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)

September 30, 2024 updated by: AbbVie

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.

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.

Study Overview

Status

Terminated

Conditions

Rheumatoid Arthritis (RA)

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

473

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- New South Wales
  - Botany, New South Wales, Australia, 2019
    - Emeritus Research Sydney /ID# 230070
  - Paramatta, New South Wales, Australia, 2150
    - BJC Health /ID# 229015
- Queensland
  - Maroochydore, Queensland, Australia, 4558
    - Rheumatology Research Unit Sunshine Coast /ID# 229017
- South Australia
  - Woodville South, South Australia, Australia, 5011
    - The Queen Elizabeth Hospital /ID# 230071
- Victoria
  - Camberwell, Victoria, Australia, 3124
    - Emeritus Research /ID# 229018
Canada
- Alberta
  - Edmonton, Alberta, Canada, T5M 0H4
    - Rheumatology Research Associates /ID# 227818
- Manitoba
  - Winnipeg, Manitoba, Canada, R3A 1M3
    - Manitoba Clinic /ID# 227822
- Quebec
  - Sainte-foy, Quebec, Canada, G1V 3M7
    - Groupe de Recherche en Maladies Osseuses Inc /ID# 227821
  - Trois-rivières, Quebec, Canada, G8Z 1Y2
    - Centre de Recherche Musculo-Squelettique /ID# 227824
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7H 5M7
    - Dr Naik-Medical Professional Corporation-Alliance Health /ID# 227823
Czechia
- - Praha, Czechia, 128 00
    - Revmatologicky ustav v Praze /ID# 229188
  - Praha, Czechia, 130 00
    - PV MEDICAL Services s.r.o. /ID# 228265
  - Praha, Czechia, 140 00
    - Revmatologicka ambulance - MUDr. Zuzana Urbanova /ID# 227775
  - Praha, Czechia, 150 06
    - Fakultni Nemocnice v Motole /ID# 231622
  - Uherske Hradiste, Czechia, 686 01
    - MEDICAL PLUS, s.r.o. /ID# 228030
  - Velke Bilovice, Czechia, 691 02
    - RHEUMA s.r.o. /ID# 230850
Germany
- - Berlin, Germany, 10117
    - Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 229526
  - Hamburg, Germany, 20095
    - MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 227785
- Nordrhein-Westfalen
  - Herne, Nordrhein-Westfalen, Germany, 44649
    - Rheumazentrum Ruhrgebiet /ID# 227850
Greece
- - Thessaloniki, Greece, 54642
    - General Hospital of Thessaloniki Hippokrateio /ID# 229614
- Attiki
  - Athens, Attiki, Greece, 11527
    - General Hospital of Athens Gennimatas /ID# 227806
- Kriti
  - Heraklion, Kriti, Greece, 71500
    - University General Hospital of Heraklion PA.G.N.I /ID# 227804
- Thessaloniki
  - Efkarpia (Thessalonikis), Thessaloniki, Greece, 56429
    - 424 General MILITARY Hospital /ID# 227805
Hungary
- - Balatonfüred, Hungary, 8230
    - DRC Gyogyszervizsgalo Kozpont Kft /ID# 228365
  - Budapest, Hungary, 1023
    - Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 227671
  - Budapest, Hungary, 1027
    - Revita Reumatologiai Rendelo /ID# 227668
  - Szekesfehervar, Hungary, 8000
    - CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 227670
  - Veszprém, Hungary, 8200
    - Vital Medical Center Orvosi es Fogaszati Kozpont (Vital Medicina Kft.) /ID# 227669
  - Zalaegerszeg, Hungary, 8900
    - Obudai Egeszsegugyi Centrum Kft. Zalaegerszeg /ID# 228374
- Hajdu-Bihar
  - Debrecen, Hajdu-Bihar, Hungary, 4032
    - Debreceni Egyetem Klinikai Kozpont /ID# 228371
- Pest
  - Budapest, Pest, Hungary, 1036
    - Obudai Egeszsegugyi Centrum Kft. /ID# 228359
Israel
- H_efa
  - Haifa, H_efa, Israel, 3109601
    - Rambam Health Care Campus /ID# 226798
  - Haifa, H_efa, Israel, 3339419
    - Bnai Zion Medical Center /ID# 226801
  - Haifa, H_efa, Israel, 34362
    - The Lady Davis Carmel Medical Center /ID# 226802
- HaMerkaz
  - Kfar Saba, HaMerkaz, Israel, 4428164
    - Meir Medical Center /ID# 226800
- Tel-Aviv
  - Ramat Gan, Tel-Aviv, Israel, 5265601
    - The Chaim Sheba Medical Center /ID# 226797
  - Tel Aviv, Tel-Aviv, Israel, 6423906
    - Tel Aviv Sourasky Medical Center /ID# 228341
Italy
- - Ancona, Italy, 60126
    - Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 228581
  - Palermo, Italy, 90127
    - Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 228583
- Lazio
  - Rome, Lazio, Italy, 00128
    - Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 228917
Japan
- Aichi
  - Nagoya-shi, Aichi, Japan, 455-8530
    - Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 229899
  - Nagoya-shi, Aichi, Japan, 457-8511
    - Daido Clinic /ID# 229280
- Fukui
  - Fukui-shi, Fukui, Japan, 910-0068
    - Sugimoto rheumatology and internal medicine clinic /ID# 229495
- Fukuoka
  - Fukuoka shi, Fukuoka, Japan, 810-8563
    - National Hospital Organization Kyushu Medical Center /ID# 228642
  - Fukuoka-shi, Fukuoka, Japan, 810-8539
    - Hamanomachi Hospital /ID# 228644
  - Fukuoka-shi, Fukuoka, Japan, 814-0002
    - Shono Rheumatism Clinic /ID# 229054
- Hokkaido
  - Asahikawa-shi, Hokkaido, Japan, 078-8243
    - Katayama Orthopedic Rheumatology Clinic /ID# 229277
  - Sapporo-shi, Hokkaido, Japan, 060-0001
    - Sagawa Akira Rheumatology Clin /ID# 228787
- Hyogo
  - Kato-shi, Hyogo, Japan, 673-1462
    - Matsubara Mayflower Hospital /ID# 228948
- Kagawa
  - Sanuki-shi, Kagawa, Japan, 769-2393
    - Sanuki Municipal Hospital /ID# 229276
- Kochi
  - Kochi-shi, Kochi, Japan, 781-0112
    - Bay Side Misato Medical Center /ID# 228947
- Kumamoto
  - Kumamoto shi, Kumamoto, Japan, 8620975
    - Kumamoto Orthopaedic Hospital /ID# 228641
- Miyazaki
  - Miyazaki-shi, Miyazaki, Japan, 880-0053
    - Medical Corporation Keiai Kai Clinic /ID# 228547
- Nagasaki
  - Sasebo-shi, Nagasaki, Japan, 857-1195
    - Sasebo Chuo Hospital /ID# 229168
- Niigata
  - Nagaoka-shi, Niigata, Japan, 940-2085
    - Nagaoka Red Cross Hospital /ID# 229962
- Osaka
  - Kawachinagano Shi, Osaka, Japan, 586-8521
    - National Hospital Organization Osaka Minami Medical Center /ID# 229174
  - Osaka-shi, Osaka, Japan, 534-0021
    - Osaka City General Hospital /ID# 228786
  - Osaka-shi, Osaka, Japan, 543-8555
    - Japanese Red Cross Osaka Hospital /ID# 229816
- Saitama
  - Sayama-shi, Saitama, Japan, 350-1305
    - Azuma Rheumatology Clinic /ID# 230078
- Tokyo
  - Chuo-ku, Tokyo, Japan, 104-8560
    - St.Luke's International Hospital /ID# 229492
  - Meguro-ku, Tokyo, Japan, 152-8902
    - National Hospital Organization Tokyo Medical Center /ID# 228720
  - Sumida-ku, Tokyo, Japan, 130-0013
    - Medical Corporation Uchida Clinic /ID# 229494
- Yamaguchi
  - Shimonoseki-shi, Yamaguchi, Japan, 752-0976
    - Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 228354
Korea, Republic of
- - Daegu, Korea, Republic of, 41944
    - Kyungpook National University Hospital /ID# 227657
  - Incheon, Korea, Republic of, 22332
    - Inha University Hospital /ID# 227656
  - Seoul, Korea, Republic of, 05505
    - Asan Medical Center /ID# 227655
- Chungcheongnamdo
  - Cheonan-si, Chungcheongnamdo, Korea, Republic of, 31151
    - SoonChunHyang University CheonAn Hospital /ID# 228146
- Seoul Teugbyeolsi
  - Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
    - Yonsei University Health System Severance Hospital /ID# 227659
  - Seoul, Seoul Teugbyeolsi, Korea, Republic of, 04763
    - Hanyang University Seoul Hospital /ID# 227658
Netherlands
- - Amsterdam, Netherlands, 1105 AZ
    - Academisch Medisch Centrum /ID# 227234
  - Maastricht, Netherlands, 6229 HX
    - Maastricht Universitair Medisch Centrum /ID# 227235
New Zealand
- Auckland
  - Papatoetoe, Auckland, New Zealand, 2025
    - Aotearoa Clinical Trials /ID# 229012
- Canterbury
  - Timaru, Canterbury, New Zealand, 7910
    - Timaru Medical Specialists Ltd /ID# 229013
- Wellington
  - Newtown, Wellington, New Zealand, 6021
    - Wellington Regional Hospital /ID# 233517
Poland
- - Warsaw, Poland, 00-874
    - MICS Centrum Medyczne Warszawa /ID# 231133
- Kujawsko-pomorskie
  - Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
    - Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 227939
- Lodzkie
  - Lodz, Lodzkie, Poland, 90-644
    - AMICARE Sp. z o.o. sp.k. /ID# 231327
- Mazowieckie
  - Warszawa, Mazowieckie, Poland, 02-691
    - Centrum Medyczne Reuma Park /ID# 227170
- Podkarpackie
  - Stalowa Wola, Podkarpackie, Poland, 37-450
    - SANUS Szpital Specjalistyczny /ID# 227171
- Podlaskie
  - Bialystok, Podlaskie, Poland, 15-879
    - ClinicMed Daniluk, Nowak Sp.k. /ID# 227919
- Pomorskie
  - Gdansk, Pomorskie, Poland, 80-546
    - Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 228047
Puerto Rico
- - San Juan, Puerto Rico, 00917-3104
    - GCM Medical Group PSC /ID# 228981
  - San Juan, Puerto Rico, 00918-3756
    - Mindful Medical Research /ID# 228982
Russian Federation
- - Moscow, Russian Federation, 117593
    - Central Clinical Hospital of Russian Academy of Science /ID# 229438
  - Pushkin, Russian Federation, 196603
    - Euromedservice /ID# 227933
  - St. Petersburg, Russian Federation, 190068
    - Clinical Rheumatologic Hospital No 25 /ID# 227922
- Moskovskaya Oblast
  - Moscow, Moskovskaya Oblast, Russian Federation, 129110
    - Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 228755
- Moskva
  - Korolev, Moskva, Russian Federation, 141060
    - LLC Family Outpatient Clinic No /ID# 227926
- Sverdlovskaya Oblast
  - Yekaterinburg, Sverdlovskaya Oblast, Russian Federation, 620109
    - Family Clinic /ID# 227929
- Tatarstan, Respublika
  - Kazan, Tatarstan, Respublika, Russian Federation, 420012
    - Kazan State Medical University /ID# 227927
Slovakia
- - Martin, Slovakia, 036 01
    - MEDMAN s.r.o. /ID# 227826
  - Nove Mesto nad Vahom, Slovakia, 915 01
    - Reum.hapi s.r.o. /ID# 227825
  - Piestany, Slovakia, 921 01
    - Thermium s.r.o. /ID# 227816
  - Poprad, Slovakia, 058 01
    - REUMAMED POPRAD s.r.o. /ID# 229628
  - Rimavska Sobota, Slovakia, 979 01
    - Reumex, s.r.o. /ID# 227827
Spain
- - A Coruna, Spain, 15006
    - Hospital Universitario A Coruna - CHUAC /ID# 227419
  - Madrid, Spain, 28040
    - Hospital Universitario Fundacion Jimenez Diaz /ID# 234115
  - Madrid, Spain, 28041
    - Hospital Universitario 12 de Octubre /ID# 227743
  - Malaga, Spain, 29011
    - Hospital Regional Universitario de Malaga /ID# 227418
  - Sevilla, Spain, 41014
    - Hospital Universitario Virgen de Valme /ID# 227417
  - Valencia, Spain, 46026
    - Hospital Universitario y Politecnico La Fe /ID# 227408
- A Coruna
  - Santiago de Compostela, A Coruna, Spain, 15706
    - Hospital Clínico Universitario de Santiago-CHUS /ID# 227420
- Barcelona
  - Sabadell, Barcelona, Spain, 08208
    - Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 227666
- Vizcaya
  - Bilbao, Vizcaya, Spain, 48013
    - Hospital Universitario Basurto /ID# 227667
Taiwan
- - Chia-Yi, Taiwan, 62247
    - Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 227220
  - New Taipei City, Taiwan, 22060
    - Far Eastern Memorial Hospital /ID# 227373
  - Taipei, Taiwan, 11217
    - Taipei Veterans General Hosp /ID# 227376
  - Taipei City, Taiwan, 100
    - National Taiwan University Hospital /ID# 230001
Turkey
- - Ankara, Turkey, 06590
    - Ankara Univ Medical Faculty /ID# 227797
  - Kocaeli, Turkey, 41380
    - Kocaeli University Med Faculty /ID# 228244
- Ankara
  - Sihhiye, Ankara, Turkey, 06100
    - Hacettepe Universitesi Tip Fak /ID# 227796
Ukraine
- - Kharkiv, Ukraine, 61029
    - MNI City Multidisciplinary Hospital #18 Kharkiv City Council /ID# 228961
  - Khmelnytskyi, Ukraine, 29000
    - Khmelnytskyi Regional Hospital /ID# 230680
  - Kyiv, Ukraine, 01023
    - Medical Center of Medical Clinic Blagomed LLC /ID# 228956
  - Kyiv, Ukraine, 04050
    - Medical Center CONSILIUM MEDICAL /ID# 228959
  - Kyiv, Ukraine, 02091
    - Medical Center "OK! Clinic+" LLC, "International Institute of Clinical Research" /ID# 228958
  - Poltava, Ukraine, 36011
    - PI "Poltava Regional Clinical Hospital n.a. M.V.Sklifosovsky of PCC" /ID# 228962
  - Vinnytsia, Ukraine, 21018
    - CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 228954
  - Vinnytsia, Ukraine, 21029
    - Сlinic Scientific Research Inst of Invalid Rehab ESMС M I Pyrogov VNMU /ID# 228955
United States
- Arizona
  - Phoenix, Arizona, United States, 85018
    - Elite Clinical Studies, LLC /ID# 228227
- Arkansas
  - Jonesboro, Arkansas, United States, 72401-6251
    - Arthritis and Rheumatism Associates /ID# 228201
- California
  - Fullerton, California, United States, 92835
    - Providence Medical Foundation /ID# 228104
  - Huntington Beach, California, United States, 92648
    - Care Access Research, Huntington Beach /ID# 228163
  - La Mesa, California, United States, 91942
    - Purushotham & Akther Kotha MD, Inc /ID# 228120
  - La Palma, California, United States, 90623-1728
    - Arthritis & Osteo Medical Ctr /ID# 228239
  - Los Angeles, California, United States, 90045-6200
    - Pacific Arthritis Care Center - Los Angeles /ID# 229330
  - Northridge, California, United States, 91324
    - California Medical Research Associates /ID# 230131
  - Poway, California, United States, 92064
    - Arthritis Care And Research Center ACRC /ID# 230099
  - San Leandro, California, United States, 94578
    - East Bay Rheumatology Medical /ID# 228099
  - Thousand Oaks, California, United States, 91360-3951
    - Millennium Clinical Trials /ID# 230618
  - Torrance, California, United States, 90502
    - The Lundquist Institute at Harbor-UCLA Medical Center /ID# 228241
  - Tujunga, California, United States, 91042-2706
    - Medvin Clinical Research /ID# 228181
  - Upland, California, United States, 91786
    - Inland Rheum & Osteo Med Grp /ID# 228204
  - Woodland Hills, California, United States, 91364
    - Comprehensive Rheumatology Center /ID# 230132
- Colorado
  - Denver, Colorado, United States, 80230
    - Denver Arthritis Clinic /ID# 228172
- Connecticut
  - Bridgeport, Connecticut, United States, 06606-1827
    - New England Research Associates, LLC /ID# 230127
  - Stamford, Connecticut, United States, 06905
    - Stamford Therapeutics Consorti /ID# 229214
- Delaware
  - Lewes, Delaware, United States, 19958
    - Delaware Arthritis /ID# 229413
- Florida
  - Boca Raton, Florida, United States, 33486
    - Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 228229
  - Brandon, Florida, United States, 33511
    - Bay Area Arthritis and Osteo /ID# 228075
  - Clearwater, Florida, United States, 33765
    - Clinical Research of West Florida, Inc /ID# 228128
  - Daytona Beach, Florida, United States, 32117
    - International Medical Research /ID# 228069
  - DeBary, Florida, United States, 32713-2260
    - Omega Research Debary, LLC /ID# 228293
  - Hialeah, Florida, United States, 33016-1897
    - Neoclinical Research /ID# 228753
  - Jacksonville, Florida, United States, 32209
    - University of Florida /ID# 228242
  - Miami, Florida, United States, 33014
    - Lakes Research, LLC /ID# 228665
  - Miami, Florida, United States, 33136
    - University of Miami /ID# 228737
  - New Port Richey, Florida, United States, 34652
    - Suncoast Clinical Research /ID# 228237
  - Orlando, Florida, United States, 32819
    - HMD Research LLC /ID# 228185
  - Orlando, Florida, United States, 32808
    - Omega Research Group /ID# 229966
  - Ormond Beach, Florida, United States, 32174
    - Millennium Research /ID# 228183
  - Palm Harbor, Florida, United States, 34684
    - Arthritis Center, Inc. /ID# 228209
  - Saint Petersburg, Florida, United States, 33705
    - BayCare Medical Group /ID# 228289
  - Tamarac, Florida, United States, 33321
    - West Broward Rheumatology Associates /ID# 228603
  - Tampa, Florida, United States, 33606-1246
    - Clinical Research of West Florida - Tampa /ID# 228186
  - Winter Park, Florida, United States, 32789
    - Conquest Research /ID# 230560
  - Zephyrhills, Florida, United States, 33542
    - Florida Medical Clinic /ID# 228236
- Georgia
  - Atlanta, Georgia, United States, 30342
    - Arthritis and Rheumatology /ID# 228743
  - Decatur, Georgia, United States, 30033
    - Jefrey D. Lieberman, MD, P.C. /ID# 230129
  - Gainesville, Georgia, United States, 30501
    - Arthritis Center of North GA /ID# 228769
  - Marietta, Georgia, United States, 20060
    - Atlanta Research Center for Rheumatology /ID# 230430
- Illinois
  - Chicago, Illinois, United States, 60640
    - Great Lakes Clinical Trials /ID# 228699
  - Schaumburg, Illinois, United States, 60195-3106
    - Greater Chicago Specialty Physicians /ID# 228282
  - Skokie, Illinois, United States, 60076
    - Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 228174
  - Springfield, Illinois, United States, 62702-3749
    - Springfield Clinic /ID# 228124
- Indiana
  - Granger, Indiana, United States, 46530
    - Beacon Medical Group Clinical Research /ID# 229153
- Iowa
  - Iowa City, Iowa, United States, 52242
    - University of Iowa Hospitals and Clinics /ID# 229217
- Kentucky
  - Paducah, Kentucky, United States, 42001
    - Four Rivers Clinical Research /ID# 230109
- Louisiana
  - Monroe, Louisiana, United States, 71203
    - The Arthritis & Diabetes Clinic, Inc. /ID# 228221
- Maryland
  - Cumberland, Maryland, United States, 21502
    - Klein and Associates MD /ID# 230145
  - Hagerstown, Maryland, United States, 21742
    - Klein and Associates MD - Hagerstown /ID# 230143
  - Wheaton, Maryland, United States, 20902
    - The Center for Rheumatology and Bone Research /ID# 228617
- Michigan
  - Grand Blanc, Michigan, United States, 48439
    - AA Medical Research Center - Grand Blanc /ID# 228604
  - Lansing, Michigan, United States, 48910
    - Advanced Rheumatology, PC /ID# 228684
  - Lansing, Michigan, United States, 48911
    - June DO, PC /ID# 229838
- Mississippi
  - Hattiesburg, Mississippi, United States, 39402
    - Arthritis Associates /ID# 230188
  - Tupelo, Mississippi, United States, 38801-4949
    - Rheumatology Consultants - Clinical Research /ID# 229208
- Missouri
  - Saint Louis, Missouri, United States, 63119-3845
    - Clayton Medical Associates, P.C. dba Saint Louis Rheumatology /ID# 228283
  - Saint Louis, Missouri, United States, 63131-1703
    - West County Rheumatology /ID# 228102
- Montana
  - Kalispell, Montana, United States, 59901
    - Logan Health Research /ID# 228273
- Nevada
  - Las Vegas, Nevada, United States, 89123
    - Advanced Biomedical Research of America /ID# 228596
  - Las Vegas, Nevada, United States, 89128
    - Innovative Health Research /ID# 229209
- New Jersey
  - Freehold, New Jersey, United States, 07728-8307
    - Arthritis and Osteoporosis Associates /ID# 229418
  - Voorhees, New Jersey, United States, 08043
    - Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 228602
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - Albuquerque Center For Rheumatology /ID# 228709
  - Albuquerque, New Mexico, United States, 87102
    - Albuquerque Clinical Trials, Inc /ID# 228925
  - Las Cruces, New Mexico, United States, 88011
    - Arthritis and Osteo Assoc /ID# 228662
- New York
  - Orchard Park, New York, United States, 14127
    - Buffalo Rheumatology and Medicine - Orchard Park /ID# 228710
  - Potsdam, New York, United States, 13676
    - St. Lawrence Health System /ID# 229508
- North Carolina
  - Charlotte, North Carolina, United States, 28211
    - DJL Clinical Research, PLLC /ID# 230133
  - Leland, North Carolina, United States, 28451
    - Cape Fear Arthritis Care /ID# 228747
  - Salisbury, North Carolina, United States, 28144
    - PMG Research of Salisbury /ID# 230627
- North Dakota
  - Minot, North Dakota, United States, 58701
    - Trinity Health Med Arts Clinic /ID# 228202
- Ohio
  - Cincinnati, Ohio, United States, 45267-0585
    - University of Cincinnati /ID# 229212
  - Middleburg Heights, Ohio, United States, 44130
    - Paramount Medical Research Con /ID# 228254
  - Toledo, Ohio, United States, 43606
    - Arthritis Assoc of NW Ohio /ID# 228936
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73102
    - Arthritis and Rheumatology Center of Oklahoma /ID# 228975
  - Oklahoma City, Oklahoma, United States, 73116-7226
    - Rheumatology Associates of Oklahoma /ID# 228701
- Pennsylvania
  - Cranberry Township, Pennsylvania, United States, 16066
    - Advanced Rheumatology & Arthritis Wellness Center /ID# 228608
  - Duncansville, Pennsylvania, United States, 16635
    - Altoona Ctr Clinical Res /ID# 230058
  - Philadelphia, Pennsylvania, United States, 19152
    - Arthritis Group /ID# 229777
  - Wyomissing, Pennsylvania, United States, 19610
    - PA Regional Center for Arthritis and Osteoporosis Research /ID# 228742
- South Carolina
  - Columbia, South Carolina, United States, 29204
    - Columbia Arthritis Center /ID# 228705
- Tennessee
  - Jackson, Tennessee, United States, 38305
    - West Tennessee Research Institute /ID# 228257
- Texas
  - Allen, Texas, United States, 75013-6147
    - Arthritis and Rheumatology Research Institute, PLLC /ID# 228937
  - Allen, Texas, United States, 75013
    - Allen Arthritis /ID# 228712
  - Carrollton, Texas, United States, 75007
    - Trinity Universal Research Associates - Carrollton /ID# 230104
  - Corpus Christi, Texas, United States, 78404
    - Adriana Pop-Moody MD Clinic PA /ID# 230062
  - Lubbock, Texas, United States, 79424
    - West Texas Clinical Research /ID# 228276
  - Lufkin, Texas, United States, 75904-3132
    - P&I Clinical Research /ID# 230183
  - Mesquite, Texas, United States, 75150
    - SW Rheumatology Res. LLC /ID# 228088
  - Plano, Texas, United States, 75024-5283
    - Trinity Universal Research Associates, Inc /ID# 228238
  - Red Oak, Texas, United States, 75154-3981
    - Epic Medical Research /ID# 228097
  - San Antonio, Texas, United States, 78215
    - Sun Research Institute /ID# 228768
  - The Woodlands, Texas, United States, 77382
    - Advanced Rheumatology of Houston /ID# 228170
  - Tomball, Texas, United States, 77375
    - DM Clinical Research - Tomball /ID# 228112
  - Tomball, Texas, United States, 77377
    - Rheumatology Clinic of Houston /ID# 228178
  - Waco, Texas, United States, 76710
    - Arthritis & Osteoporosis Clinic /ID# 228736
- Virginia
  - Newport News, Virginia, United States, 23606-4434
    - Tidewater Physicians Medical Center /ID# 230130
- Washington
  - Spokane, Washington, United States, 99204-2302
    - Arthritis Northwest, PLLC /ID# 228275

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: ABBV-154 Subcutaneous Injection
Experimental: 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.	Drug: ABBV-154 Subcutaneous Injection
Experimental: 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.	Drug: ABBV-154 Subcutaneous Injection
Experimental: 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.	Drug: ABBV-154 Subcutaneous Injection
Experimental: 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.	Drug: ABBV-154 Subcutaneous Injection Drug: Placebo Subcutaneous Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achievement of 50% Improvement as Measured by American College of Rheumatology Response Criteria (ACR50) at Week 12 Time Frame: Week 12	Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR50 response criteria: ≥ 50% improvement in 68-tender joint count; ≥ 50% improvement in 66-swollen joint count; and ≥ 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).	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Disease Activity Score (DAS) 28 (CRP) at Week 12 Time Frame: Baseline to 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.	Baseline to Week 12
Change in Clinical Disease Activity Index (CDAI) at Week 12 Time Frame: Baseline to 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.	Baseline to Week 12
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12 Time Frame: Week 12	Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR20 response criteria: ≥ 20% improvement in 68-tender joint count; ≥ 20% improvement in 66-swollen joint count; and ≥ 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).	Week 12
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12 Time Frame: Week 12	Participants who met the following 3 conditions for improvement from baseline were classified as meeting the ACR70 response criteria: ≥ 70% improvement in 68-tender joint count; ≥ 70% improvement in 66-swollen joint count; and ≥ 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).	Week 12
Percentage of Participants Achieving Low Disease Activity (LDA) Defined by DAS28 (CRP) <= 3.2 at Week 12 Time Frame: 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.	Week 12
Percentage of Participants Achieving LDA Defined by CDAI <= 10 at Week 12 Time Frame: 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.	Week 12
Percentage of Participants Achieving Clinical Remission (CR) Defined by DAS28 (CRP) < 2.6 at Week 12 Time Frame: 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.	Week 12
Percentage of Participants Achieving CR Defined by CDAI <= 2.8 at Week 12 Time Frame: 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.	Week 12
Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) to Week 12 Time Frame: Baseline 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.	Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

Study Director: ABBVIE INC., AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2021

Primary Completion (Actual)

August 25, 2022

Study Completion (Actual)

August 4, 2023

Study Registration Dates

First Submitted

May 13, 2021

First Submitted That Met QC Criteria

May 13, 2021

First Posted (Actual)

May 17, 2021

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

M20-466
2020-005303-39 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

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