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)

• Status: Recruiting
• Trial end date: 2024-05-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie

Criteria

Inclusion Criteria:

• 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).

Exclusion Criteria:

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