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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 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)
2 other identifiers
interventional
473
21 countries
220
Brief Summary
Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. This study evaluated how safe and effective ABBV-154 is in participants treated for moderately to severely active RA. Adverse events and change in the disease activity were assessed. ABBV-154 is an investigational drug being evaluated for the treatment of RA. Study doctors placed the participants in 1 of 5 treatment groups or arms; each arm received a different treatment. There was a 1 in 5 chance that participants were assigned to placebo. Participants 18-75 years of age with moderate to severe RA were enrolled. Around 425 participants were to be enrolled in the study at approximately 270 sites worldwide. The study was comprised of a 12 week placebo-controlled period, a double-blind long term extension (LTE) period 1 of 66 weeks, a LTE period 2 of 104 weeks and a follow-up visit 70 days after the last dose of the study drug. In the LTE period 1, participants in the placebo group were re-randomized to receive ABBV-154 at 1 of 2 different doses SC every other week (EOW). Other participants remained on their previous dose and dosing regimen of ABBV-154. There may have been a higher treatment burden for participants in this trial compared to their standard of care. Participants attended regular visits during the study at a hospital or clinic. The effect of the treatment was checked by medical assessments, blood tests, and side effects, and completing questionnaires.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2021
220 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2021
CompletedFirst Posted
Study publicly available on registry
May 17, 2021
CompletedStudy Start
First participant enrolled
June 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 25, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 4, 2023
CompletedResults Posted
Study results publicly available
October 8, 2024
CompletedOctober 8, 2024
September 1, 2024
1.2 years
May 13, 2021
August 19, 2024
September 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (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).
Week 12
Secondary Outcomes (9)
Change From Baseline in Disease Activity Score (DAS) 28 (CRP) at Week 12
Baseline to Week 12
Change in Clinical Disease Activity Index (CDAI) at Week 12
Baseline to Week 12
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Week 12
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 12
Week 12
Percentage of Participants Achieving Low Disease Activity (LDA) Defined by DAS28 (CRP) <= 3.2 at Week 12
Week 12
- +4 more secondary outcomes
Study Arms (5)
Dose A of ABBV-154
EXPERIMENTALParticipants 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.
Dose B of ABBV-154
EXPERIMENTALParticipants 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.
Dose C of ABBV-154 EOW
EXPERIMENTALParticipants 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.
Dose C of ABBV-154 E4W
EXPERIMENTALParticipants 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.
Placebo
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- \- Participant discontinued prior adalimumab therapy due to intolerability or toxicity.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (220)
Elite Clinical Studies, LLC /ID# 228227
Phoenix, Arizona, 85018, United States
Arthritis and Rheumatism Associates /ID# 228201
Jonesboro, Arkansas, 72401-6251, United States
Providence Medical Foundation /ID# 228104
Fullerton, California, 92835, United States
Care Access Research, Huntington Beach /ID# 228163
Huntington Beach, California, 92648, United States
Purushotham & Akther Kotha MD, Inc /ID# 228120
La Mesa, California, 91942, United States
Arthritis & Osteo Medical Ctr /ID# 228239
La Palma, California, 90623-1728, United States
Pacific Arthritis Care Center - Los Angeles /ID# 229330
Los Angeles, California, 90045-6200, United States
California Medical Research Associates /ID# 230131
Northridge, California, 91324, United States
Arthritis Care And Research Center ACRC /ID# 230099
Poway, California, 92064, United States
East Bay Rheumatology Medical /ID# 228099
San Leandro, California, 94578, United States
Millennium Clinical Trials /ID# 230618
Thousand Oaks, California, 91360-3951, United States
The Lundquist Institute at Harbor-UCLA Medical Center /ID# 228241
Torrance, California, 90502, United States
Medvin Clinical Research /ID# 228181
Tujunga, California, 91042-2706, United States
Inland Rheum & Osteo Med Grp /ID# 228204
Upland, California, 91786, United States
Comprehensive Rheumatology Center /ID# 230132
Woodland Hills, California, 91364, United States
Denver Arthritis Clinic /ID# 228172
Denver, Colorado, 80230, United States
New England Research Associates, LLC /ID# 230127
Bridgeport, Connecticut, 06606-1827, United States
Stamford Therapeutics Consorti /ID# 229214
Stamford, Connecticut, 06905, United States
Delaware Arthritis /ID# 229413
Lewes, Delaware, 19958, United States
Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 228229
Boca Raton, Florida, 33486, United States
Bay Area Arthritis and Osteo /ID# 228075
Brandon, Florida, 33511, United States
Clinical Research of West Florida, Inc /ID# 228128
Clearwater, Florida, 33765, United States
International Medical Research /ID# 228069
Daytona Beach, Florida, 32117, United States
Omega Research Debary, LLC /ID# 228293
DeBary, Florida, 32713-2260, United States
Neoclinical Research /ID# 228753
Hialeah, Florida, 33016-1897, United States
University of Florida /ID# 228242
Jacksonville, Florida, 32209, United States
Lakes Research, LLC /ID# 228665
Miami, Florida, 33014, United States
University of Miami /ID# 228737
Miami, Florida, 33136, United States
Suncoast Clinical Research /ID# 228237
New Port Richey, Florida, 34652, United States
Omega Research Group /ID# 229966
Orlando, Florida, 32808, United States
HMD Research LLC /ID# 228185
Orlando, Florida, 32819, United States
Millennium Research /ID# 228183
Ormond Beach, Florida, 32174, United States
Arthritis Center, Inc. /ID# 228209
Palm Harbor, Florida, 34684, United States
BayCare Medical Group /ID# 228289
St. Petersburg, Florida, 33705, United States
West Broward Rheumatology Associates /ID# 228603
Tamarac, Florida, 33321, United States
Clinical Research of West Florida - Tampa /ID# 228186
Tampa, Florida, 33606-1246, United States
Conquest Research /ID# 230560
Winter Park, Florida, 32789, United States
Florida Medical Clinic /ID# 228236
Zephyrhills, Florida, 33542, United States
Arthritis and Rheumatology /ID# 228743
Atlanta, Georgia, 30342, United States
Jefrey D. Lieberman, MD, P.C. /ID# 230129
Decatur, Georgia, 30033, United States
Arthritis Center of North GA /ID# 228769
Gainesville, Georgia, 30501, United States
Atlanta Research Center for Rheumatology /ID# 230430
Marietta, Georgia, 20060, United States
Great Lakes Clinical Trials /ID# 228699
Chicago, Illinois, 60640, United States
Greater Chicago Specialty Physicians /ID# 228282
Schaumburg, Illinois, 60195-3106, United States
Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 228174
Skokie, Illinois, 60076, United States
Springfield Clinic /ID# 228124
Springfield, Illinois, 62702-3749, United States
Beacon Medical Group Clinical Research /ID# 229153
Granger, Indiana, 46530, United States
University of Iowa Hospitals and Clinics /ID# 229217
Iowa City, Iowa, 52242, United States
Four Rivers Clinical Research /ID# 230109
Paducah, Kentucky, 42001, United States
The Arthritis & Diabetes Clinic, Inc. /ID# 228221
Monroe, Louisiana, 71203, United States
Klein and Associates MD /ID# 230145
Cumberland, Maryland, 21502, United States
Klein and Associates MD - Hagerstown /ID# 230143
Hagerstown, Maryland, 21742, United States
The Center for Rheumatology and Bone Research /ID# 228617
Wheaton, Maryland, 20902, United States
AA Medical Research Center - Grand Blanc /ID# 228604
Grand Blanc, Michigan, 48439, United States
Advanced Rheumatology, PC /ID# 228684
Lansing, Michigan, 48910, United States
June DO, PC /ID# 229838
Lansing, Michigan, 48911, United States
Arthritis Associates /ID# 230188
Hattiesburg, Mississippi, 39402, United States
Rheumatology Consultants - Clinical Research /ID# 229208
Tupelo, Mississippi, 38801-4949, United States
Clayton Medical Associates, P.C. dba Saint Louis Rheumatology /ID# 228283
St Louis, Missouri, 63119-3845, United States
West County Rheumatology /ID# 228102
St Louis, Missouri, 63131-1703, United States
Logan Health Research /ID# 228273
Kalispell, Montana, 59901, United States
Advanced Biomedical Research of America /ID# 228596
Las Vegas, Nevada, 89123, United States
Innovative Health Research /ID# 229209
Las Vegas, Nevada, 89128, United States
Arthritis and Osteoporosis Associates /ID# 229418
Freehold, New Jersey, 07728-8307, United States
Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 228602
Voorhees Township, New Jersey, 08043, United States
Albuquerque Center For Rheumatology /ID# 228709
Albuquerque, New Mexico, 87102, United States
Albuquerque Clinical Trials, Inc /ID# 228925
Albuquerque, New Mexico, 87102, United States
Arthritis and Osteo Assoc /ID# 228662
Las Cruces, New Mexico, 88011, United States
Buffalo Rheumatology and Medicine - Orchard Park /ID# 228710
Orchard Park, New York, 14127, United States
St. Lawrence Health System /ID# 229508
Potsdam, New York, 13676, United States
DJL Clinical Research, PLLC /ID# 230133
Charlotte, North Carolina, 28211, United States
Cape Fear Arthritis Care /ID# 228747
Leland, North Carolina, 28451, United States
PMG Research of Salisbury /ID# 230627
Salisbury, North Carolina, 28144, United States
Trinity Health Med Arts Clinic /ID# 228202
Minot, North Dakota, 58701, United States
University of Cincinnati /ID# 229212
Cincinnati, Ohio, 45267-0585, United States
Paramount Medical Research Con /ID# 228254
Middleburg Heights, Ohio, 44130, United States
Arthritis Assoc of NW Ohio /ID# 228936
Toledo, Ohio, 43606, United States
Arthritis and Rheumatology Center of Oklahoma /ID# 228975
Oklahoma City, Oklahoma, 73102, United States
Rheumatology Associates of Oklahoma /ID# 228701
Oklahoma City, Oklahoma, 73116-7226, United States
Advanced Rheumatology & Arthritis Wellness Center /ID# 228608
Cranberry Township, Pennsylvania, 16066, United States
Altoona Ctr Clinical Res /ID# 230058
Duncansville, Pennsylvania, 16635, United States
Arthritis Group /ID# 229777
Philadelphia, Pennsylvania, 19152, United States
PA Regional Center for Arthritis and Osteoporosis Research /ID# 228742
Wyomissing, Pennsylvania, 19610, United States
Columbia Arthritis Center /ID# 228705
Columbia, South Carolina, 29204, United States
West Tennessee Research Institute /ID# 228257
Jackson, Tennessee, 38305, United States
Arthritis and Rheumatology Research Institute, PLLC /ID# 228937
Allen, Texas, 75013-6147, United States
Allen Arthritis /ID# 228712
Allen, Texas, 75013, United States
Trinity Universal Research Associates - Carrollton /ID# 230104
Carrollton, Texas, 75007, United States
Adriana Pop-Moody MD Clinic PA /ID# 230062
Corpus Christi, Texas, 78404, United States
West Texas Clinical Research /ID# 228276
Lubbock, Texas, 79424, United States
P&I Clinical Research /ID# 230183
Lufkin, Texas, 75904-3132, United States
SW Rheumatology Res. LLC /ID# 228088
Mesquite, Texas, 75150, United States
Trinity Universal Research Associates, Inc /ID# 228238
Plano, Texas, 75024-5283, United States
Epic Medical Research /ID# 228097
Red Oak, Texas, 75154-3981, United States
Sun Research Institute /ID# 228768
San Antonio, Texas, 78215, United States
Advanced Rheumatology of Houston /ID# 228170
The Woodlands, Texas, 77382, United States
DM Clinical Research - Tomball /ID# 228112
Tomball, Texas, 77375, United States
Rheumatology Clinic of Houston /ID# 228178
Tomball, Texas, 77377, United States
Arthritis & Osteoporosis Clinic /ID# 228736
Waco, Texas, 76710, United States
Tidewater Physicians Medical Center /ID# 230130
Newport News, Virginia, 23606-4434, United States
Arthritis Northwest, PLLC /ID# 228275
Spokane, Washington, 99204-2302, United States
Emeritus Research Sydney /ID# 230070
Botany, New South Wales, 2019, Australia
BJC Health /ID# 229015
Paramatta, New South Wales, 2150, Australia
Rheumatology Research Unit Sunshine Coast /ID# 229017
Maroochydore, Queensland, 4558, Australia
The Queen Elizabeth Hospital /ID# 230071
Woodville South, South Australia, 5011, Australia
Emeritus Research /ID# 229018
Camberwell, Victoria, 3124, Australia
Rheumatology Research Associates /ID# 227818
Edmonton, Alberta, T5M 0H4, Canada
Manitoba Clinic /ID# 227822
Winnipeg, Manitoba, R3A 1M3, Canada
Groupe de Recherche en Maladies Osseuses Inc /ID# 227821
Sainte-Foy, Quebec, G1V 3M7, Canada
Centre de Recherche Musculo-Squelettique /ID# 227824
Trois-Rivières, Quebec, G8Z 1Y2, Canada
Dr Naik-Medical Professional Corporation-Alliance Health /ID# 227823
Saskatoon, Saskatchewan, S7H 5M7, Canada
Revmatologicky ustav v Praze /ID# 229188
Prague, 128 00, Czechia
PV MEDICAL Services s.r.o. /ID# 228265
Prague, 130 00, Czechia
Revmatologicka ambulance - MUDr. Zuzana Urbanova /ID# 227775
Prague, 140 00, Czechia
Fakultni Nemocnice v Motole /ID# 231622
Prague, 150 06, Czechia
MEDICAL PLUS, s.r.o. /ID# 228030
Uherské Hradiště, 686 01, Czechia
RHEUMA s.r.o. /ID# 230850
Velké Bílovice, 691 02, Czechia
Rheumazentrum Ruhrgebiet /ID# 227850
Herne, North Rhine-Westphalia, 44649, Germany
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 229526
Berlin, 10117, Germany
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 227785
Hamburg, 20095, Germany
General Hospital of Athens Gennimatas /ID# 227806
Athens, Attica, 11527, Greece
University General Hospital of Heraklion PA.G.N.I /ID# 227804
Heraklion, Crete, 71500, Greece
424 General MILITARY Hospital /ID# 227805
Efkarpia (Thessalonikis), Thessaloniki, 56429, Greece
General Hospital of Thessaloniki Hippokrateio /ID# 229614
Thessaloniki, 54642, Greece
Debreceni Egyetem Klinikai Kozpont /ID# 228371
Debrecen, Hajdú-Bihar, 4032, Hungary
Obudai Egeszsegugyi Centrum Kft. /ID# 228359
Budapest, Pest County, 1036, Hungary
DRC Gyogyszervizsgalo Kozpont Kft /ID# 228365
Balatonfüred, 8230, Hungary
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 227671
Budapest, 1023, Hungary
Revita Reumatologiai Rendelo /ID# 227668
Budapest, 1027, Hungary
CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 227670
Székesfehérvár, 8000, Hungary
Vital Medical Center Orvosi es Fogaszati Kozpont (Vital Medicina Kft.) /ID# 227669
Veszprém, 8200, Hungary
Obudai Egeszsegugyi Centrum Kft. Zalaegerszeg /ID# 228374
Zalaegerszeg, 8900, Hungary
Meir Medical Center /ID# 226800
Kfar Saba, Central District, 4428164, Israel
Rambam Health Care Campus /ID# 226798
Haifa, H_efa, 3109601, Israel
Bnai Zion Medical Center /ID# 226801
Haifa, H_efa, 3339419, Israel
The Lady Davis Carmel Medical Center /ID# 226802
Haifa, H_efa, 34362, Israel
The Chaim Sheba Medical Center /ID# 226797
Ramat Gan, Tel Aviv, 5265601, Israel
Tel Aviv Sourasky Medical Center /ID# 228341
Tel Aviv, Tel Aviv, 6423906, Israel
Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 228917
Rome, Lazio, 00128, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 228581
Ancona, 60126, Italy
Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 228583
Palermo, 90127, Italy
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 229899
Nagoya, Aichi-ken, 455-8530, Japan
Daido Clinic /ID# 229280
Nagoya, Aichi-ken, 457-8511, Japan
Sugimoto rheumatology and internal medicine clinic /ID# 229495
Fukui-shi, Fukui, 910-0068, Japan
Hamanomachi Hospital /ID# 228644
Fukuoka, Fukuoka, 810-8539, Japan
National Hospital Organization Kyushu Medical Center /ID# 228642
Fukuoka, Fukuoka, 810-8563, Japan
Shono Rheumatism Clinic /ID# 229054
Fukuoka, Fukuoka, 814-0002, Japan
Katayama Orthopedic Rheumatology Clinic /ID# 229277
Asahikawa-shi, Hokkaido, 078-8243, Japan
Sagawa Akira Rheumatology Clin /ID# 228787
Sapporo, Hokkaido, 060-0001, Japan
Matsubara Mayflower Hospital /ID# 228948
Kato-shi, Hyōgo, 673-1462, Japan
Sanuki Municipal Hospital /ID# 229276
Sanuki-shi, Kagawa-ken, 769-2393, Japan
Bay Side Misato Medical Center /ID# 228947
Kochi, Kochi, 781-0112, Japan
Kumamoto Orthopaedic Hospital /ID# 228641
Kumamoto, Kumamoto, 8620975, Japan
Medical Corporation Keiai Kai Clinic /ID# 228547
Miyazaki, Miyazaki, 880-0053, Japan
Sasebo Chuo Hospital /ID# 229168
Sasebo-shi, Nagasaki, 857-1195, Japan
Nagaoka Red Cross Hospital /ID# 229962
Nagaoka-shi, Niigata, 940-2085, Japan
National Hospital Organization Osaka Minami Medical Center /ID# 229174
Kawachinagano Shi, Osaka, 586-8521, Japan
Osaka City General Hospital /ID# 228786
Osaka, Osaka, 534-0021, Japan
Japanese Red Cross Osaka Hospital /ID# 229816
Osaka, Osaka, 543-8555, Japan
Azuma Rheumatology Clinic /ID# 230078
Sayama-shi, Saitama, 350-1305, Japan
St.Luke's International Hospital /ID# 229492
Chuo-ku, Tokyo, 104-8560, Japan
National Hospital Organization Tokyo Medical Center /ID# 228720
Meguro-ku, Tokyo, 152-8902, Japan
Medical Corporation Uchida Clinic /ID# 229494
Sumida-ku, Tokyo, 130-0013, Japan
Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 228354
Shimonoseki-shi, Yamaguchi, 752-0976, Japan
Academisch Medisch Centrum /ID# 227234
Amsterdam, 1105 AZ, Netherlands
Maastricht Universitair Medisch Centrum /ID# 227235
Maastricht, 6229 HX, Netherlands
Aotearoa Clinical Trials /ID# 229012
Papatoetoe, Auckland, 2025, New Zealand
Timaru Medical Specialists Ltd /ID# 229013
Timaru, Canterbury, 7910, New Zealand
Wellington Regional Hospital /ID# 233517
Newtown, Wellington Region, 6021, New Zealand
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 227939
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland
Centrum Medyczne Reuma Park /ID# 227170
Warsaw, Masovian Voivodeship, 02-691, Poland
SANUS Szpital Specjalistyczny /ID# 227171
Stalowa Wola, Podkarpackie Voivodeship, 37-450, Poland
ClinicMed Daniluk, Nowak Sp.k. /ID# 227919
Bialystok, Podlaskie Voivodeship, 15-879, Poland
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 228047
Gdansk, Pomeranian Voivodeship, 80-546, Poland
MICS Centrum Medyczne Warszawa /ID# 231133
Warsaw, 00-874, Poland
AMICARE Sp. z o.o. sp.k. /ID# 231327
Lodz, Łódź Voivodeship, 90-644, Poland
GCM Medical Group PSC /ID# 228981
San Juan, 00917-3104, Puerto Rico
Mindful Medical Research /ID# 228982
San Juan, 00918-3756, Puerto Rico
LLC Family Outpatient Clinic No /ID# 227926
Korolev, Moscow, 141060, Russia
Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 228755
Moscow, Moscow Oblast, 129110, Russia
Family Clinic /ID# 227929
Yekaterinburg, Sverdlovsk Oblast, 620109, Russia
Kazan State Medical University /ID# 227927
Kazan', Tatarstan, Respublika, 420012, Russia
Central Clinical Hospital of Russian Academy of Science /ID# 229438
Moscow, 117593, Russia
Euromedservice /ID# 227933
Pushkin, 196603, Russia
Clinical Rheumatologic Hospital No 25 /ID# 227922
Saint Petersburg, 190068, Russia
MEDMAN s.r.o. /ID# 227826
Martin, 036 01, Slovakia
Reum.hapi s.r.o. /ID# 227825
Nové Mesto nad Váhom, 915 01, Slovakia
Thermium s.r.o. /ID# 227816
Piešťany, 921 01, Slovakia
REUMAMED POPRAD s.r.o. /ID# 229628
Poprad, 058 01, Slovakia
Reumex, s.r.o. /ID# 227827
Rimavská Sobota, 979 01, Slovakia
SoonChunHyang University CheonAn Hospital /ID# 228146
Cheonan-si, Chungcheongnam-do, 31151, South Korea
Yonsei University Health System Severance Hospital /ID# 227659
Seoul, Seoul Teugbyeolsi, 03722, South Korea
Hanyang University Seoul Hospital /ID# 227658
Seoul, Seoul Teugbyeolsi, 04763, South Korea
Kyungpook National University Hospital /ID# 227657
Daegu, 41944, South Korea
Inha University Hospital /ID# 227656
Incheon, 22332, South Korea
Asan Medical Center /ID# 227655
Seoul, 05505, South Korea
Hospital Clínico Universitario de Santiago-CHUS /ID# 227420
Santiago de Compostela, A Coruna, 15706, Spain
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 227666
Sabadell, Barcelona, 08208, Spain
Hospital Universitario Basurto /ID# 227667
Bilbao, Vizcaya, 48013, Spain
Hospital Universitario A Coruna - CHUAC /ID# 227419
A Coruña, 15006, Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 234115
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre /ID# 227743
Madrid, 28041, Spain
Hospital Regional Universitario de Malaga /ID# 227418
Málaga, 29011, Spain
Hospital Universitario Virgen de Valme /ID# 227417
Seville, 41014, Spain
Hospital Universitario y Politecnico La Fe /ID# 227408
Valencia, 46026, Spain
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 227220
Chiayi City, 62247, Taiwan
Far Eastern Memorial Hospital /ID# 227373
New Taipei City, 22060, Taiwan
National Taiwan University Hospital /ID# 230001
Taipei, 100, Taiwan
Taipei Veterans General Hosp /ID# 227376
Taipei, 11217, Taiwan
Hacettepe Universitesi Tip Fak /ID# 227796
Sihhiye, Ankara, 06100, Turkey (Türkiye)
Ankara Univ Medical Faculty /ID# 227797
Ankara, 06590, Turkey (Türkiye)
Kocaeli University Med Faculty /ID# 228244
Kocaeli, 41380, Turkey (Türkiye)
MNI City Multidisciplinary Hospital #18 Kharkiv City Council /ID# 228961
Kharkiv, 61029, Ukraine
Khmelnytskyi Regional Hospital /ID# 230680
Khmelnytskyi, 29000, Ukraine
Medical Center of Medical Clinic Blagomed LLC /ID# 228956
Kyiv, 01023, Ukraine
Medical Center "OK! Clinic+" LLC, "International Institute of Clinical Research" /ID# 228958
Kyiv, 02091, Ukraine
Medical Center CONSILIUM MEDICAL /ID# 228959
Kyiv, 04050, Ukraine
PI "Poltava Regional Clinical Hospital n.a. M.V.Sklifosovsky of PCC" /ID# 228962
Poltava, 36011, Ukraine
CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 228954
Vinnytsia, 21018, Ukraine
Сlinic Scientific Research Inst of Invalid Rehab ESMС M I Pyrogov VNMU /ID# 228955
Vinnytsia, 21029, Ukraine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2021
First Posted
May 17, 2021
Study Start
June 23, 2021
Primary Completion
August 25, 2022
Study Completion
August 4, 2023
Last Updated
October 8, 2024
Results First Posted
October 8, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- 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/
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.