Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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 compromised of a 12 week double-blind, placebo-controlled period, a double-blind long term extension (LTE) of 66 weeks, and a follow-up visit 70 days after the last dose of the study drug. In the LTE period, 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.

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)

Keywords

Rheumatoid Arthritis (RA) ABBV-154 Arthritis Arthritis, Rheumatoid Dose A of ABBV-154 Dose B of ABBV-154 Dose C of ABBV-154 EOW Dose C of ABBV-154 E4W

Eligibility

You can join if…

Open to people ages 18-75

  • Clinical diagnosis of rheumatoid arthritis(RA) with fulfillment of the 2010 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 CAN'T join if...

--Participant discontinued prior adalimumab therapy due to intolerability or toxicity.

Locations

  • Univ California, San Francisco /ID# 228288 not yet accepting patients
    San Francisco California 94143-2204 United States
  • East Bay Rheumatology Medical /ID# 228099 not yet accepting patients
    San Leandro California 94578 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT04888585
Phase
Phase 2
Study Type
Interventional
Last Updated