czechia

MEDICAL PLUS, s.r.o. /ID# 228030

Uherské Hradiště, , Czechia

RHEUMA s.r.o. /ID# 230850

Velké Bílovice, , Czechia

Rheumazentrum Ruhrgebiet /ID# 227850

Herne, North Rhine-Westphalia, Germany

Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 229526

Berlin, , Germany

MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 227785

Hamburg, , Germany

General Hospital of Athens Gennimatas /ID# 227806

Athens, Attica, Greece

University General Hospital of Heraklion PA.G.N.I /ID# 227804

Heraklion, Crete, Greece

424 General MILITARY Hospital /ID# 227805

Efkarpia (Thessalonikis), Thessaloniki, Greece

General Hospital of Thessaloniki Hippokrateio /ID# 229614

Thessaloniki, , Greece

Debreceni Egyetem Klinikai Kozpont /ID# 228371

Debrecen, Hajdú-Bihar, Hungary

Obudai Egeszsegugyi Centrum Kft. /ID# 228359

Budapest, Pest County, Hungary

DRC Gyogyszervizsgalo Kozpont Kft /ID# 228365

Balatonfüred, , Hungary

Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 227671

Budapest, , Hungary

Revita Reumatologiai Rendelo /ID# 227668

Budapest, , Hungary

CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 227670

Székesfehérvár, , Hungary

Vital Medical Center Orvosi es Fogaszati Kozpont (Vital Medicina Kft.) /ID# 227669

Veszprém, , Hungary

Obudai Egeszsegugyi Centrum Kft. Zalaegerszeg /ID# 228374

Zalaegerszeg, , Hungary

Meir Medical Center /ID# 226800

Kfar Saba, Central District, Israel

Rambam Health Care Campus /ID# 226798

Haifa, H_efa, Israel

Bnai Zion Medical Center /ID# 226801

Haifa, H_efa, Israel

The Lady Davis Carmel Medical Center /ID# 226802

Haifa, H_efa, Israel

The Chaim Sheba Medical Center /ID# 226797

Ramat Gan, Tel Aviv, Israel

Tel Aviv Sourasky Medical Center /ID# 228341

Tel Aviv, Tel Aviv, Israel

Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 228917

Rome, Lazio, Italy

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 228581

Ancona, , Italy

Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 228583

Palermo, , Italy

Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 229899

Nagoya, Aichi-ken, Japan

Daido Clinic /ID# 229280

Nagoya, Aichi-ken, Japan

Sugimoto rheumatology and internal medicine clinic /ID# 229495

Fukui-shi, Fukui, Japan

Hamanomachi Hospital /ID# 228644

Fukuoka, Fukuoka, Japan

National Hospital Organization Kyushu Medical Center /ID# 228642

Fukuoka, Fukuoka, Japan

Shono Rheumatism Clinic /ID# 229054

Fukuoka, Fukuoka, Japan

Katayama Orthopedic Rheumatology Clinic /ID# 229277

Asahikawa-shi, Hokkaido, Japan

Sagawa Akira Rheumatology Clin /ID# 228787

Sapporo, Hokkaido, Japan

Matsubara Mayflower Hospital /ID# 228948

Kato-shi, Hyōgo, Japan

Sanuki Municipal Hospital /ID# 229276

Sanuki-shi, Kagawa-ken, Japan

Bay Side Misato Medical Center /ID# 228947

Kochi, Kochi, Japan

Kumamoto Orthopaedic Hospital /ID# 228641

Kumamoto, Kumamoto, Japan

Medical Corporation Keiai Kai Clinic /ID# 228547

Miyazaki, Miyazaki, Japan

Sasebo Chuo Hospital /ID# 229168

Sasebo-shi, Nagasaki, Japan

Nagaoka Red Cross Hospital /ID# 229962

Nagaoka-shi, Niigata, Japan

National Hospital Organization Osaka Minami Medical Center /ID# 229174

Kawachinagano Shi, Osaka, Japan

Osaka City General Hospital /ID# 228786

Osaka, Osaka, Japan

Japanese Red Cross Osaka Hospital /ID# 229816

Osaka, Osaka, Japan

Azuma Rheumatology Clinic /ID# 230078

Sayama-shi, Saitama, Japan

St.Luke's International Hospital /ID# 229492

Chuo-ku, Tokyo, Japan

National Hospital Organization Tokyo Medical Center /ID# 228720

Meguro-ku, Tokyo, Japan

Medical Corporation Uchida Clinic /ID# 229494

Sumida-ku, Tokyo, Japan

Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 228354

Shimonoseki-shi, Yamaguchi, Japan

Academisch Medisch Centrum /ID# 227234

Amsterdam, , Netherlands

Maastricht Universitair Medisch Centrum /ID# 227235

Maastricht, , Netherlands

Aotearoa Clinical Trials /ID# 229012

Papatoetoe, Auckland, New Zealand

Timaru Medical Specialists Ltd /ID# 229013

Timaru, Canterbury, New Zealand

Wellington Regional Hospital /ID# 233517

Newtown, Wellington Region, New Zealand

Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 227939

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Centrum Medyczne Reuma Park /ID# 227170

Warsaw, Masovian Voivodeship, Poland

SANUS Szpital Specjalistyczny /ID# 227171

Stalowa Wola, Podkarpackie Voivodeship, Poland

ClinicMed Daniluk, Nowak Sp.k. /ID# 227919

Bialystok, Podlaskie Voivodeship, Poland

Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 228047

Gdansk, Pomeranian Voivodeship, Poland

MICS Centrum Medyczne Warszawa /ID# 231133

Warsaw, , Poland

AMICARE Sp. z o.o. sp.k. /ID# 231327

Lodz, Łódź Voivodeship, Poland

GCM Medical Group PSC /ID# 228981

San Juan, , Puerto Rico

Mindful Medical Research /ID# 228982

San Juan, , Puerto Rico

LLC Family Outpatient Clinic No /ID# 227926

Korolev, Moscow, Russia

Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 228755

Moscow, Moscow Oblast, Russia

Family Clinic /ID# 227929

Yekaterinburg, Sverdlovsk Oblast, Russia

Kazan State Medical University /ID# 227927

Kazan', Tatarstan, Respublika, Russia

Central Clinical Hospital of Russian Academy of Science /ID# 229438

Moscow, , Russia

Euromedservice /ID# 227933

Pushkin, , Russia

Clinical Rheumatologic Hospital No 25 /ID# 227922

Saint Petersburg, , Russia

MEDMAN s.r.o. /ID# 227826

Martin, , Slovakia

Reum.hapi s.r.o. /ID# 227825

Nové Mesto nad Váhom, , Slovakia

Thermium s.r.o. /ID# 227816

Piešťany, , Slovakia

REUMAMED POPRAD s.r.o. /ID# 229628

Poprad, , Slovakia

Reumex, s.r.o. /ID# 227827

Rimavská Sobota, , Slovakia

SoonChunHyang University CheonAn Hospital /ID# 228146

Cheonan-si, Chungcheongnam-do, South Korea

Yonsei University Health System Severance Hospital /ID# 227659

Seoul, Seoul Teugbyeolsi, South Korea

Hanyang University Seoul Hospital /ID# 227658

Seoul, Seoul Teugbyeolsi, South Korea

Kyungpook National University Hospital /ID# 227657

Daegu, , South Korea

Inha University Hospital /ID# 227656

Incheon, , South Korea

Asan Medical Center /ID# 227655

Seoul, , South Korea

Hospital Clínico Universitario de Santiago-CHUS /ID# 227420

Santiago de Compostela, A Coruna, Spain

Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 227666

Sabadell, Barcelona, Spain

Hospital Universitario Basurto /ID# 227667

Bilbao, Vizcaya, Spain

Hospital Universitario A Coruna - CHUAC /ID# 227419

A Coruña, , Spain

Hospital Universitario Fundacion Jimenez Diaz /ID# 234115

Madrid, , Spain

Hospital Universitario 12 de Octubre /ID# 227743

Madrid, , Spain

Hospital Regional Universitario de Malaga /ID# 227418

Málaga, , Spain

Hospital Universitario Virgen de Valme /ID# 227417

Seville, , Spain

Hospital Universitario y Politecnico La Fe /ID# 227408

Valencia, , Spain

Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 227220

Chiayi City, , Taiwan

Far Eastern Memorial Hospital /ID# 227373

New Taipei City, , Taiwan

National Taiwan University Hospital /ID# 230001

Taipei, , Taiwan

Taipei Veterans General Hosp /ID# 227376

Taipei, , Taiwan

Hacettepe Universitesi Tip Fak /ID# 227796

Sihhiye, Ankara, Turkey (Türkiye)

Ankara Univ Medical Faculty /ID# 227797

Ankara, , Turkey (Türkiye)

Kocaeli University Med Faculty /ID# 228244

Kocaeli, , Turkey (Türkiye)

MNI City Multidisciplinary Hospital #18 Kharkiv City Council /ID# 228961

Kharkiv, , Ukraine

Khmelnytskyi Regional Hospital /ID# 230680

Khmelnytskyi, , Ukraine

Medical Center of Medical Clinic Blagomed LLC /ID# 228956

Kyiv, , Ukraine

Medical Center "OK! Clinic+" LLC, "International Institute of Clinical Research" /ID# 228958

Kyiv, , Ukraine

Medical Center CONSILIUM MEDICAL /ID# 228959

Kyiv, , Ukraine

PI "Poltava Regional Clinical Hospital n.a. M.V.Sklifosovsky of PCC" /ID# 228962

Poltava, , Ukraine

CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 228954

Vinnytsia, , Ukraine

Сlinic Scientific Research Inst of Invalid Rehab ESMС M I Pyrogov VNMU /ID# 228955

Vinnytsia, , Ukraine

Countries

United States; Australia; Canada; Czechia; Germany; Greece; Hungary; Israel; Italy; Japan; Netherlands; New Zealand; Poland; Puerto Rico; Russia; Slovakia; South Korea; Spain; Taiwan; Turkey (Türkiye); Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-005303-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M20-466

Identifier Type: -

Identifier Source: org_study_id