A Study of LY3462817 in Participants With Rheumatoid Arthritis

  • STATUS
    Recruiting
  • End date
    Jul 15, 2022
  • participants needed
    80
  • sponsor
    Eli Lilly and Company
Updated on 22 September 2021
DMARD
rheumatism
biologic disease-modifying antirheumatic drug
rheumatoid factor
antirheumatics

Summary

The reason for this study is to see if the study drug LY3462817 is safe and effective in participants with moderately to severely active rheumatoid arthritis (RA).

Details
Condition Rheumatoid Arthritis, Rheumatoid Arthritis (Pediatric)
Treatment Placebo, LY3462817
Clinical Study IdentifierNCT04634253
SponsorEli Lilly and Company
Last Modified on22 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Have a diagnosis of adult onset RA as defined by the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for at least 3 months prior to screening
Have moderately to severely active RA defined by the presence of 6 swollen joints (based on 66 joint count) and 6 tender joints (based on 68 joint count) at screening and baseline. The distal interphalangeal joint should be evaluated but not included in the total count to determine eligibility
Have at least 1 of the following
positive test results for rheumatoid factor or anti-citrullinated peptide antibodies at screening, OR
previous radiographs documenting bony erosions in hands or feet consistent with RA
Have C-reactive protein (CRP) >1.2 times upper limit of normal (ULN) per the central laboratory at screening
Demonstrated an inadequate response to, or loss of response or intolerance to
at least 1 conventional synthetic disease-modifying antirheumatic drug (csDMARD) treatment OR
at least 1 biologic DMARD/tsDMARD treatment

Exclusion Criteria

Class IV RA according to ACR revised response criteria
Have a diagnosis or history of malignant disease within 5 years prior to baseline, with the exceptions of
basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years, or
cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to baseline
Have presence of confirmed cervical dysplasia
Have had various types of infection within 3 months of screening or develops any of these infections before the randomization visit
Have any of the following
Human immunodeficiency virus (HIV) infection
Current infection with hepatitis B virus (HBV) (i.e., positive for hepatitis B surface antigen and/or polymerase chain reaction (PCR) positive for HBV DNA
Current infection with hepatitis C virus (HCV) (i.e., positive for HCV RNA)
Active tuberculosis (TB)
Have failed more than 2 biologic DMARDs (bDMARDs) or tsDMARDs (e.g. excluded if have received 2 bDMARDs and 1 tsDMARD)
Clear my responses

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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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