AzTrials
AzTrials

Rheumatoid Arthritis (RA)Phase 2NCT04888585

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)

A Phase 2 study testing ABBV-154 in people with Rheumatoid Arthritis (RA), run by AbbVie at 220 sites in 21 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rheumatoid Arthritis (RA)
What is being tested?
ABBV-154
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
473 participants
Where
220 sitesin 21 countries
Study dates
23 Jun 2021to 4 Aug 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

220 sites in 21 countries.

220 sites in 21 countries

United States101 sites

  • Albuquerque Center For Rheumatology /ID# 228709

    Albuquerque, New Mexico, 87102

  • Albuquerque Clinical Trials, Inc /ID# 228925

    Albuquerque, New Mexico, 87102

  • Arthritis and Rheumatology Research Institute, PLLC /ID# 228937

    Allen, Texas, 75013-6147

  • Allen Arthritis /ID# 228712

    Allen, Texas, 75013

  • Arthritis and Rheumatology /ID# 228743

    Atlanta, Georgia, 30342

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

    Boca Raton, Florida, 33486

  • Bay Area Arthritis and Osteo /ID# 228075

    Brandon, Florida, 33511

  • New England Research Associates, LLC /ID# 230127

    Bridgeport, Connecticut, 06606-1827

  • Trinity Universal Research Associates - Carrollton /ID# 230104

    Carrollton, Texas, 75007

  • DJL Clinical Research, PLLC /ID# 230133

    Charlotte, North Carolina, 28211

  • Great Lakes Clinical Trials /ID# 228699

    Chicago, Illinois, 60640

  • University of Cincinnati /ID# 229212

    Cincinnati, Ohio, 45267-0585

  • Clinical Research of West Florida, Inc /ID# 228128

    Clearwater, Florida, 33765

  • Columbia Arthritis Center /ID# 228705

    Columbia, South Carolina, 29204

  • Adriana Pop-Moody MD Clinic PA /ID# 230062

    Corpus Christi, Texas, 78404

  • Advanced Rheumatology & Arthritis Wellness Center /ID# 228608

    Cranberry Township, Pennsylvania, 16066

  • Klein and Associates MD /ID# 230145

    Cumberland, Maryland, 21502

  • International Medical Research /ID# 228069

    Daytona Beach, Florida, 32117

  • Omega Research Debary, LLC /ID# 228293

    DeBary, Florida, 32713-2260

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

    Decatur, Georgia, 30033

  • Denver Arthritis Clinic /ID# 228172

    Denver, Colorado, 80230

  • Altoona Ctr Clinical Res /ID# 230058

    Duncansville, Pennsylvania, 16635

  • Arthritis and Osteoporosis Associates /ID# 229418

    Freehold, New Jersey, 07728-8307

  • Providence Medical Foundation /ID# 228104

    Fullerton, California, 92835

  • Arthritis Center of North GA /ID# 228769

    Gainesville, Georgia, 30501

  • AA Medical Research Center - Grand Blanc /ID# 228604

    Grand Blanc, Michigan, 48439

  • Beacon Medical Group Clinical Research /ID# 229153

    Granger, Indiana, 46530

  • Klein and Associates MD - Hagerstown /ID# 230143

    Hagerstown, Maryland, 21742

  • Arthritis Associates /ID# 230188

    Hattiesburg, Mississippi, 39402

  • Neoclinical Research /ID# 228753

    Hialeah, Florida, 33016-1897

  • Care Access Research, Huntington Beach /ID# 228163

    Huntington Beach, California, 92648

  • University of Iowa Hospitals and Clinics /ID# 229217

    Iowa City, Iowa, 52242

  • West Tennessee Research Institute /ID# 228257

    Jackson, Tennessee, 38305

  • University of Florida /ID# 228242

    Jacksonville, Florida, 32209

  • Arthritis and Rheumatism Associates /ID# 228201

    Jonesboro, Arkansas, 72401-6251

  • Logan Health Research /ID# 228273

    Kalispell, Montana, 59901

  • Purushotham & Akther Kotha MD, Inc /ID# 228120

    La Mesa, California, 91942

  • Arthritis & Osteo Medical Ctr /ID# 228239

    La Palma, California, 90623-1728

  • Advanced Rheumatology, PC /ID# 228684

    Lansing, Michigan, 48910

  • June DO, PC /ID# 229838

    Lansing, Michigan, 48911

  • Arthritis and Osteo Assoc /ID# 228662

    Las Cruces, New Mexico, 88011

  • Advanced Biomedical Research of America /ID# 228596

    Las Vegas, Nevada, 89123

  • Innovative Health Research /ID# 229209

    Las Vegas, Nevada, 89128

  • Cape Fear Arthritis Care /ID# 228747

    Leland, North Carolina, 28451

  • Delaware Arthritis /ID# 229413

    Lewes, Delaware, 19958

  • Pacific Arthritis Care Center - Los Angeles /ID# 229330

    Los Angeles, California, 90045-6200

  • West Texas Clinical Research /ID# 228276

    Lubbock, Texas, 79424

  • P&I Clinical Research /ID# 230183

    Lufkin, Texas, 75904-3132

  • Atlanta Research Center for Rheumatology /ID# 230430

    Marietta, Georgia, 20060

  • SW Rheumatology Res. LLC /ID# 228088

    Mesquite, Texas, 75150

  • Lakes Research, LLC /ID# 228665

    Miami, Florida, 33014

  • University of Miami /ID# 228737

    Miami, Florida, 33136

  • Paramount Medical Research Con /ID# 228254

    Middleburg Heights, Ohio, 44130

  • Trinity Health Med Arts Clinic /ID# 228202

    Minot, North Dakota, 58701

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

    Monroe, Louisiana, 71203

  • Suncoast Clinical Research /ID# 228237

    New Port Richey, Florida, 34652

  • Tidewater Physicians Medical Center /ID# 230130

    Newport News, Virginia, 23606-4434

  • California Medical Research Associates /ID# 230131

    Northridge, California, 91324

  • Arthritis and Rheumatology Center of Oklahoma /ID# 228975

    Oklahoma City, Oklahoma, 73102

  • Rheumatology Associates of Oklahoma /ID# 228701

    Oklahoma City, Oklahoma, 73116-7226

  • Buffalo Rheumatology and Medicine - Orchard Park /ID# 228710

    Orchard Park, New York, 14127

  • Omega Research Group /ID# 229966

    Orlando, Florida, 32808

  • HMD Research LLC /ID# 228185

    Orlando, Florida, 32819

  • Millennium Research /ID# 228183

    Ormond Beach, Florida, 32174

  • Four Rivers Clinical Research /ID# 230109

    Paducah, Kentucky, 42001

  • Arthritis Center, Inc. /ID# 228209

    Palm Harbor, Florida, 34684

  • Arthritis Group /ID# 229777

    Philadelphia, Pennsylvania, 19152

  • Elite Clinical Studies, LLC /ID# 228227

    Phoenix, Arizona, 85018

  • Trinity Universal Research Associates, Inc /ID# 228238

    Plano, Texas, 75024-5283

  • St. Lawrence Health System /ID# 229508

    Potsdam, New York, 13676

  • Arthritis Care And Research Center ACRC /ID# 230099

    Poway, California, 92064

  • Epic Medical Research /ID# 228097

    Red Oak, Texas, 75154-3981

  • PMG Research of Salisbury /ID# 230627

    Salisbury, North Carolina, 28144

  • Sun Research Institute /ID# 228768

    San Antonio, Texas, 78215

  • East Bay Rheumatology Medical /ID# 228099

    San Leandro, California, 94578

  • Greater Chicago Specialty Physicians /ID# 228282

    Schaumburg, Illinois, 60195-3106

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

    Skokie, Illinois, 60076

  • Arthritis Northwest, PLLC /ID# 228275

    Spokane, Washington, 99204-2302

  • Springfield Clinic /ID# 228124

    Springfield, Illinois, 62702-3749

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

    St Louis, Missouri, 63119-3845

  • West County Rheumatology /ID# 228102

    St Louis, Missouri, 63131-1703

  • BayCare Medical Group /ID# 228289

    St. Petersburg, Florida, 33705

  • Stamford Therapeutics Consorti /ID# 229214

    Stamford, Connecticut, 06905

  • West Broward Rheumatology Associates /ID# 228603

    Tamarac, Florida, 33321

  • Clinical Research of West Florida - Tampa /ID# 228186

    Tampa, Florida, 33606-1246

  • Advanced Rheumatology of Houston /ID# 228170

    The Woodlands, Texas, 77382

  • Millennium Clinical Trials /ID# 230618

    Thousand Oaks, California, 91360-3951

  • Arthritis Assoc of NW Ohio /ID# 228936

    Toledo, Ohio, 43606

  • DM Clinical Research - Tomball /ID# 228112

    Tomball, Texas, 77375

  • Rheumatology Clinic of Houston /ID# 228178

    Tomball, Texas, 77377

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

    Torrance, California, 90502

  • Medvin Clinical Research /ID# 228181

    Tujunga, California, 91042-2706

  • Rheumatology Consultants - Clinical Research /ID# 229208

    Tupelo, Mississippi, 38801-4949

  • Inland Rheum & Osteo Med Grp /ID# 228204

    Upland, California, 91786

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

    Voorhees Township, New Jersey, 08043

  • Arthritis & Osteoporosis Clinic /ID# 228736

    Waco, Texas, 76710

  • The Center for Rheumatology and Bone Research /ID# 228617

    Wheaton, Maryland, 20902

  • Conquest Research /ID# 230560

    Winter Park, Florida, 32789

  • Comprehensive Rheumatology Center /ID# 230132

    Woodland Hills, California, 91364

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

    Wyomissing, Pennsylvania, 19610

  • Florida Medical Clinic /ID# 228236

    Zephyrhills, Florida, 33542

Other trials in United States

Japan23 sites

  • Katayama Orthopedic Rheumatology Clinic /ID# 229277

    Asahikawa-shi, Hokkaido, 078-8243

  • St.Luke's International Hospital /ID# 229492

    Chuo-ku, Tokyo, 104-8560

  • Sugimoto rheumatology and internal medicine clinic /ID# 229495

    Fukui-shi, Fukui, 910-0068

  • Hamanomachi Hospital /ID# 228644

    Fukuoka, Fukuoka, 810-8539

  • National Hospital Organization Kyushu Medical Center /ID# 228642

    Fukuoka, Fukuoka, 810-8563

  • Shono Rheumatism Clinic /ID# 229054

    Fukuoka, Fukuoka, 814-0002

  • Matsubara Mayflower Hospital /ID# 228948

    Kato-shi, Hyōgo, 673-1462

  • National Hospital Organization Osaka Minami Medical Center /ID# 229174

    Kawachinagano Shi, Osaka, 586-8521

  • Bay Side Misato Medical Center /ID# 228947

    Kochi, Kochi, 781-0112

  • Kumamoto Orthopaedic Hospital /ID# 228641

    Kumamoto, Kumamoto, 8620975

  • National Hospital Organization Tokyo Medical Center /ID# 228720

    Meguro-ku, Tokyo, 152-8902

  • Medical Corporation Keiai Kai Clinic /ID# 228547

    Miyazaki, Miyazaki, 880-0053

  • Nagaoka Red Cross Hospital /ID# 229962

    Nagaoka-shi, Niigata, 940-2085

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

    Nagoya, Aichi-ken, 455-8530

  • Daido Clinic /ID# 229280

    Nagoya, Aichi-ken, 457-8511

  • Osaka City General Hospital /ID# 228786

    Osaka, Osaka, 534-0021

  • Japanese Red Cross Osaka Hospital /ID# 229816

    Osaka, Osaka, 543-8555

  • Sanuki Municipal Hospital /ID# 229276

    Sanuki-shi, Kagawa-ken, 769-2393

  • Sagawa Akira Rheumatology Clin /ID# 228787

    Sapporo, Hokkaido, 060-0001

  • Sasebo Chuo Hospital /ID# 229168

    Sasebo-shi, Nagasaki, 857-1195

  • Azuma Rheumatology Clinic /ID# 230078

    Sayama-shi, Saitama, 350-1305

  • Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 228354

    Shimonoseki-shi, Yamaguchi, 752-0976

  • Medical Corporation Uchida Clinic /ID# 229494

    Sumida-ku, Tokyo, 130-0013

Other trials in Japan

Spain9 sites

  • Hospital Universitario A Coruna - CHUAC /ID# 227419

    A Coruña, 15006

  • Hospital Universitario Basurto /ID# 227667

    Bilbao, Vizcaya, 48013

  • Hospital Universitario Fundacion Jimenez Diaz /ID# 234115

    Madrid, 28040

  • Hospital Universitario 12 de Octubre /ID# 227743

    Madrid, 28041

  • Hospital Regional Universitario de Malaga /ID# 227418

    Málaga, 29011

  • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 227666

    Sabadell, Barcelona, 08208

  • Hospital Clínico Universitario de Santiago-CHUS /ID# 227420

    Santiago de Compostela, A Coruna, 15706

  • Hospital Universitario Virgen de Valme /ID# 227417

    Seville, 41014

  • Hospital Universitario y Politecnico La Fe /ID# 227408

    Valencia, 46026

Other trials in Spain

Hungary8 sites

  • DRC Gyogyszervizsgalo Kozpont Kft /ID# 228365

    Balatonfüred, 8230

  • Obudai Egeszsegugyi Centrum Kft. /ID# 228359

    Budapest, Pest County, 1036

  • Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 227671

    Budapest, 1023

  • Revita Reumatologiai Rendelo /ID# 227668

    Budapest, 1027

  • Debreceni Egyetem Klinikai Kozpont /ID# 228371

    Debrecen, Hajdú-Bihar, 4032

  • CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 227670

    Székesfehérvár, 8000

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

    Veszprém, 8200

  • Obudai Egeszsegugyi Centrum Kft. Zalaegerszeg /ID# 228374

    Zalaegerszeg, 8900

Other trials in Hungary

Ukraine8 sites

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

    Kharkiv, 61029

  • Khmelnytskyi Regional Hospital /ID# 230680

    Khmelnytskyi, 29000

  • Medical Center of Medical Clinic Blagomed LLC /ID# 228956

    Kyiv, 01023

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

    Kyiv, 02091

  • Medical Center CONSILIUM MEDICAL /ID# 228959

    Kyiv, 04050

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

    Poltava, 36011

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

    Vinnytsia, 21018

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

    Vinnytsia, 21029

Other trials in Ukraine

Poland7 sites

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

    Bialystok, Podlaskie Voivodeship, 15-879

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

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

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

    Gdansk, Pomeranian Voivodeship, 80-546

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

    Lodz, Łódź Voivodeship, 90-644

  • SANUS Szpital Specjalistyczny /ID# 227171

    Stalowa Wola, Podkarpackie Voivodeship, 37-450

  • Centrum Medyczne Reuma Park /ID# 227170

    Warsaw, Masovian Voivodeship, 02-691

  • MICS Centrum Medyczne Warszawa /ID# 231133

    Warsaw, 00-874

Other trials in Poland

Russia7 sites

  • Kazan State Medical University /ID# 227927

    Kazan', Tatarstan, Respublika, 420012

  • LLC Family Outpatient Clinic No /ID# 227926

    Korolev, Moscow, 141060

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

    Moscow, Moscow Oblast, 129110

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

    Moscow, 117593

  • Euromedservice /ID# 227933

    Pushkin, 196603

  • Clinical Rheumatologic Hospital No 25 /ID# 227922

    Saint Petersburg, 190068

  • Family Clinic /ID# 227929

    Yekaterinburg, Sverdlovsk Oblast, 620109

Other trials in Russia

Czechia6 sites

  • Revmatologicky ustav v Praze /ID# 229188

    Prague, 128 00

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

    Prague, 130 00

  • Revmatologicka ambulance - MUDr. Zuzana Urbanova /ID# 227775

    Prague, 140 00

  • Fakultni Nemocnice v Motole /ID# 231622

    Prague, 150 06

  • MEDICAL PLUS, s.r.o. /ID# 228030

    Uherské Hradiště, 686 01

  • RHEUMA s.r.o. /ID# 230850

    Velké Bílovice, 691 02

Other trials in Czechia

Israel6 sites

  • Rambam Health Care Campus /ID# 226798

    Haifa, H_efa, 3109601

  • Bnai Zion Medical Center /ID# 226801

    Haifa, H_efa, 3339419

  • The Lady Davis Carmel Medical Center /ID# 226802

    Haifa, H_efa, 34362

  • Meir Medical Center /ID# 226800

    Kfar Saba, Central District, 4428164

  • The Chaim Sheba Medical Center /ID# 226797

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 228341

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

South Korea6 sites

  • SoonChunHyang University CheonAn Hospital /ID# 228146

    Cheonan-si, Chungcheongnam-do, 31151

  • Kyungpook National University Hospital /ID# 227657

    Daegu, 41944

  • Inha University Hospital /ID# 227656

    Incheon, 22332

  • Yonsei University Health System Severance Hospital /ID# 227659

    Seoul, Seoul Teugbyeolsi, 03722

  • Hanyang University Seoul Hospital /ID# 227658

    Seoul, Seoul Teugbyeolsi, 04763

  • Asan Medical Center /ID# 227655

    Seoul, 05505

Other trials in South Korea

Australia5 sites

  • Emeritus Research Sydney /ID# 230070

    Botany, New South Wales, 2019

  • Emeritus Research /ID# 229018

    Camberwell, Victoria, 3124

  • Rheumatology Research Unit Sunshine Coast /ID# 229017

    Maroochydore, Queensland, 4558

  • BJC Health /ID# 229015

    Parramatta, New South Wales, 2150

  • The Queen Elizabeth Hospital /ID# 230071

    Woodville South, South Australia, 5011

Other trials in Australia

Canada5 sites

  • Rheumatology Research Associates /ID# 227818

    Edmonton, Alberta, T5M 0H4

  • Groupe de Recherche en Maladies Osseuses Inc /ID# 227821

    Sainte-Foy, Quebec, G1V 3M7

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

    Saskatoon, Saskatchewan, S7H 5M7

  • Centre de Recherche Musculo-Squelettique /ID# 227824

    Trois-Rivières, Quebec, G8Z 1Y2

  • Manitoba Clinic /ID# 227822

    Winnipeg, Manitoba, R3A 1M3

Other trials in Canada

Slovakia5 sites

  • MEDMAN s.r.o. /ID# 227826

    Martin, 036 01

  • Reum.hapi s.r.o. /ID# 227825

    Nové Mesto nad Váhom, 915 01

  • Thermium s.r.o. /ID# 227816

    Piešťany, 921 01

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

    Poprad, 058 01

  • Reumex, s.r.o. /ID# 227827

    Rimavská Sobota, 979 01

Other trials in Slovakia

Greece4 sites

  • General Hospital of Athens Gennimatas /ID# 227806

    Athens, Attica, 11527

  • 424 General MILITARY Hospital /ID# 227805

    Efkarpia (Thessalonikis), Thessaloniki, 56429

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

    Heraklion, Crete, 71500

  • General Hospital of Thessaloniki Hippokrateio /ID# 229614

    Thessaloniki, 54642

Other trials in Greece

Taiwan4 sites

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

    Chiayi City, 62247

  • Far Eastern Memorial Hospital /ID# 227373

    New Taipei City, 22060

  • National Taiwan University Hospital /ID# 230001

    Taipei, 100

  • Taipei Veterans General Hosp /ID# 227376

    Taipei, 11217

Other trials in Taiwan

Germany3 sites

  • Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 229526

    Berlin, 10117

  • MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 227785

    Hamburg, 20095

  • Rheumazentrum Ruhrgebiet /ID# 227850

    Herne, North Rhine-Westphalia, 44649

Other trials in Germany

Italy3 sites

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 228581

    Ancona, 60126

  • Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 228583

    Palermo, 90127

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

    Rome, Lazio, 00128

Other trials in Italy

New Zealand3 sites

  • Wellington Regional Hospital /ID# 233517

    Newtown, Wellington Region, 6021

  • Aotearoa Clinical Trials /ID# 229012

    Papatoetoe, Auckland, 2025

  • Timaru Medical Specialists Ltd /ID# 229013

    Timaru, Canterbury, 7910

Other trials in New Zealand

Turkey (Türkiye)3 sites

  • Ankara Univ Medical Faculty /ID# 227797

    Ankara, 06590

  • Kocaeli University Med Faculty /ID# 228244

    Kocaeli, 41380

  • Hacettepe Universitesi Tip Fak /ID# 227796

    Sihhiye, Ankara, 06100

Other trials in Turkey (Türkiye)

Netherlands2 sites

  • Academisch Medisch Centrum /ID# 227234

    Amsterdam, 1105 AZ

  • Maastricht Universitair Medisch Centrum /ID# 227235

    Maastricht, 6229 HX

Other trials in Netherlands

Puerto Rico2 sites

  • GCM Medical Group PSC /ID# 228981

    San Juan, 00917-3104

  • Mindful Medical Research /ID# 228982

    San Juan, 00918-3756

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to Biologic and/or Targeted Synthetic Disease-Modifying Anti-Rheumatic Drugs (b/tsDMARDs)

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.

Read more

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.

Read the 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.

Being tested
ABBV-154, Placebo
Keywords
Rheumatoid Arthritis (RA), ABBV-154, AIM-RA
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABBV-154Drug

    Subcutaneous Injection

  • PlaceboDrug

    Subcutaneous Injection

Study groups in NCT04888585
Study groupRoleWhat they receive
Dose A of ABBV-154ExperimentalParticipants 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.
Receives: Drug: ABBV-154
Dose B of ABBV-154ExperimentalParticipants 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.
Receives: Drug: ABBV-154
Dose C of ABBV-154 EOWExperimentalParticipants 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.
Receives: Drug: ABBV-154
Dose C of ABBV-154 E4WExperimentalParticipants 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.
Receives: Drug: ABBV-154
PlaceboExperimentalParticipants 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.
Receives: Drug: ABBV-154; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Achievement of 50% Improvement as Measured by American College of Rheumatology Response Criteria (ACR50) at Week 12

    Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria:

    1. ≥ 50% improvement in 68-tender joint count;
    2. ≥ 50% improvement in 66-swollen joint count; and
    3. ≥ 50% improvement in at least 3 of the 5 following parameters:
    • Physician's Global Assessment of Disease Activity (NRS)
    • Patient's Global Assessment of Disease Activity (NRS)
    • Patient's Assessment of Pain (NRS)
    • Health Assessment Questionnaire - Disability Index (HAQ-DI)
    • High-sensitivity C-reactive protein (hsCRP).

    Measured: Week 12

Secondary outcomes (9)

  1. Change From Baseline in Disease Activity Score (DAS) 28 (CRP) at Week 12

    The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity. A negative change from Baseline in DAS28 (CRP) indicates improvement in disease activity.

    Measured: Baseline to Week 12

  2. Change in Clinical Disease Activity Index (CDAI) at Week 12

    CDAI is a composite index for assessing disease activity based on the sum of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and Physician's Global Assessment of Disease Activity (NRS). The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity.

    Measured: Baseline to Week 12

  3. Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12

    Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria:

    1. ≥ 20% improvement in 68-tender joint count;
    2. ≥ 20% improvement in 66-swollen joint count; and
    3. ≥ 20% improvement in at least 3 of the 5 following parameters:
    • Physician's Global Assessment of Disease Activity (NRS)
    • Patient's Global Assessment of Disease Activity (NRS)
    • Patient's Assessment of Pain (NRS)
    • Health Assessment Questionnaire - Disability Index (HAQ-DI)
    • High-sensitivity C-reactive protein (hsCRP).

    Measured: Week 12

  4. Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12

    Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria:

    1. ≥ 70% improvement in 68-tender joint count;
    2. ≥ 70% improvement in 66-swollen joint count; and
    3. ≥ 70% improvement in at least 3 of the 5 following parameters:
    • Physician's Global Assessment of Disease Activity (NRS)
    • Patient's Global Assessment of Disease Activity (NRS)
    • Patient's Assessment of Pain (NRS)
    • Health Assessment Questionnaire - Disability Index (HAQ-DI)
    • High-sensitivity C-reactive protein (hsCRP).

    Measured: Week 12

  5. Percentage of Participants Achieving Low Disease Activity (LDA) Defined by DAS28 (CRP) <= 3.2 at Week 12

    Low disease activity (LDA) was defined as a DAS28 score less than or equal to 3.2. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS) and Physician's Global Assessment of Disease Activity (NRS), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.

    Measured: Week 12

  6. Percentage of Participants Achieving LDA Defined by CDAI <= 10 at Week 12

    Low disease activity based on CDAI is defined as a CDAI score less than or equal to 10. CDAI is a composite index for assessing disease activity based on the sum of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and Physician's Global Assessment of Disease Activity (NRS). The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity.

    Measured: Week 12

  7. Percentage of Participants Achieving Clinical Remission (CR) Defined by DAS28 (CRP) < 2.6 at Week 12

    Clinical remission was defined as a DAS28 (CRP) score less than 2.6. The DAS28 is a composite index used to assess rheumatoid arthritis disease activity, calculated based on the tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and hsCRP (in mg/L). Scores on the DAS28 range from 0 to approximately 10, where higher scores indicate more disease activity.

    Measured: Week 12

  8. Percentage of Participants Achieving CR Defined by CDAI <= 2.8 at Week 12

    Clinical Remission was defined by CDAI as a score less than or equal to 2.8. CDAI is a composite index for assessing disease activity based on the summation of the total tender joint count (out of 28 evaluated joints), swollen joint count (out of 28 evaluated joints), Patient's Global Assessment of Disease Activity (NRS), and Physician's Global Assessment of Disease Activity (NRS). The total CDAI score ranges from 0 to 76 with higher scores indicating higher disease activity.

    Measured: Week 12

  9. Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) to Week 12

    The Health Assessment Questionnaire - Disability Index is a participant-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability. A negative change from Baseline in the overall score indicates improvement.

    Measured: Baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2021
  2. Study start23 Jun 2021
  3. Primary completion25 Aug 2022
  4. Study completion4 Aug 2023

Why it stopped: Business decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
473 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04888585
Sponsor's protocol ID
M20-466
Other IDs
2020-005303-39
Status last verified
Sep 2024
First submitted
13 May 2021
Last updated
8 Oct 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABBV-154 in people with Rheumatoid Arthritis (RA), run by AbbVie at 220 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 220 sites in United States, Japan, Spain, Hungary, Ukraine and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Achievement of 50% Improvement as Measured by American College of Rheumatology Response Criteria (ACR50) at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04888585.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.

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