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)
Public ClinicalTrials.gov record NCT04888585. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT04888585
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 473 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 23, 2021 (Actual)
- Primary completion
- Aug 25, 2022 (Actual)
- Completion
- Aug 4, 2023 (Actual)
- Last update posted
- Oct 8, 2024
2021 – 2023
United States locations
- U.S. sites
- 101
- U.S. states
- 32
- U.S. cities
- 92
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Elite Clinical Studies, LLC /ID# 228227 | Phoenix | Arizona | 85018 | — |
| Arthritis and Rheumatism Associates /ID# 228201 | Jonesboro | Arkansas | 72401-6251 | — |
| Providence Medical Foundation /ID# 228104 | Fullerton | California | 92835 | — |
| Care Access Research, Huntington Beach /ID# 228163 | Huntington Beach | California | 92648 | — |
| Purushotham & Akther Kotha MD, Inc /ID# 228120 | La Mesa | California | 91942 | — |
| Arthritis & Osteo Medical Ctr /ID# 228239 | La Palma | California | 90623-1728 | — |
| Pacific Arthritis Care Center - Los Angeles /ID# 229330 | Los Angeles | California | 90045-6200 | — |
| California Medical Research Associates /ID# 230131 | Northridge | California | 91324 | — |
| Arthritis Care And Research Center ACRC /ID# 230099 | Poway | California | 92064 | — |
| East Bay Rheumatology Medical /ID# 228099 | San Leandro | California | 94578 | — |
| Millennium Clinical Trials /ID# 230618 | Thousand Oaks | California | 91360-3951 | — |
| The Lundquist Institute at Harbor-UCLA Medical Center /ID# 228241 | Torrance | California | 90502 | — |
| Medvin Clinical Research /ID# 228181 | Tujunga | California | 91042-2706 | — |
| Inland Rheum & Osteo Med Grp /ID# 228204 | Upland | California | 91786 | — |
| Comprehensive Rheumatology Center /ID# 230132 | Woodland Hills | California | 91364 | — |
| Denver Arthritis Clinic /ID# 228172 | Denver | Colorado | 80230 | — |
| New England Research Associates, LLC /ID# 230127 | Bridgeport | Connecticut | 06606-1827 | — |
| Stamford Therapeutics Consorti /ID# 229214 | Stamford | Connecticut | 06905 | — |
| Delaware Arthritis /ID# 229413 | Lewes | Delaware | 19958 | — |
| Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 228229 | Boca Raton | Florida | 33486 | — |
| Bay Area Arthritis and Osteo /ID# 228075 | Brandon | Florida | 33511 | — |
| Clinical Research of West Florida, Inc /ID# 228128 | Clearwater | Florida | 33765 | — |
| International Medical Research /ID# 228069 | Daytona Beach | Florida | 32117 | — |
| Omega Research Debary, LLC /ID# 228293 | DeBary | Florida | 32713-2260 | — |
| Neoclinical Research /ID# 228753 | Hialeah | Florida | 33016-1897 | — |
| University of Florida /ID# 228242 | Jacksonville | Florida | 32209 | — |
| Lakes Research, LLC /ID# 228665 | Miami | Florida | 33014 | — |
| University of Miami /ID# 228737 | Miami | Florida | 33136 | — |
| Suncoast Clinical Research /ID# 228237 | New Port Richey | Florida | 34652 | — |
| Omega Research Group /ID# 229966 | Orlando | Florida | 32808 | — |
| HMD Research LLC /ID# 228185 | Orlando | Florida | 32819 | — |
| Millennium Research /ID# 228183 | Ormond Beach | Florida | 32174 | — |
| Arthritis Center, Inc. /ID# 228209 | Palm Harbor | Florida | 34684 | — |
| BayCare Medical Group /ID# 228289 | St. Petersburg | Florida | 33705 | — |
| West Broward Rheumatology Associates /ID# 228603 | Tamarac | Florida | 33321 | — |
| Clinical Research of West Florida - Tampa /ID# 228186 | Tampa | Florida | 33606-1246 | — |
| Conquest Research /ID# 230560 | Winter Park | Florida | 32789 | — |
| Florida Medical Clinic /ID# 228236 | Zephyrhills | Florida | 33542 | — |
| Arthritis and Rheumatology /ID# 228743 | Atlanta | Georgia | 30342 | — |
| Jefrey D. Lieberman, MD, P.C. /ID# 230129 | Decatur | Georgia | 30033 | — |
| Arthritis Center of North GA /ID# 228769 | Gainesville | Georgia | 30501 | — |
| Atlanta Research Center for Rheumatology /ID# 230430 | Marietta | Georgia | 20060 | — |
| Great Lakes Clinical Trials /ID# 228699 | Chicago | Illinois | 60640 | — |
| Greater Chicago Specialty Physicians /ID# 228282 | Schaumburg | Illinois | 60195-3106 | — |
| Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 228174 | Skokie | Illinois | 60076 | — |
| Springfield Clinic /ID# 228124 | Springfield | Illinois | 62702-3749 | — |
| Beacon Medical Group Clinical Research /ID# 229153 | Granger | Indiana | 46530 | — |
| University of Iowa Hospitals and Clinics /ID# 229217 | Iowa City | Iowa | 52242 | — |
| Four Rivers Clinical Research /ID# 230109 | Paducah | Kentucky | 42001 | — |
| The Arthritis & Diabetes Clinic, Inc. /ID# 228221 | Monroe | Louisiana | 71203 | — |
| Klein and Associates MD /ID# 230145 | Cumberland | Maryland | 21502 | — |
| Klein and Associates MD - Hagerstown /ID# 230143 | Hagerstown | Maryland | 21742 | — |
| The Center for Rheumatology and Bone Research /ID# 228617 | Wheaton | Maryland | 20902 | — |
| AA Medical Research Center - Grand Blanc /ID# 228604 | Grand Blanc | Michigan | 48439 | — |
| Advanced Rheumatology, PC /ID# 228684 | Lansing | Michigan | 48910 | — |
| June DO, PC /ID# 229838 | Lansing | Michigan | 48911 | — |
| Arthritis Associates /ID# 230188 | Hattiesburg | Mississippi | 39402 | — |
| Rheumatology Consultants - Clinical Research /ID# 229208 | Tupelo | Mississippi | 38801-4949 | — |
| Clayton Medical Associates, P.C. dba Saint Louis Rheumatology /ID# 228283 | St Louis | Missouri | 63119-3845 | — |
| West County Rheumatology /ID# 228102 | St Louis | Missouri | 63131-1703 | — |
| Logan Health Research /ID# 228273 | Kalispell | Montana | 59901 | — |
| Advanced Biomedical Research of America /ID# 228596 | Las Vegas | Nevada | 89123 | — |
| Innovative Health Research /ID# 229209 | Las Vegas | Nevada | 89128 | — |
| Arthritis and Osteoporosis Associates /ID# 229418 | Freehold | New Jersey | 07728-8307 | — |
| Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 228602 | Voorhees Township | New Jersey | 08043 | — |
| Albuquerque Center For Rheumatology /ID# 228709 | Albuquerque | New Mexico | 87102 | — |
| Albuquerque Clinical Trials, Inc /ID# 228925 | Albuquerque | New Mexico | 87102 | — |
| Arthritis and Osteo Assoc /ID# 228662 | Las Cruces | New Mexico | 88011 | — |
| Buffalo Rheumatology and Medicine - Orchard Park /ID# 228710 | Orchard Park | New York | 14127 | — |
| St. Lawrence Health System /ID# 229508 | Potsdam | New York | 13676 | — |
| DJL Clinical Research, PLLC /ID# 230133 | Charlotte | North Carolina | 28211 | — |
| Cape Fear Arthritis Care /ID# 228747 | Leland | North Carolina | 28451 | — |
| PMG Research of Salisbury /ID# 230627 | Salisbury | North Carolina | 28144 | — |
| Trinity Health Med Arts Clinic /ID# 228202 | Minot | North Dakota | 58701 | — |
| University of Cincinnati /ID# 229212 | Cincinnati | Ohio | 45267-0585 | — |
| Paramount Medical Research Con /ID# 228254 | Middleburg Heights | Ohio | 44130 | — |
| Arthritis Assoc of NW Ohio /ID# 228936 | Toledo | Ohio | 43606 | — |
| Arthritis and Rheumatology Center of Oklahoma /ID# 228975 | Oklahoma City | Oklahoma | 73102 | — |
| Rheumatology Associates of Oklahoma /ID# 228701 | Oklahoma City | Oklahoma | 73116-7226 | — |
| Advanced Rheumatology & Arthritis Wellness Center /ID# 228608 | Cranberry Township | Pennsylvania | 16066 | — |
| Altoona Ctr Clinical Res /ID# 230058 | Duncansville | Pennsylvania | 16635 | — |
| Arthritis Group /ID# 229777 | Philadelphia | Pennsylvania | 19152 | — |
| PA Regional Center for Arthritis and Osteoporosis Research /ID# 228742 | Wyomissing | Pennsylvania | 19610 | — |
| Columbia Arthritis Center /ID# 228705 | Columbia | South Carolina | 29204 | — |
| West Tennessee Research Institute /ID# 228257 | Jackson | Tennessee | 38305 | — |
| Arthritis and Rheumatology Research Institute, PLLC /ID# 228937 | Allen | Texas | 75013-6147 | — |
| Allen Arthritis /ID# 228712 | Allen | Texas | 75013 | — |
| Trinity Universal Research Associates - Carrollton /ID# 230104 | Carrollton | Texas | 75007 | — |
| Adriana Pop-Moody MD Clinic PA /ID# 230062 | Corpus Christi | Texas | 78404 | — |
| West Texas Clinical Research /ID# 228276 | Lubbock | Texas | 79424 | — |
| P&I Clinical Research /ID# 230183 | Lufkin | Texas | 75904-3132 | — |
| SW Rheumatology Res. LLC /ID# 228088 | Mesquite | Texas | 75150 | — |
| Trinity Universal Research Associates, Inc /ID# 228238 | Plano | Texas | 75024-5283 | — |
| Epic Medical Research /ID# 228097 | Red Oak | Texas | 75154-3981 | — |
| Sun Research Institute /ID# 228768 | San Antonio | Texas | 78215 | — |
| Advanced Rheumatology of Houston /ID# 228170 | The Woodlands | Texas | 77382 | — |
| DM Clinical Research - Tomball /ID# 228112 | Tomball | Texas | 77375 | — |
| Rheumatology Clinic of Houston /ID# 228178 | Tomball | Texas | 77377 | — |
| Arthritis & Osteoporosis Clinic /ID# 228736 | Waco | Texas | 76710 | — |
| Tidewater Physicians Medical Center /ID# 230130 | Newport News | Virginia | 23606-4434 | — |
| Arthritis Northwest, PLLC /ID# 228275 | Spokane | Washington | 99204-2302 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 119 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04888585, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 8, 2024 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04888585 live on ClinicalTrials.gov.