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
  • End date
    May 10, 2024
  • participants needed
    425
  • sponsor
    AbbVie
Updated on 19 September 2021
methotrexate
stiffness
rheumatism
antirheumatics

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.

Details
Condition Rheumatoid Arthritis
Treatment Placebo, ABBV-154
Clinical Study IdentifierNCT04888585
SponsorAbbVie
Last Modified on19 September 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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