Back to resultsStudy 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)
Primary Purpose
Rheumatoid Arthritis (RA)
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ABBV-154
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis (RA) focused on measuring Rheumatoid Arthritis (RA), ABBV-154, AIM-RA
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of rheumatoid arthritis(RA) with fulfillment of the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA.
- Participant has >= 6 swollen joints (based on 66 joint count) and >=6 tender joints (based on 68 joint count) at baseline.
- Participant must have had an inadequate response to at least one prior biologic and/or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) treatment for RA.
- Participants must be on stable dose of methotrexate (MTX).
Exclusion Criteria:
- Participant discontinued prior adalimumab therapy due to intolerability or toxicity.
Sites / Locations
- Elite Clinical Studies, LLC /ID# 228227
- Arthritis and Rheumatism Associates /ID# 228201
- Providence Medical Foundation /ID# 228104
- Care Access Research, Huntington Beach /ID# 228163
- San Diego Rheumatology /ID# 228120
- Arthritis & Osteo Medical Ctr /ID# 228239
- Pacific Arthritis Care Center - Los Angeles /ID# 229330
- California Medical Research Associates /ID# 230131
- Arthritis Care And Research Center ACRC /ID# 230099
- East Bay Rheumatology Medical /ID# 228099
- Millennium Clinical Trials /ID# 230618
- The Lundquist Institute at Harbor-UCLA Medical Center /ID# 228241
- Medvin Clinical Research /ID# 228181
- Inland Rheum & Osteo Med Grp /ID# 228204
- Comprehensive Rheumatology Center /ID# 230132
- Denver Arthritis Clinic /ID# 228172
- New England Research Associates, LLC /ID# 230127
- Stamford Therapeutics Consorti /ID# 229214
- Delaware Arthritis /ID# 229413
- Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 228229
- Bay Area Arthritis and Osteo /ID# 228075
- Clinical Research of West Florida, Inc /ID# 228128
- International Medical Research - Daytona /ID# 228069
- Omega Research Debary, LLC /ID# 228293
- Sweet Hope Research Specialty Inc /ID# 228753
- University of Florida /ID# 228242
- Lakes Research, LLC /ID# 228665
- University of Miami /ID# 228737
- Suncoast Clinical Research /ID# 228237
- Omega Research Maitland, LLC /ID# 229966
- HMD Research LLC /ID# 228185
- Millennium Research /ID# 228183
- Arthritis Center, Inc. /ID# 228209
- BayCare Medical Group /ID# 228289
- West Broward Rheumatology Associates /ID# 228603
- Clinical Research of West Florida - Tampa /ID# 228186
- Conquest Research /ID# 230560
- Florida Medical Clinic /ID# 228236
- Arthritis and Rheumatology /ID# 228743
- Jefrey D. Lieberman, MD, P.C. /ID# 230129
- Arthritis Center of North GA /ID# 228769
- Atlanta Research Center for Rheumatology /ID# 230430
- Great Lakes Clinical Trials /ID# 228699
- Greater Chicago Specialty Physicians /ID# 228282
- Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 228174
- Springfield Clinic /ID# 228124
- Beacon Medical Group Clinical Research /ID# 229153
- University of Iowa Hospitals and Clinics /ID# 229217
- Four Rivers Clinical Research /ID# 230109
- The Arthritis & Diabetes Clinic, Inc. /ID# 228221
- Klein and Associates MD /ID# 230145
- Klein and Associates MD - Hagerstown /ID# 230143
- The Center for Rheumatology and Bone Research /ID# 228617
- AA Medical Research Center - Grand Blanc /ID# 228604
- Advanced Rheumatology, PC /ID# 228684
- June DO, PC /ID# 229838
- Arthritis Associates /ID# 230188
- Rheumatology Consultants - Clinical Research /ID# 229208
- Clayton Medical Associates, P.C. dba Saint Louis Rheumatology /ID# 228283
- West County Rheumatology /ID# 228102
- Logan Health Research /ID# 228273
- Advanced Biomedical Research of America /ID# 228596
- Innovative Health Research /ID# 229209
- Arthritis and Osteoporosis Associates /ID# 229418
- Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 228602
- Albuquerque Center For Rheumatology /ID# 228709
- Albuquerque Clinical Trials, Inc /ID# 228925
- Arthritis and Osteo Assoc /ID# 228662
- Buffalo Rheumatology and Medicine - Orchard Park /ID# 228710
- St. Lawrence Health System /ID# 229508
- DJL Clinical Research, PLLC /ID# 230133
- Cape Fear Arthritis Care /ID# 228747
- PMG Research of Salisbury /ID# 230627
- Trinity Health Med Arts Clinic /ID# 228202
- University of Cincinnati /ID# 229212
- Paramount Medical Research Con /ID# 228254
- Arthritis Assoc of NW Ohio /ID# 228936
- Arthritis and Rheumatology Center of Oklahoma /ID# 228975
- Rheumatology Associates of Oklahoma /ID# 228701
- Advanced Rheumatology & Arthritis Wellness Center /ID# 228608
- Altoona Ctr Clinical Res /ID# 230058
- Arthritis Group /ID# 229777
- PA Regional Center for Arthritis and Osteoporosis Research /ID# 228742
- Columbia Arthritis Center /ID# 228705
- West Tennessee Research Institute /ID# 228257
- Arthritis and Rheumatology Research Institute, PLLC /ID# 228937
- Allen Arthritis /ID# 228712
- Trinity Universal Research Associates - Carrollton /ID# 230104
- Adriana Pop-Moody MD Clinic PA /ID# 230062
- Rheumatology Clinic of Houston /ID# 228178
- West Texas Clinical Research /ID# 228276
- P&I Clinical Research /ID# 230183
- SW Rheumatology Res. LLC /ID# 228088
- Trinity Universal Research Associates, Inc /ID# 228238
- Epic Medical Research /ID# 228097
- Sun Research Institute /ID# 228768
- Advanced Rheumatology of Houston /ID# 228170
- DM Clinical Research - Tomball /ID# 228112
- Arthritis & Osteoporosis Clinic /ID# 228736
- Tidewater Physicians Medical Center /ID# 230130
- Arthritis Northwest, PLLC /ID# 228275
- Emeritus Research Sydney /ID# 230070
- BJC Health /ID# 229015
- Rheumatology Research Unit Sunshine Coast /ID# 229017
- The Queen Elizabeth Hospital /ID# 230071
- Emeritus Research /ID# 229018
- Rheumatology Research Associates /ID# 227818
- Manitoba Clinic /ID# 227822
- Groupe de Recherche en Maladies Osseuses Inc /ID# 227821
- Centre de Recherche Musculo-Squelettique /ID# 227824
- Dr. Latha Naik /ID# 227823
- Revmatologicky ustav v Praze /ID# 229188
- PV MEDICAL Services s.r.o. /ID# 228265
- Revmatologicka ambulance - MUDr. Zuzana Urbanova /ID# 227775
- Fakultni Nemocnice v Motole /ID# 231622
- MEDICAL PLUS, s.r.o. /ID# 228030
- RHEUMA s.r.o. /ID# 230850
- Rheumazentrum Ruhrgebiet /ID# 227850
- Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 229526
- MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 227785
- General Hospital of Athens Gennimatas /ID# 227806
- University General Hospital of Heraklion PA.G.N.I /ID# 227804
- 424 General MILITARY Hospital /ID# 227805
- General Hospital of Thessaloniki Hippokrateio /ID# 229614
- Debreceni Egyetem Klinikai Kozpont /ID# 228371
- Obudai Egeszsegugyi Centrum Kft. /ID# 228359
- DRC Gyogyszervizsgalo Kozpont Kft /ID# 228365
- Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 227671
- Revita Reumatologiai Rendelo /ID# 227668
- CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 227670
- Vital Medical Center Orvosi es Fogaszati Kozpont (Vital Medicina Kft.) /ID# 227669
- Obudai Egeszsegugyi Centrum Kft. Zalaegerszeg /ID# 228374
- The Chaim Sheba Medical Center /ID# 226797
- Tel Aviv Sourasky Medical Center /ID# 228341
- Rambam Health Care Campus /ID# 226798
- Bnai Zion Medical Center /ID# 226801
- The Lady Davis Carmel Medical Center /ID# 226802
- Meir Medical Center /ID# 226800
- Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 228917
- Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 228581
- Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 228583
- Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 229899
- Daido Clinic /ID# 229280
- Sugimoto rheumatology and internal medicine clinic /ID# 229495
- National Hospital Organization Kyushu Medical Center /ID# 228642
- Hamanomachi Hospital /ID# 228644
- Shono Rheumatism Clinic /ID# 229054
- Katayama Orthopedic Rheumatology Clinic /ID# 229277
- Sagawa Akira Rheumatology Clin /ID# 228787
- Matsubara Mayflower Hospital /ID# 228948
- Sanuki Municipal Hospital /ID# 229276
- Bay Side Misato Medical Center /ID# 228947
- Kumamoto Orthopaedic Hospital /ID# 228641
- Medical Corporation Keiai Kai Clinic /ID# 228547
- Sasebo Chuo Hospital /ID# 229168
- Nagaoka Red Cross Hospital /ID# 229962
- National Hospital Organization Osaka Minami Medical Center /ID# 229174
- Osaka City General Hospital /ID# 228786
- Japanese Red Cross Osaka Hospital /ID# 229816
- Azuma Rheumatology Clinic /ID# 230078
- St.Luke's International Hospital /ID# 229492
- National Hospital Organization Tokyo Medical Center /ID# 228720
- Medical Corporation Uchida Clinic /ID# 229494
- Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 228354
- SoonChunHyang University CheonAn Hospital /ID# 228146
- Yonsei University Health System Severance Hospital /ID# 227659
- Hanyang University Seoul Hospital /ID# 227658
- Kyungpook National University Hospital /ID# 227657
- Inha University Hospital /ID# 227656
- Asan Medical Center /ID# 227655
- Academisch Medisch Centrum /ID# 227234
- Maastricht Universitair Medisch Centrum /ID# 227235
- Middlemore Clinical Trials /ID# 229012
- Timaru Medical Specialists Ltd /ID# 229013
- Wellington Regional Hospital /ID# 233517
- Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 227939
- AMICARE Sp. z o.o. sp.k. /ID# 231327
- Centrum Medyczne Reuma Park /ID# 227170
- SANUS Szpital Specjalistyczny /ID# 227171
- ClinicMed Daniluk, Nowak Sp.j. /ID# 227919
- Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 228047
- Medycyna Kliniczna /ID# 231133
- GCM Medical Group PSC /ID# 228981
- Mindful Medical Research /ID# 228982
- Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 228755
- LLC Family Outpatient Clinic No /ID# 227926
- Family Clinic /ID# 227929
- Kazan State Medical University /ID# 227927
- Central Clinical Hospital of Russian Academy of Science /ID# 229438
- Euromedservice /ID# 227933
- Clinical Rheumatologic Hospital No 25 /ID# 227922
- MEDMAN s.r.o. /ID# 227826
- Reum.hapi s.r.o. /ID# 227825
- Thermium s.r.o. /ID# 227816
- REUMAMED POPRAD s.r.o. /ID# 229628
- Reumex, s.r.o. /ID# 227827
- Hospital Clínico Universitario de Santiago-CHUS /ID# 227420
- Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 227666
- Hospital Regional de Malaga /ID# 227418
- Hospital Universitario Basurto /ID# 227667
- Hospital Universitario A Coruna - CHUAC /ID# 227419
- Hospital Universitario Fundacion Jimenez Diaz /ID# 234115
- Hospital Universitario 12 de Octubre /ID# 227743
- Hospital Universitario Virgen de Valme /ID# 227417
- Hospital Universitario y Politecnico La Fe /ID# 227408
- Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 227220
- Far Eastern Memorial Hospital /ID# 227373
- National Taiwan University Hospital /ID# 230001
- Taipei Veterans General Hosp /ID# 227376
- Hacettepe Universitesi Tip Fak /ID# 227796
- Ankara Univ Medical Faculty /ID# 227797
- Kocaeli University Med Faculty /ID# 228244
- MNI City Multidisciplinary Hospital #18 /ID# 228961
- Khmelnytskyi Regional Hospital /ID# 230680
- Medical Center of Medical Clinic Blagomed LLC /ID# 228956
- Medical Center "OK!Clinic+" /ID# 228958
- Medical Center CONSILIUM MEDICAL /ID# 228959
- PI "Poltava Regional Clinical Hospital n.a. M.V.Sklifosovsky" /ID# 228962
- CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 228954
- Clinic of Scientific Research Institute of Invalid Rehabilitation /ID# 228955
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Dose A of ABBV-154
Dose B of ABBV-154
Dose C of ABBV-154 EOW
Dose C of ABBV-154 E4W
Placebo
Arm Description
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.
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Percentage of Participants Achieving American College of Rheumatology 50 % (ACR50) Response
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 measured on a Numerical Rating Scale of 0 to 10 (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).
Secondary Outcome Measures
Change in Disease Activity Score (DAS) 28 (CRP) from Baseline
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.
Change in Clinical Disease Activity Index (CDAI) from Baseline
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.
Percentage of Participants Achieving American College of Rheumatology 20 % (ACR20) Response
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).
Percentage of Participants Achieving American College of Rheumatology 70 % (ACR70) Response
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).
Percentage of Participants Achieving Low Disease Activity (LDA) Defined by DAS28 (CRP) <= 3.2
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.
Percentage of Participants Achieving LDA Defined by CDAI <= 10
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.
Percentage of Participants Achieving Clinical Remission (CR) Defined by DAS28 (CRP) < 2.6
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.
Percentage of Participants Achieving CR Defined by CDAI <= 2.8
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.
Change in the Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04888585
Brief Title
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)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Business decision
Study Start Date
June 2, 2021 (Actual)
Primary Completion Date
August 25, 2022 (Actual)
Study Completion Date
August 4, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Rheumatoid Arthritis (RA) is an inflammatory disease of the joints causing pain, stiffness, swelling and loss of joint function. This study evaluates how safe and effective ABBV-154 is in participants treated for moderately to severely active RA. Adverse events and change in the disease activity will be assessed.
ABBV-154 is an investigational drug being evaluated for the treatment of RA. Study doctors place the participants in 1 of 5 treatment groups or arms, each arm receiving a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. Participants 18-75 years of age with moderate to severe RA will be enrolled. Around 425 participants will be enrolled in the study in approximately 270 sites worldwide.
The study is 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 will be re-randomized to receive ABBV-154 in 2 different doses SC every other week (eow). Other participants will remain on their previous dose and dosing regimen of ABBV-154.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis (RA)
Keywords
Rheumatoid Arthritis (RA), ABBV-154, AIM-RA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
473 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose A of ABBV-154
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose B of ABBV-154
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose C of ABBV-154 EOW
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose C of ABBV-154 E4W
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ABBV-154
Intervention Description
Subcutaneous Injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous Injection
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving American College of Rheumatology 50 % (ACR50) Response
Description
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 measured on a Numerical Rating Scale of 0 to 10 (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).
Time Frame
At 12 weeks
Secondary Outcome Measure Information:
Title
Change in Disease Activity Score (DAS) 28 (CRP) from Baseline
Description
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.
Time Frame
Up to 12 weeks
Title
Change in Clinical Disease Activity Index (CDAI) from Baseline
Description
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.
Time Frame
Up to 12 weeks
Title
Percentage of Participants Achieving American College of Rheumatology 20 % (ACR20) Response
Description
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).
Time Frame
At 12 weeks
Title
Percentage of Participants Achieving American College of Rheumatology 70 % (ACR70) Response
Description
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).
Time Frame
At 12 weeks
Title
Percentage of Participants Achieving Low Disease Activity (LDA) Defined by DAS28 (CRP) <= 3.2
Description
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.
Time Frame
At 12 weeks
Title
Percentage of Participants Achieving LDA Defined by CDAI <= 10
Description
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.
Time Frame
At 12 weeks
Title
Percentage of Participants Achieving Clinical Remission (CR) Defined by DAS28 (CRP) < 2.6
Description
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.
Time Frame
At 12 weeks
Title
Percentage of Participants Achieving CR Defined by CDAI <= 2.8
Description
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.
Time Frame
At 12 weeks
Title
Change in the Health Assessment Questionnaire Disability Index (HAQ-DI) From Baseline
Description
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.
Time Frame
Up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of rheumatoid arthritis(RA) with fulfillment of the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA.
Participant has >= 6 swollen joints (based on 66 joint count) and >=6 tender joints (based on 68 joint count) at baseline.
Participant must have had an inadequate response to at least one prior biologic and/or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) treatment for RA.
Participants must be on stable dose of methotrexate (MTX).
Exclusion Criteria:
- Participant discontinued prior adalimumab therapy due to intolerability or toxicity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Elite Clinical Studies, LLC /ID# 228227
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Arthritis and Rheumatism Associates /ID# 228201
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401-6251
Country
United States
Facility Name
Providence Medical Foundation /ID# 228104
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Care Access Research, Huntington Beach /ID# 228163
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
San Diego Rheumatology /ID# 228120
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Arthritis & Osteo Medical Ctr /ID# 228239
City
La Palma
State/Province
California
ZIP/Postal Code
90623-1728
Country
United States
Facility Name
Pacific Arthritis Care Center - Los Angeles /ID# 229330
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045-6200
Country
United States
Facility Name
California Medical Research Associates /ID# 230131
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Facility Name
Arthritis Care And Research Center ACRC /ID# 230099
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
East Bay Rheumatology Medical /ID# 228099
City
San Leandro
State/Province
California
ZIP/Postal Code
94578
Country
United States
Facility Name
Millennium Clinical Trials /ID# 230618
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360-3951
Country
United States
Facility Name
The Lundquist Institute at Harbor-UCLA Medical Center /ID# 228241
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Medvin Clinical Research /ID# 228181
City
Tujunga
State/Province
California
ZIP/Postal Code
91042-2706
Country
United States
Facility Name
Inland Rheum & Osteo Med Grp /ID# 228204
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Comprehensive Rheumatology Center /ID# 230132
City
West Hills
State/Province
California
ZIP/Postal Code
91307-2003
Country
United States
Facility Name
Denver Arthritis Clinic /ID# 228172
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
New England Research Associates, LLC /ID# 230127
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606-1827
Country
United States
Facility Name
Stamford Therapeutics Consorti /ID# 229214
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Delaware Arthritis /ID# 229413
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 228229
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Bay Area Arthritis and Osteo /ID# 228075
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Clinical Research of West Florida, Inc /ID# 228128
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
International Medical Research - Daytona /ID# 228069
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Omega Research Debary, LLC /ID# 228293
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713-2260
Country
United States
Facility Name
Sweet Hope Research Specialty Inc /ID# 228753
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016-1897
Country
United States
Facility Name
University of Florida /ID# 228242
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Lakes Research, LLC /ID# 228665
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
University of Miami /ID# 228737
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Suncoast Clinical Research /ID# 228237
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Omega Research Maitland, LLC /ID# 229966
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Facility Name
HMD Research LLC /ID# 228185
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Millennium Research /ID# 228183
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Arthritis Center, Inc. /ID# 228209
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
BayCare Medical Group /ID# 228289
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
West Broward Rheumatology Associates /ID# 228603
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Clinical Research of West Florida - Tampa /ID# 228186
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606-1246
Country
United States
Facility Name
Conquest Research /ID# 230560
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Florida Medical Clinic /ID# 228236
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Arthritis and Rheumatology /ID# 228743
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Jefrey D. Lieberman, MD, P.C. /ID# 230129
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Arthritis Center of North GA /ID# 228769
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Atlanta Research Center for Rheumatology /ID# 230430
City
Marietta
State/Province
Georgia
ZIP/Postal Code
20060
Country
United States
Facility Name
Great Lakes Clinical Trials /ID# 228699
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Facility Name
Greater Chicago Specialty Physicians /ID# 228282
City
Schaumburg
State/Province
Illinois
ZIP/Postal Code
60195-3106
Country
United States
Facility Name
Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 228174
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Springfield Clinic /ID# 228124
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702-3749
Country
United States
Facility Name
Beacon Medical Group Clinical Research /ID# 229153
City
Granger
State/Province
Indiana
ZIP/Postal Code
46530
Country
United States
Facility Name
University of Iowa Hospitals and Clinics /ID# 229217
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Four Rivers Clinical Research /ID# 230109
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States
Facility Name
The Arthritis & Diabetes Clinic, Inc. /ID# 228221
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Facility Name
Klein and Associates MD /ID# 230145
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Klein and Associates MD - Hagerstown /ID# 230143
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
Facility Name
The Center for Rheumatology and Bone Research /ID# 228617
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
AA Medical Research Center - Grand Blanc /ID# 228604
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
Advanced Rheumatology, PC /ID# 228684
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
June DO, PC /ID# 229838
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Arthritis Associates /ID# 230188
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39402
Country
United States
Facility Name
Rheumatology Consultants - Clinical Research /ID# 229208
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801-4949
Country
United States
Facility Name
Clayton Medical Associates, P.C. dba Saint Louis Rheumatology /ID# 228283
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63119-3845
Country
United States
Facility Name
West County Rheumatology /ID# 228102
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131-1703
Country
United States
Facility Name
Logan Health Research /ID# 228273
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Advanced Biomedical Research of America /ID# 228596
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Innovative Health Research /ID# 229209
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Arthritis and Osteoporosis Associates /ID# 229418
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728-8307
Country
United States
Facility Name
Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 228602
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Albuquerque Center For Rheumatology /ID# 228709
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc /ID# 228925
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Arthritis and Osteo Assoc /ID# 228662
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011
Country
United States
Facility Name
Buffalo Rheumatology and Medicine - Orchard Park /ID# 228710
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
Facility Name
St. Lawrence Health System /ID# 229508
City
Potsdam
State/Province
New York
ZIP/Postal Code
13676
Country
United States
Facility Name
DJL Clinical Research, PLLC /ID# 230133
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210-8508
Country
United States
Facility Name
Cape Fear Arthritis Care /ID# 228747
City
Leland
State/Province
North Carolina
ZIP/Postal Code
28451
Country
United States
Facility Name
PMG Research of Salisbury /ID# 230627
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Trinity Health Med Arts Clinic /ID# 228202
City
Minot
State/Province
North Dakota
ZIP/Postal Code
58701
Country
United States
Facility Name
University of Cincinnati /ID# 229212
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0585
Country
United States
Facility Name
Paramount Medical Research Con /ID# 228254
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Arthritis Assoc of NW Ohio /ID# 228936
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Arthritis and Rheumatology Center of Oklahoma /ID# 228975
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73102
Country
United States
Facility Name
Rheumatology Associates of Oklahoma /ID# 228701
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116-7226
Country
United States
Facility Name
Advanced Rheumatology & Arthritis Wellness Center /ID# 228608
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Altoona Ctr Clinical Res /ID# 230058
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Arthritis Group /ID# 229777
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
Facility Name
PA Regional Center for Arthritis and Osteoporosis Research /ID# 228742
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Columbia Arthritis Center /ID# 228705
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
West Tennessee Research Institute /ID# 228257
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Arthritis and Rheumatology Research Institute, PLLC /ID# 228937
City
Allen
State/Province
Texas
ZIP/Postal Code
75013-6147
Country
United States
Facility Name
Allen Arthritis /ID# 228712
City
Allen
State/Province
Texas
ZIP/Postal Code
75013
Country
United States
Facility Name
Trinity Universal Research Associates - Carrollton /ID# 230104
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Facility Name
Adriana Pop-Moody MD Clinic PA /ID# 230062
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Facility Name
Rheumatology Clinic of Houston /ID# 228178
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Facility Name
West Texas Clinical Research /ID# 228276
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410-1198
Country
United States
Facility Name
P&I Clinical Research /ID# 230183
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904-3132
Country
United States
Facility Name
SW Rheumatology Res. LLC /ID# 228088
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Trinity Universal Research Associates, Inc /ID# 228238
City
Plano
State/Province
Texas
ZIP/Postal Code
75024-5283
Country
United States
Facility Name
Epic Medical Research /ID# 228097
City
Red Oak
State/Province
Texas
ZIP/Postal Code
75154-3981
Country
United States
Facility Name
Sun Research Institute /ID# 228768
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Advanced Rheumatology of Houston /ID# 228170
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77382
Country
United States
Facility Name
DM Clinical Research - Tomball /ID# 228112
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Arthritis & Osteoporosis Clinic /ID# 228736
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Facility Name
Tidewater Physicians Medical Center /ID# 230130
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606-4434
Country
United States
Facility Name
Arthritis Northwest, PLLC /ID# 228275
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204-2302
Country
United States
Facility Name
Emeritus Research Sydney /ID# 230070
City
Botany
State/Province
New South Wales
ZIP/Postal Code
2019
Country
Australia
Facility Name
BJC Health /ID# 229015
City
Paramatta
State/Province
New South Wales
ZIP/Postal Code
2150
Country
Australia
Facility Name
Rheumatology Research Unit Sunshine Coast /ID# 229017
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
The Queen Elizabeth Hospital /ID# 230071
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Emeritus Research /ID# 229018
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
Rheumatology Research Associates /ID# 227818
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5M 0H4
Country
Canada
Facility Name
Manitoba Clinic /ID# 227822
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
Country
Canada
Facility Name
Groupe de Recherche en Maladies Osseuses Inc /ID# 227821
City
Sainte-foy
State/Province
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Centre de Recherche Musculo-Squelettique /ID# 227824
City
Trois-rivières
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
Facility Name
Dr. Latha Naik /ID# 227823
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 3H3
Country
Canada
Facility Name
Revmatologicky ustav v Praze /ID# 229188
City
Praha
ZIP/Postal Code
128 00
Country
Czechia
Facility Name
PV MEDICAL Services s.r.o. /ID# 228265
City
Praha
ZIP/Postal Code
130 00
Country
Czechia
Facility Name
Revmatologicka ambulance - MUDr. Zuzana Urbanova /ID# 227775
City
Praha
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Fakultni Nemocnice v Motole /ID# 231622
City
Praha
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
MEDICAL PLUS, s.r.o. /ID# 228030
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
RHEUMA s.r.o. /ID# 230850
City
Velke Bilovice
ZIP/Postal Code
691 02
Country
Czechia
Facility Name
Rheumazentrum Ruhrgebiet /ID# 227850
City
Herne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44649
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 229526
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 227785
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Facility Name
General Hospital of Athens Gennimatas /ID# 227806
City
Athens
State/Province
Attiki
ZIP/Postal Code
11527
Country
Greece
Facility Name
University General Hospital of Heraklion PA.G.N.I /ID# 227804
City
Heraklion
State/Province
Kriti
ZIP/Postal Code
71500
Country
Greece
Facility Name
424 General MILITARY Hospital /ID# 227805
City
Efkarpia (Thessalonikis)
State/Province
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
Facility Name
General Hospital of Thessaloniki Hippokrateio /ID# 229614
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Facility Name
Debreceni Egyetem Klinikai Kozpont /ID# 228371
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Obudai Egeszsegugyi Centrum Kft. /ID# 228359
City
Budapest
State/Province
Pest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
DRC Gyogyszervizsgalo Kozpont Kft /ID# 228365
City
Balatonfüred
ZIP/Postal Code
8230
Country
Hungary
Facility Name
Betegapolo Irgalmasrend Budai Irgalmasrendi Korhaz /ID# 227671
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Revita Reumatologiai Rendelo /ID# 227668
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 227670
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Vital Medical Center Orvosi es Fogaszati Kozpont (Vital Medicina Kft.) /ID# 227669
City
Veszprém
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Obudai Egeszsegugyi Centrum Kft. Zalaegerszeg /ID# 228374
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
The Chaim Sheba Medical Center /ID# 226797
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center /ID# 228341
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Rambam Health Care Campus /ID# 226798
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Bnai Zion Medical Center /ID# 226801
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Facility Name
The Lady Davis Carmel Medical Center /ID# 226802
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Meir Medical Center /ID# 226800
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 228917
City
Rome
State/Province
Lazio
ZIP/Postal Code
00128
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 228581
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 228583
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Japan Organization of Occupational Health and Safety Chubu Rosai Hospital /ID# 229899
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
455-8530
Country
Japan
Facility Name
Daido Clinic /ID# 229280
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
Sugimoto rheumatology and internal medicine clinic /ID# 229495
City
Fukui-shi
State/Province
Fukui
ZIP/Postal Code
910-0068
Country
Japan
Facility Name
National Hospital Organization Kyushu Medical Center /ID# 228642
City
Fukuoka shi
State/Province
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
Hamanomachi Hospital /ID# 228644
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
810-8539
Country
Japan
Facility Name
Shono Rheumatism Clinic /ID# 229054
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
814-0002
Country
Japan
Facility Name
Katayama Orthopedic Rheumatology Clinic /ID# 229277
City
Asahikawa-shi
State/Province
Hokkaido
ZIP/Postal Code
078-8243
Country
Japan
Facility Name
Sagawa Akira Rheumatology Clin /ID# 228787
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0001
Country
Japan
Facility Name
Matsubara Mayflower Hospital /ID# 228948
City
Kato-shi
State/Province
Hyogo
ZIP/Postal Code
673-1462
Country
Japan
Facility Name
Sanuki Municipal Hospital /ID# 229276
City
Sanuki-shi
State/Province
Kagawa
ZIP/Postal Code
769-2393
Country
Japan
Facility Name
Bay Side Misato Medical Center /ID# 228947
City
Kochi-shi
State/Province
Kochi
ZIP/Postal Code
781-0112
Country
Japan
Facility Name
Kumamoto Orthopaedic Hospital /ID# 228641
City
Kumamoto shi
State/Province
Kumamoto
ZIP/Postal Code
8620975
Country
Japan
Facility Name
Medical Corporation Keiai Kai Clinic /ID# 228547
City
Miyazaki-shi
State/Province
Miyazaki
ZIP/Postal Code
880-0053
Country
Japan
Facility Name
Sasebo Chuo Hospital /ID# 229168
City
Sasebo-shi
State/Province
Nagasaki
ZIP/Postal Code
857-1195
Country
Japan
Facility Name
Nagaoka Red Cross Hospital /ID# 229962
City
Nagaoka-shi
State/Province
Niigata
ZIP/Postal Code
940-2085
Country
Japan
Facility Name
National Hospital Organization Osaka Minami Medical Center /ID# 229174
City
Kawachinagano Shi
State/Province
Osaka
ZIP/Postal Code
586-8521
Country
Japan
Facility Name
Osaka City General Hospital /ID# 228786
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Japanese Red Cross Osaka Hospital /ID# 229816
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
543-8555
Country
Japan
Facility Name
Azuma Rheumatology Clinic /ID# 230078
City
Sayama-shi
State/Province
Saitama
ZIP/Postal Code
350-1305
Country
Japan
Facility Name
St.Luke's International Hospital /ID# 229492
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
National Hospital Organization Tokyo Medical Center /ID# 228720
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
Facility Name
Medical Corporation Uchida Clinic /ID# 229494
City
Sumida-ku
State/Province
Tokyo
ZIP/Postal Code
130-0013
Country
Japan
Facility Name
Tokito Clinic Rheumatology and Orthopaedics Surgery /ID# 228354
City
Shimonoseki-shi
State/Province
Yamaguchi
ZIP/Postal Code
752-0976
Country
Japan
Facility Name
SoonChunHyang University CheonAn Hospital /ID# 228146
City
Cheonan-si
State/Province
Chungcheongnamdo
ZIP/Postal Code
31151
Country
Korea, Republic of
Facility Name
Yonsei University Health System Severance Hospital /ID# 227659
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Hanyang University Seoul Hospital /ID# 227658
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital /ID# 227657
City
Daegu
ZIP/Postal Code
41944
Country
Korea, Republic of
Facility Name
Inha University Hospital /ID# 227656
City
Incheon
ZIP/Postal Code
22332
Country
Korea, Republic of
Facility Name
Asan Medical Center /ID# 227655
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Academisch Medisch Centrum /ID# 227234
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Maastricht Universitair Medisch Centrum /ID# 227235
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Middlemore Clinical Trials /ID# 229012
City
Papatoetoe
State/Province
Auckland
ZIP/Postal Code
2025
Country
New Zealand
Facility Name
Timaru Medical Specialists Ltd /ID# 229013
City
Timaru
State/Province
Canterbury
ZIP/Postal Code
7910
Country
New Zealand
Facility Name
Wellington Regional Hospital /ID# 233517
City
Newtown
State/Province
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 227939
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-168
Country
Poland
Facility Name
AMICARE Sp. z o.o. sp.k. /ID# 231327
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-644
Country
Poland
Facility Name
Centrum Medyczne Reuma Park /ID# 227170
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-691
Country
Poland
Facility Name
SANUS Szpital Specjalistyczny /ID# 227171
City
Stalowa Wola
State/Province
Podkarpackie
ZIP/Postal Code
37-450
Country
Poland
Facility Name
ClinicMed Daniluk, Nowak Sp.j. /ID# 227919
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Centrum Badan Klinicznych PI-House sp. z o.o. /ID# 228047
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Medycyna Kliniczna /ID# 231133
City
Warsaw
ZIP/Postal Code
00-874
Country
Poland
Facility Name
GCM Medical Group PSC /ID# 228981
City
San Juan
ZIP/Postal Code
00917-3104
Country
Puerto Rico
Facility Name
Mindful Medical Research /ID# 228982
City
San Juan
ZIP/Postal Code
00918-3756
Country
Puerto Rico
Facility Name
Moscow Regional Research and Clinical Institute n.a. Vladimirskiy (MONIKI) /ID# 228755
City
Moscow
State/Province
Moskovskaya Oblast
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
LLC Family Outpatient Clinic No /ID# 227926
City
Korolev
State/Province
Moskva
ZIP/Postal Code
141060
Country
Russian Federation
Facility Name
Family Clinic /ID# 227929
City
Yekaterinburg
State/Province
Sverdlovskaya Oblast
ZIP/Postal Code
620109
Country
Russian Federation
Facility Name
Kazan State Medical University /ID# 227927
City
Kazan
State/Province
Tatarstan, Respublika
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Central Clinical Hospital of Russian Academy of Science /ID# 229438
City
Moscow
ZIP/Postal Code
117593
Country
Russian Federation
Facility Name
Euromedservice /ID# 227933
City
Pushkin
ZIP/Postal Code
196603
Country
Russian Federation
Facility Name
Clinical Rheumatologic Hospital No 25 /ID# 227922
City
St. Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Facility Name
MEDMAN s.r.o. /ID# 227826
City
Martin
ZIP/Postal Code
036 01
Country
Slovakia
Facility Name
Reum.hapi s.r.o. /ID# 227825
City
Nove Mesto nad Vahom
ZIP/Postal Code
915 01
Country
Slovakia
Facility Name
Thermium s.r.o. /ID# 227816
City
Piestany
ZIP/Postal Code
921 01
Country
Slovakia
Facility Name
REUMAMED POPRAD s.r.o. /ID# 229628
City
Poprad
ZIP/Postal Code
058 01
Country
Slovakia
Facility Name
Reumex, s.r.o. /ID# 227827
City
Rimavska Sobota
ZIP/Postal Code
979 01
Country
Slovakia
Facility Name
Hospital Clínico Universitario de Santiago-CHUS /ID# 227420
City
Santiago de Compostela
State/Province
A Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 227666
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Regional de Malaga /ID# 227418
City
Málaga
State/Province
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Basurto /ID# 227667
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital Universitario A Coruna - CHUAC /ID# 227419
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Universitario Fundacion Jimenez Diaz /ID# 234115
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre /ID# 227743
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario Virgen de Valme /ID# 227417
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 227408
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 227220
City
Chia-Yi
ZIP/Postal Code
62247
Country
Taiwan
Facility Name
Far Eastern Memorial Hospital /ID# 227373
City
New Taipei City
ZIP/Postal Code
22060
Country
Taiwan
Facility Name
National Taiwan University Hospital /ID# 230001
City
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Taipei Veterans General Hosp /ID# 227376
City
Taipei City
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Hacettepe Universitesi Tip Fak /ID# 227796
City
Sihhiye
State/Province
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Ankara Univ Medical Faculty /ID# 227797
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Facility Name
Kocaeli University Med Faculty /ID# 228244
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
MNI City Multidisciplinary Hospital #18 /ID# 228961
City
Kharkiv
ZIP/Postal Code
61110
Country
Ukraine
Facility Name
Khmelnytskyi Regional Hospital /ID# 230680
City
Khmelnytskyi
ZIP/Postal Code
29000
Country
Ukraine
Facility Name
Medical Center of Medical Clinic Blagomed LLC /ID# 228956
City
Kyiv
ZIP/Postal Code
01023
Country
Ukraine
Facility Name
Medical Center "OK!Clinic+" /ID# 228958
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Medical Center CONSILIUM MEDICAL /ID# 228959
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
PI "Poltava Regional Clinical Hospital n.a. M.V.Sklifosovsky" /ID# 228962
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
CNE Vinnytsya Regional Clinical Hospital named after N.I.Pirogov /ID# 228954
City
Vinnytsia
ZIP/Postal Code
21028
Country
Ukraine
Facility Name
Clinic of Scientific Research Institute of Invalid Rehabilitation /ID# 228955
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/abbvie/
Learn more about this trial
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)
We'll reach out to this number within 24 hrs