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)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis (RA)

In brief

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.

Key facts

Study ID

NCT04888585

Run by

AbbVie

People needed

473

Starts

2021-06-23

Expected to finish

2023-08-04

Last updated by the study team

2024-10-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Arthritis and Rheumatism Associates /ID# 228201 — Jonesboro, Arkansas, United States
• Providence Medical Foundation /ID# 228104 — Fullerton, California, United States
• Care Access Research, Huntington Beach /ID# 228163 — Huntington Beach, California, United States
• Purushotham & Akther Kotha MD, Inc /ID# 228120 — La Mesa, California, United States
• Arthritis & Osteo Medical Ctr /ID# 228239 — La Palma, California, United States
• Pacific Arthritis Care Center - Los Angeles /ID# 229330 — Los Angeles, California, United States
• California Medical Research Associates /ID# 230131 — Northridge, California, United States
• Arthritis Care And Research Center ACRC /ID# 230099 — Poway, California, United States
• East Bay Rheumatology Medical /ID# 228099 — San Leandro, California, United States
• Millennium Clinical Trials /ID# 230618 — Thousand Oaks, California, United States
• The Lundquist Institute at Harbor-UCLA Medical Center /ID# 228241 — Torrance, California, United States
• Medvin Clinical Research /ID# 228181 — Tujunga, California, United States
• Inland Rheum & Osteo Med Grp /ID# 228204 — Upland, California, United States
• Comprehensive Rheumatology Center /ID# 230132 — Woodland Hills, California, United States
• Denver Arthritis Clinic /ID# 228172 — Denver, Colorado, United States
• New England Research Associates, LLC /ID# 230127 — Bridgeport, Connecticut, United States
• Stamford Therapeutics Consorti /ID# 229214 — Stamford, Connecticut, United States
• Delaware Arthritis /ID# 229413 — Lewes, Delaware, United States
• Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 228229 — Boca Raton, Florida, United States
• Bay Area Arthritis and Osteo /ID# 228075 — Brandon, Florida, United States
• Clinical Research of West Florida, Inc /ID# 228128 — Clearwater, Florida, United States
• International Medical Research /ID# 228069 — Daytona Beach, Florida, United States
• Omega Research Debary, LLC /ID# 228293 — DeBary, Florida, United States
• Neoclinical Research /ID# 228753 — Hialeah, Florida, United States
• Elite Clinical Studies, LLC /ID# 228227 — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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