Клинические исследование Rheumatoid Arthritis (RA): ABBV-154, Placebo - Реестр клинических исследований

Спонсоры	Ведущий спонсор: AbbVie
Источник	AbbVie
Краткое содержание	Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. This study evaluates how safe and effective ABBV-154 is in participants treated for moderately to severely active RA. Adverse events and change in the disease activity will be assessed. ABBV-154 is an investigational drug being evaluated for the treatment of RA. Study doctors place the participants in 1 of 5 treatment groups or arms, each arm receiving a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. Participants 18-75 years of age with moderate to severe RA will be enrolled. Around 425 participants will be enrolled in the study in approximately 270 sites worldwide. The study is compromised of a 12 week double-blind, placebo-controlled period, a double-blind long term extension (LTE) of 66 weeks, and a follow-up visit 70 days after the last dose of the study drug. In the LTE period, participants in the placebo group will be re-randomized to receive ABBV-154 in 2 different doses SC every other week (eow). Other participants will remain on their previous dose and dosing regimen of ABBV-154. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Общий статус

Recruiting

Дата начала

2021-06-02

Дата завершения

2024-05-10

Дата первичного завершения

2022-11-25

Фаза

Phase 2

Тип исследования

Interventional

Первичный результат

Мера	Временное ограничение
Percentage of Participants Achieving American College of Rheumatology 50 % (ACR50) Response	At 12 weeks

Вторичный результат

Мера	Временное ограничение
Change in Disease Activity Score (DAS) 28 (CRP) from Baseline	Up to 12 weeks
Change in Clinical Disease Activity Index (CDAI) from Baseline	Up to 12 weeks
Percentage of Participants Achieving American College of Rheumatology 20 % (ACR20) Response	At 12 weeks
Percentage of Participants Achieving American College of Rheumatology 70 % (ACR70) Response	At 12 weeks
Percentage of Participants Achieving Low Disease Activity (LDA) Defined by DAS28 (CRP) <= 3.2	At 12 weeks
Percentage of Participants Achieving LDA Defined by CDAI <= 10	At 12 weeks
Percentage of Participants Achieving Clinical Remission (CR) Defined by DAS28 (CRP) < 2.6	At 12 weeks
Percentage of Participants Achieving CR Defined by CDAI <= 2.8	At 12 weeks
Change in the Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline	Up to 12 weeks

Регистрация

425

Состояние	Rheumatoid Arthritis (RA)
Вмешательство	Тип вмешательства: Drug Название вмешательства: ABBV-154 Описание: Subcutaneous Injection Тип вмешательства: Drug Название вмешательства: Placebo Описание: Subcutaneous Injection Этикетка Arm Group: Placebo
Приемлемость	Критерии: Inclusion Criteria: - Clinical diagnosis of rheumatoid arthritis(RA) with fulfillment of the 2010 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. Пол: All Минимальный возраст: 18 Years Максимальный возраст: 75 Years Здоровые волонтеры: No

Состояние

Rheumatoid Arthritis (RA)

Вмешательство

Тип вмешательства: Drug

Название вмешательства: ABBV-154

Описание: Subcutaneous Injection

Тип вмешательства: Drug

Название вмешательства: Placebo

Описание: Subcutaneous Injection

Этикетка Arm Group: Placebo

Приемлемость

Критерии:

Inclusion Criteria: - Clinical diagnosis of rheumatoid arthritis(RA) with fulfillment of the 2010 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.

Пол:

All

Минимальный возраст:

18 Years

Максимальный возраст:

75 Years

Здоровые волонтеры:

Общий Официальный

Фамилия	Роль	Присоединение
ABBVIE INC.	Study Director	AbbVie

Общий контакт

Фамилия: ABBVIE CALL CENTER

Телефон: 844-663-3742

Расположение

Объект:	Положение дел:
Elite Clinical Studies, LLC /ID# 228227 \| Phoenix, Arizona, 85018, United States	Recruiting
Arthritis and Rheumatism Associates /ID# 228201 \| Jonesboro, Arkansas, 72401-6251, United States	Recruiting
Providence Medical Foundation /ID# 228104 \| Fullerton, California, 92835, United States	Not yet recruiting
Care Access Research, Huntington Beach /ID# 228163 \| Huntington Beach, California, 92648, United States	Recruiting
Private practice: San Diego Rheumatology /ID# 228120 \| La Mesa, California, 91942, United States	Recruiting
Arthritis & Osteo Medical Ctr /ID# 228239 \| La Palma, California, 90623-1728, United States	Recruiting
Pacific Arthritis Care Center - Los Angeles /ID# 229330 \| Los Angeles, California, 90045-6200, United States	Recruiting
University of California, Los Angeles /ID# 228161 \| Los Angeles, California, 90095, United States	Not yet recruiting
California Medical Research Associates /ID# 230131 \| Northridge, California, 91324, United States	Recruiting
Arthritis Care And Research Center ACRC /ID# 230099 \| Poway, California, 92064, United States	Recruiting
Univ California, San Francisco /ID# 228288 \| San Francisco, California, 94143-2204, United States	Not yet recruiting
East Bay Rheumatology Medical /ID# 228099 \| San Leandro, California, 94578, United States	Recruiting
Millennium Clinical Trials /ID# 230618 \| Thousand Oaks, California, 91360-3951, United States	Recruiting
The Lundquist Institute at Harbor-UCLA Medical Center /ID# 228241 \| Torrance, California, 90502, United States	Recruiting
Medvin Clinical Research /ID# 228181 \| Tujunga, California, 91042-2706, United States	Recruiting
Inland Rheum & Osteo Med Grp /ID# 228204 \| Upland, California, 91786, United States	Recruiting
Comprehensive Rheumatology Center /ID# 230132 \| West Hills, California, 91307-2003, United States	Recruiting
Denver Arthritis Clinic /ID# 228172 \| Denver, Colorado, 80230, United States	Recruiting
New England Research Associates, LLC /ID# 230127 \| Bridgeport, Connecticut, 06606-1827, United States	Recruiting
Stamford Therapeutics Consorti /ID# 229214 \| Stamford, Connecticut, 06905, United States	Recruiting
Delaware Arthritis /ID# 229413 \| Lewes, Delaware, 19958, United States	Recruiting
Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 228229 \| Boca Raton, Florida, 33486, United States	Recruiting
Bay Area Arthritis and Osteo /ID# 228075 \| Brandon, Florida, 33511, United States	Recruiting
Clinical Research of West Florida, Inc /ID# 228128 \| Clearwater, Florida, 33765, United States	Recruiting
International Medical Research - Daytona /ID# 228069 \| Daytona Beach, Florida, 32117, United States	Recruiting
Omega Research Debary, LLC /ID# 228293 \| DeBary, Florida, 32713-2260, United States	Recruiting
Sweet Hope Research Specialty Inc /ID# 228753 \| Hialeah, Florida, 33016-1897, United States	Not yet recruiting
University of Florida /ID# 228242 \| Jacksonville, Florida, 32209, United States	Recruiting
Lakes Research, LLC /ID# 228665 \| Miami, Florida, 33014, United States	Recruiting
University of Miami /ID# 228737 \| Miami, Florida, 33136, United States	Not yet recruiting
Suncoast Clinical Research /ID# 228237 \| New Port Richey, Florida, 34652, United States	Recruiting
HMD Research LLC /ID# 228185 \| Orlando, Florida, 32819, United States	Recruiting
Omega Research MetroWest, LLC /ID# 229966 \| Orlando, Florida, 32835-7620, United States	Recruiting
Millennium Research /ID# 228183 \| Ormond Beach, Florida, 32174, United States	Recruiting
Arthritis Center, Inc. /ID# 228209 \| Palm Harbor, Florida, 34684, United States	Recruiting
BayCare Medical Group Rheumatology - St Petersburg /ID# 228289 \| Saint Petersburg, Florida, 33710-1536, United States	Recruiting
West Broward Rheumatology Associates /ID# 228603 \| Tamarac, Florida, 33321, United States	Recruiting
Clinical Research of West Florida - Tampa /ID# 228186 \| Tampa, Florida, 33606-1246, United States	Recruiting
USF Health Division of Rheumat /ID# 228286 \| Tampa, Florida, 33612, United States	Not yet recruiting
Conquest Research /ID# 230560 \| Winter Park, Florida, 32789, United States	Recruiting
Florida Medical Clinic /ID# 228236 \| Zephyrhills, Florida, 33542, United States	Recruiting
Arthritis and Rheumatology /ID# 228743 \| Atlanta, Georgia, 30342, United States	Recruiting
Jefrey D. Lieberman, MD, P.C. /ID# 230129 \| Decatur, Georgia, 30033, United States	Not yet recruiting
Arthritis Center of North GA /ID# 228769 \| Gainesville, Georgia, 30501, United States	Recruiting
Atlanta Research Center for Rheumatology /ID# 230430 \| Marietta, Georgia, 20060, United States	Recruiting
Great Lakes Clinical Trials /ID# 228699 \| Chicago, Illinois, 60640, United States	Recruiting
Greater Chicago Specialty Physicians /ID# 228282 \| Schaumburg, Illinois, 60195-3106, United States	Recruiting
Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 228174 \| Skokie, Illinois, 60076, United States	Recruiting
Springfield Clinic /ID# 228124 \| Springfield, Illinois, 62702-3749, United States	Recruiting
Beacon Medical Group Clinical Research /ID# 229153 \| Granger, Indiana, 46530, United States	Recruiting
University of Iowa Hospitals and Clinics /ID# 229217 \| Iowa City, Iowa, 52242, United States	Not yet recruiting
Four Rivers Clinical Research /ID# 230109 \| Paducah, Kentucky, 42001, United States	Recruiting
Ochsner Clinic Foundation /ID# 228101 \| Baton Rouge, Louisiana, 70836-6455, United States	Not yet recruiting
The Arthritis & Diabetes Clinic, Inc. /ID# 228221 \| Monroe, Louisiana, 71203, United States	Recruiting
Klein and Associates MD /ID# 230145 \| Hagerstown, Maryland, 21740, United States	Recruiting
Klein and Associates MD - Hagerstown /ID# 230143 \| Hagerstown, Maryland, 21742, United States	Recruiting
The Center for Rheumatology and Bone Research /ID# 228617 \| Wheaton, Maryland, 20902, United States	Recruiting
AA Medical Research Center /ID# 228604 \| Grand Blanc, Michigan, 48439, United States	Recruiting
Advanced Rheumatology, PC /ID# 228684 \| Lansing, Michigan, 48910, United States	Recruiting
June DO, PC /ID# 229838 \| Lansing, Michigan, 48910, United States	Recruiting
Arthritis Associates /ID# 230188 \| Hattiesburg, Mississippi, 39402, United States	Recruiting
Rheumatology Consultants - Clinical Research /ID# 229208 \| Tupelo, Mississippi, 38801-4949, United States	Not yet recruiting
Clayton Medical Associates, P.C. dba Saint Louis Rheumatology /ID# 228283 \| Saint Louis, Missouri, 63119-3845, United States	Recruiting
West County Rheumatology /ID# 228102 \| Saint Louis, Missouri, 63131-1703, United States	Recruiting
Logan Health Research /ID# 228273 \| Kalispell, Montana, 59901, United States	Recruiting
Advanced Biomedical Research of America /ID# 228596 \| Las Vegas, Nevada, 89123, United States	Recruiting
Innovative Health Research /ID# 229209 \| Las Vegas, Nevada, 89128, United States	Recruiting
Dartmouth-Hitchcock Medical Center /ID# 228589 \| Lebanon, New Hampshire, 03756, United States	Not yet recruiting
Arthritis and Osteoporosis Associates /ID# 229418 \| Freehold, New Jersey, 07728-8307, United States	Recruiting
Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 228602 \| Voorhees, New Jersey, 08043, United States	Recruiting
Albuquerque Center For Rheumatology /ID# 228709 \| Albuquerque, New Mexico, 87102, United States	Recruiting
Albuquerque Clinical Trials, Inc /ID# 228925 \| Albuquerque, New Mexico, 87102, United States	Recruiting
Arthritis and Osteo Assoc /ID# 228662 \| Las Cruces, New Mexico, 88011, United States	Recruiting
Buffalo Rheumatology and Medicine - Orchard Park /ID# 228710 \| Orchard Park, New York, 14127, United States	Recruiting
St. Lawrence Health System /ID# 229508 \| Potsdam, New York, 13676, United States	Recruiting
DJL Clinical Research, PLLC /ID# 230133 \| Charlotte, North Carolina, 28210-8508, United States	Recruiting
Cape Fear Arthritis Care /ID# 228747 \| Leland, North Carolina, 28451, United States	Recruiting
PMG Research of Salisbury /ID# 230627 \| Salisbury, North Carolina, 28144, United States	Recruiting
Trinity Health Med Arts Clinic /ID# 228202 \| Minot, North Dakota, 58701, United States	Recruiting
University of Cincinnati /ID# 229212 \| Cincinnati, Ohio, 45267-0585, United States	Recruiting
Paramount Medical Research Con /ID# 228254 \| Middleburg Heights, Ohio, 44130, United States	Recruiting
Arthritis Assoc of NW Ohio /ID# 228936 \| Toledo, Ohio, 43606, United States	Recruiting
Arthritis and Rheumatology Center of Oklahoma /ID# 228975 \| Oklahoma City, Oklahoma, 73102, United States	Recruiting
Rheumatology Associates of Oklahoma /ID# 228701 \| Oklahoma City, Oklahoma, 73116-7226, United States	Active, not recruiting
Advanced Rheumatology & Arthritis Wellness Center /ID# 228608 \| Cranberry Township, Pennsylvania, 16066, United States	Recruiting
Altoona Ctr Clinical Res /ID# 230058 \| Duncansville, Pennsylvania, 16635, United States	Recruiting
Arthritis Group /ID# 229777 \| Philadelphia, Pennsylvania, 19152, United States	Recruiting
PA Regional Center for Arthritis and Osteoporosis Research /ID# 228742 \| Wyomissing, Pennsylvania, 19610, United States	Recruiting
Columbia Arthritis Center /ID# 228705 \| Columbia, South Carolina, 29204, United States	Recruiting
West Tennessee Research Institute /ID# 228257 \| Jackson, Tennessee, 38305, United States	Recruiting
Arthritis and Rheumatology Research Institute, PLLC /ID# 228937 \| Allen, Texas, 75013-6147, United States	Recruiting
Allen Arthritis /ID# 228712 \| Allen, Texas, 75013, United States	Recruiting
Trinity Universal Research Associates - Carrollton /ID# 230104 \| Carrollton, Texas, 75007, United States	Recruiting
Adriana Pop-Moody MD Clinic PA /ID# 230062 \| Corpus Christi, Texas, 78404, United States	Not yet recruiting
Rheumatology Clinic of Houston /ID# 228178 \| Houston, Texas, 77065, United States	Recruiting
West Texas Clinical Research /ID# 228276 \| Lubbock, Texas, 79410-1198, United States	Recruiting
P&I Clinical Research /ID# 230183 \| Lufkin, Texas, 75904-3132, United States	Recruiting
SW Rheumatology Res. LLC /ID# 228088 \| Mesquite, Texas, 75150, United States	Recruiting
Trinity Universal Research Associates, Inc /ID# 228238 \| Plano, Texas, 75024-5283, United States	Recruiting
Epic Medical Research /ID# 228097 \| Red Oak, Texas, 75154-3981, United States	Recruiting
Sun Research Institute /ID# 228768 \| San Antonio, Texas, 78215, United States	Recruiting
Advanced Rheumatology of Houston /ID# 228170 \| The Woodlands, Texas, 77382, United States	Recruiting
DM Clinical Research /ID# 228112 \| Tomball, Texas, 77375, United States	Recruiting
Arthritis & Osteoporosis Clinic /ID# 228736 \| Waco, Texas, 76710, United States	Recruiting
Tidewater Physicians Medical Center /ID# 230130 \| Newport News, Virginia, 23606-4434, United States	Recruiting
Arthritis Northwest, PLLC /ID# 228275 \| Spokane, Washington, 99204-2302, United States	Recruiting
Emeritus Research Sydney /ID# 230070 \| Botany, New South Wales, 2019, Australia	Not yet recruiting
BJC Health /ID# 229015 \| Paramatta, New South Wales, 2150, Australia	Not yet recruiting
Rheumatology Research Unit Sunshine Coast /ID# 229017 \| Maroochydore, Queensland, 4558, Australia	Not yet recruiting
The Queen Elizabeth Hospital /ID# 230071 \| Woodville South, South Australia, 5011, Australia	Not yet recruiting
Emeritus Research /ID# 229018 \| Camberwell, Victoria, 3124, Australia	Not yet recruiting
Rheumatology Research Associates /ID# 227818 \| Edmonton, Alberta, T5M 0H4, Canada	Recruiting
Manitoba Clinic /ID# 227822 \| Winnipeg, Manitoba, R3A 1M3, Canada	Recruiting
Groupe de Recherche en Maladies Osseuses Inc /ID# 227821 \| Sainte-foy, Quebec, G1V 3M7, Canada	Recruiting
Centre de Recherche Musculo-Squelettique /ID# 227824 \| Trois-rivières, Quebec, G8Z 1Y2, Canada	Recruiting
Dr. Latha Naik /ID# 227823 \| Saskatoon, Saskatchewan, S7K 3H3, Canada	Recruiting
Revmatologicky ustav v Praze /ID# 229188 \| Praha, 128 00, Czechia	Recruiting
PV MEDICAL Services s.r.o. /ID# 228265 \| Praha, 130 00, Czechia	Not yet recruiting
Revmatologicka ambulance - MUDr. Zuzana Urbanova /ID# 227775 \| Praha, 140 00, Czechia	Recruiting
Fakultni Nemocnice v Motole /ID# 231622 \| Praha, 150 06, Czechia	Not yet recruiting
MEDICAL PLUS, s.r.o. /ID# 228030 \| Uherske Hradiste, 686 01, Czechia	Recruiting
RHEUMA s.r.o. /ID# 230850 \| Velke Bilovice, 691 02, Czechia	Not yet recruiting
Rheumazentrum Ruhrgebiet /ID# 227850 \| Herne, Nordrhein-Westfalen, 44649, Germany	Recruiting
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 229526 \| Berlin, 10117, Germany	Not yet recruiting
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 227785 \| Hamburg, 20095, Germany	Not yet recruiting
General Hospital of Athens Gennimatas /ID# 227806 \| Athens, Attiki, 11527, Greece	Not yet recruiting
University General Hospital of Heraklion PA.G.N.I /ID# 227804 \| Heraklion, Kriti, 71500, Greece	Not yet recruiting
424 General MILITARY Hospital /ID# 227805 \| Efkarpia (Thessalonikis), Thessaloniki, 56429, Greece	Not yet recruiting
General Hospital of Thessaloniki Hippokrateio /ID# 229614 \| Thessaloniki, 54642, Greece	Not yet recruiting
Debreceni Egyetem Klinikai Kozpont /ID# 228371 \| Debrecen, Hajdu-Bihar, 4032, Hungary	Recruiting
Obudai Egeszsegugyi Centrum Kft. /ID# 228359 \| Budapest, Pest, 1036, Hungary	Recruiting
DRC Gyogyszervizsgalo Kozpont Kft /ID# 228365 \| Balatonfüred, 8230, Hungary	Recruiting
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 227671 \| Budapest, 1023, Hungary	Recruiting
Revita Reumatologiai Rendelo /ID# 227668 \| Budapest, 1027, Hungary	Recruiting
CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 227670 \| Szekesfehervar, 8000, Hungary	Recruiting
Vital Medical Center Orvosi es Fogaszati Kozpont (Vital Medicina Kft.) /ID# 227669 \| Veszprém, 8200, Hungary	Recruiting
Obudai Egeszsegugyi Centrum Kft. Zalaegerszeg /ID# 228374 \| Zalaegerszeg, 8900, Hungary	Recruiting
The Chaim Sheba Medical Center /ID# 226797 \| Ramat Gan, Tel-Aviv, 5265601, Israel	Recruiting
Tel Aviv Sourasky Medical Center /ID# 228341 \| Tel Aviv-Yafo, Tel-Aviv, 6423906, Israel	Recruiting
Rambam Health Care Campus /ID# 226798 \| Haifa, 3109601, Israel	Recruiting
Bnai Zion Medical Center /ID# 226801 \| Haifa, 3339419, Israel	Not yet recruiting
The Lady Davis Carmel Medical Center /ID# 226802 \| Haifa, 34362, Israel	Not yet recruiting
Meir Medical Center /ID# 226800 \| Kfar Saba, 4428164, Israel	Recruiting
Policlinico Universitario Campus Bio-Medico /ID# 228917 \| Rome, Lazio, 00128, Italy	Recruiting
Ospedale San Raffaele IRCCS /ID# 228582 \| Milan, Lombardia, 20132, Italy	Not yet recruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 228581 \| Ancona, 60126, Italy	Not yet recruiting
Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 228583 \| Palermo, 90127, Italy	Not yet recruiting
Azienda USL di Reggio Emilia-IRCCS-Arcispedale Santa Maria Nuova /ID# 228734 \| Reggio Emilia, 42121, Italy	Not yet recruiting
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 229899 \| Nagoya-shi, Aichi, 455-8530, Japan	Recruiting
Daido Clinic /ID# 229280 \| Nagoya-shi, Aichi, 457-8511, Japan	Recruiting
Sugimoto rheumatology and internal medicine clinic /ID# 229495 \| Fukui-shi, Fukui, 910-0068, Japan	Recruiting
National Hospital Organization Kyushu Medical Center /ID# 228642 \| Fukuoka shi, Fukuoka, 810-8563, Japan	Recruiting
Hamanomachi Hospital /ID# 228644 \| Fukuoka-shi, Fukuoka, 810-8539, Japan	Recruiting
Shono Rheumatism Clinic /ID# 229054 \| Fukuoka-shi, Fukuoka, 814-0002, Japan	Recruiting
Katayama Orthopedic Rheumatology Clinic /ID# 229277 \| Asahikawa-shi, Hokkaido, 078-8243, Japan	Recruiting
Sagawa Akira Rheumatology Clin /ID# 228787 \| Sapporo-shi, Hokkaido, 060-0001, Japan	Recruiting
Matsubara Mayflower Hospital /ID# 228948 \| Kato-shi, Hyogo, 673-1462, Japan	Recruiting
Sanuki Municipal Hospital /ID# 229276 \| Sanuki-shi, Kagawa, 769-2393, Japan	Recruiting
Bay Side Misato Medical Center /ID# 228947 \| Kochi-shi, Kochi, 781-0112, Japan	Recruiting
Kumamoto Orthopaedic Hospital /ID# 228641 \| Kumamoto shi, Kumamoto, 8620975, Japan	Recruiting
Medical Corporation Keiai Kai Clinic /ID# 228547 \| Miyazaki-shi, Miyazaki, 880-0053, Japan	Recruiting
Sasebo Chuo Hospital /ID# 229168 \| Sasebo-shi, Nagasaki, 857-1195, Japan	Recruiting
Nagaoka Red Cross Hospital /ID# 229962 \| Nagaoka-shi, Niigata, 940-2085, Japan	Recruiting
National Hospital Organization Osaka Minami Medical Center /ID# 229174 \| Kawachinagano Shi, Osaka, 586-8521, Japan	Recruiting
Osaka City General Hospital /ID# 228786 \| Osaka-shi, Osaka, 534-0021, Japan	Recruiting
Japanese Red Cross Osaka Hospital /ID# 229816 \| Osaka-shi, Osaka, 543-8555, Japan	Recruiting
Azuma Rheumatology Clinic /ID# 230078 \| Sayama-shi, Saitama, 350-1305, Japan	Recruiting
St.Luke's International Hospital /ID# 229492 \| Chuo-ku, Tokyo, 104-8560, Japan	Recruiting
National Hospital Organization Tokyo Medical Center /ID# 228720 \| Meguro-ku, Tokyo, 152-8902, Japan	Recruiting
Medical Corporation Uchida Clinic /ID# 229494 \| Sumida-ku, Tokyo, 130-0013, Japan	Recruiting
Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 228354 \| Shimonoseki-shi, Yamaguchi, 752-0976, Japan	Recruiting
SoonChunHyang University CheonAn Hospital /ID# 228146 \| Cheonan-si, Chungcheongnamdo, 31151, Korea, Republic of	Not yet recruiting
Yonsei University Health System Severance Hospital /ID# 227659 \| Seoul, Seoul Teugbyeolsi, 03722, Korea, Republic of	Not yet recruiting
Hanyang University Seoul Hospital /ID# 227658 \| Seoul, Seoul Teugbyeolsi, 04763, Korea, Republic of	Not yet recruiting
Kyungpook National University Hospital /ID# 227657 \| Daegu, 41944, Korea, Republic of	Not yet recruiting
Inha University Hospital /ID# 227656 \| Incheon, 22332, Korea, Republic of	Not yet recruiting
Asan Medical Center /ID# 227655 \| Seoul, 05505, Korea, Republic of	Not yet recruiting
ZiekenhuisGroep Twente /ID# 229072 \| Almelo, 7609 PP, Netherlands	Not yet recruiting
Academisch Medisch Centrum /ID# 227234 \| Amsterdam, 1105 AZ, Netherlands	Not yet recruiting
Maastricht Universitair Medisch Centrum /ID# 227235 \| Maastricht, 6229 HX, Netherlands	Not yet recruiting
Middlemore Clinical Trials /ID# 229012 \| Papatoetoe, Auckland, 2025, New Zealand	Not yet recruiting
Timaru Medical Specialists Ltd /ID# 229013 \| Timaru, Canterbury, 7910, New Zealand	Not yet recruiting
Waikato Hospital /ID# 229011 \| Hamilton, Waikato, 3240, New Zealand	Not yet recruiting
Wellington Regional Hospital /ID# 233517 \| Newtown, Wellington, 6021, New Zealand	Not yet recruiting
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 227939 \| Bydgoszcz, Kujawsko-pomorskie, 85-168, Poland	Not yet recruiting
AMICARE Sp. z o.o. sp.k. /ID# 231327 \| Lodz, Lodzkie, 90-644, Poland	Recruiting
Duplicate_Centrum Medyczne Reuma Park /ID# 227170 \| Warszawa, Mazowieckie, 02-691, Poland	Not yet recruiting
SANUS Szpital Specjalistyczny /ID# 227171 \| Stalowa Wola, Podkarpackie, 37-450, Poland	Not yet recruiting
ClinicMed Daniluk, Nowak Sp.j. /ID# 227919 \| Bialystok, Podlaskie, 15-879, Poland	Not yet recruiting
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 228047 \| Gdansk, Pomorskie, 80-546, Poland	Not yet recruiting
Medycyna Kliniczna /ID# 231133 \| Warsaw, 00-874, Poland	Not yet recruiting
GCM Medical Group PSC - Hato Rey /ID# 228981 \| San Juan, 00917-3104, Puerto Rico	Recruiting
Mindful Medical Research /ID# 228982 \| San Juan, 00918-3756, Puerto Rico	Recruiting
Immanuel Kant Baltic Federal University /ID# 228157 \| Kaliningrad, Kaliningradskaya Oblast, 236016, Russian Federation	Not yet recruiting
Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 228755 \| Moscow, Moskovskaya Oblast, 129110, Russian Federation	Recruiting
LLC Family Outpatient Clinic № /ID# 227926 \| Korolev, Moskva, 141060, Russian Federation	Recruiting
Perm Clinical Center of the Federal Medical and Biological Agency /ID# 227932 \| Perm, Permskiy Kray, 614109, Russian Federation	Not yet recruiting
Nort-Western State Medical University n.a. Mechnikov /ID# 230300 \| St. Petersburg, Sankt-Peterburg, 193015, Russian Federation	Not yet recruiting
Family Clinic /ID# 227929 \| Yekaterinburg, Sverdlovskaya Oblast, 620109, Russian Federation	Not yet recruiting
Kazan State Medical University /ID# 227927 \| Kazan, Tatarstan, Respublika, 420012, Russian Federation	Recruiting
Central Clinical Hospital of Russian Academy of Science /ID# 229438 \| Moscow, 117593, Russian Federation	Not yet recruiting
Euromedservice /ID# 227933 \| Pushkin, 196603, Russian Federation	Not yet recruiting
Clinical Rheumatologic Hospital No 25 /ID# 227922 \| St. Petersburg, 190068, Russian Federation	Not yet recruiting
MEDMAN s.r.o. /ID# 227826 \| Martin, 036 01, Slovakia	Recruiting
Reum.hapi s.r.o. /ID# 227825 \| Nove Mesto nad Vahom, 915 01, Slovakia	Not yet recruiting
Thermium s.r.o. /ID# 227816 \| Piestany, 921 01, Slovakia	Not yet recruiting
REUMAMED POPRAD s.r.o. /ID# 229628 \| Poprad, 058 01, Slovakia	Recruiting
Reumex, s.r.o. /ID# 227827 \| Rimavska Sobota, 979 01, Slovakia	Recruiting
Hospital Clínico Universitario de Santiago-CHUS /ID# 227420 \| Santiago de Compostela, A Coruna, 15706, Spain	Recruiting
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 227666 \| Sabadell, Barcelona, 08208, Spain	Recruiting
Hospital Regional de Malaga /ID# 227418 \| Málaga, Malaga, 29010, Spain	Recruiting
Hospital Universitario Basurto /ID# 227667 \| Bilbao, Vizcaya, 48013, Spain	Recruiting
Hospital Universitario A Coruna - CHUAC /ID# 227419 \| A Coruna, 15006, Spain	Recruiting
Hospital Universitario Fundacion Jimenez Diaz /ID# 234115 \| Madrid, 28040, Spain	Recruiting
Hospital Universitario 12 de Octubre /ID# 227743 \| Madrid, 28041, Spain	Recruiting
Hospital Universitario Virgen de Valme /ID# 227417 \| Sevilla, 41014, Spain	Recruiting
Hospital Universitario y Politecnico La Fe /ID# 227408 \| Valencia, 46026, Spain	Recruiting
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 227220 \| Chia-Yi, 62247, Taiwan	Recruiting
Far Eastern Memorial Hospital /ID# 227373 \| New Taipei City, 22060, Taiwan	Recruiting
National Taiwan University Hospital /ID# 230001 \| Taipei City, 100, Taiwan	Recruiting
Taipei Veterans General Hosp /ID# 227376 \| Taipei City, 11217, Taiwan	Recruiting
Hacettepe Universitesi Tip Fak /ID# 227796 \| Sihhiye, Ankara, 06100, Turkey	Not yet recruiting
Ankara Univ Medical Faculty /ID# 227797 \| Ankara, 06590, Turkey	Not yet recruiting
Akdeniz Universitesi Tip Fakul /ID# 228040 \| Antalya, 07059, Turkey	Not yet recruiting
Istanbul University Cerrahpasa Faculty of Medicine /ID# 227795 \| Cerrahpasa, 34098, Turkey	Not yet recruiting
Kocaeli University Med Faculty /ID# 228244 \| Kocaeli, 41380, Turkey	Not yet recruiting
State Institution L. T. Malaya Therapy National Institution of NAMS of Ukraine /ID# 228960 \| Kharkiv, Kharkivska Oblast, 61039, Ukraine	Not yet recruiting
Scientific Research Institute of Invalid Rehabilitation /ID# 228955 \| Vinnytsia, Vinnytska Oblast, 21029, Ukraine	Not yet recruiting
PNE City Multifunctional Hospital No.18 /ID# 228961 \| Kharkiv, 61029, Ukraine	Not yet recruiting
Khmelnytskyi Regional Hospital /ID# 230680 \| Khmelnytskyi, 29000, Ukraine	Not yet recruiting
Medical Centre of Medical Clinic Blagomed LLC /ID# 228956 \| Kyiv, 01601, Ukraine	Not yet recruiting
Medical Center OK Clinic /ID# 228958 \| Kyiv, 02091, Ukraine	Not yet recruiting
Medical centre of CONSILIUM MEDICAL LLC /ID# 228959 \| Kyiv, 04050, Ukraine	Not yet recruiting
PI "Poltava Regional Clinical Hospital n.a. M.V.Sklifosovsky" /ID# 228962 \| Poltava, 36011, Ukraine	Not yet recruiting
MNPE Vinnytsia Regional Clinical Hospital n.a. M.I. Pyrohov /ID# 228954 \| Vinnytsia, 21028, Ukraine	Not yet recruiting
Public Institution 6th City Clinical Hospital /ID# 228964 \| Zaporizhzhia, 69035, Ukraine	Not yet recruiting
Lancashire and South Cumbria NHS Foundation Trust /ID# 238668 \| Preston, Lancashire, PR1 6SB, United Kingdom	Not yet recruiting
The Royal Free London NHS Foundation Trust /ID# 232082 \| London, London, City Of, NW3 2QG, United Kingdom	Not yet recruiting
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 238727 \| Norwich, Norfolk, NR4 7UY, United Kingdom	Not yet recruiting
Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust /ID# 239926 \| Armthorpe Road, DN2 5LT, United Kingdom	Not yet recruiting
Queen Mary University of London /ID# 232185 \| London, EC1M 6BQ, United Kingdom	Not yet recruiting
Aneurin Bevan University Health Board /ID# 240393 \| Newport, NP19 7PH, United Kingdom	Not yet recruiting
The Royal Wolverhampton NHS Trust /ID# 238489 \| Wolverhampton, WV10 0QP, United Kingdom	Not yet recruiting

Расположение Страны	Australia Canada Czechia Germany Greece Hungary Israel Italy Japan Korea, Republic of Netherlands New Zealand Poland Puerto Rico Russian Federation Slovakia Spain Taiwan Turkey Ukraine United Kingdom United States
Дата проверки	2022-01-01
Ответственная сторона	Тип: Sponsor
Ключевые слова	Rheumatoid Arthritis (RA) ABBV-154
Имеет расширенный доступ	No
Состояние Просмотр	Arthritis Arthritis, Rheumatoid
Количество рук	5
Группа вооружений	Метка: Dose A of ABBV-154 Тип: Experimental Описание: 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 and 66 weeks in the long term extension (LTE) period. Метка: Dose B of ABBV-154 Тип: Experimental Описание: Participants in this group will receive dose B of ABBV-154 SC eow for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period. Метка: Dose C of ABBV-154 EOW Тип: Experimental Описание: Participants in this group will receive dose C of ABBV-154 SC eow for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period. Метка: Dose C of ABBV-154 E4W Тип: Experimental Описание: Participants in this group will receive dose C of ABBV-154 SC every 4 weeks (e4w) for 12 weeks in the placebo-controlled period and 66 weeks in the LTE period. Метка: Placebo Тип: Experimental Описание: 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.
Данные пациента	Yes
Информация о дизайне исследования	Распределение: Randomized Модель вмешательства: Parallel Assignment Первичное назначение: Treatment Маскировка: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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)