Clareo Health | A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha Therapy
A Study of RO7123520 to Evaluate the Safety and Efficacy in Participants With Moderately To Severely Active Rheumatoid Arthritis (RA) Who Are Inadequately Responding to Anti-Tumor Necrosis Factor (TNF)-Alpha Therapy
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Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of adult-onset RA as defined by the ACR 2010 criteria, for at least 6 months before screening
Moderately to severely active RA as defined by at least 4/28 tender joints and at least 4/28 swollen joints, and a DAS28 greater than or equal to (≥) 3.2
For Part 2 only: Active synovitis and/or osteitis as determined by contrast-enhanced magnetic resonance imaging
Participants must be taking stable dose of anti-TNF-alpha therapies
Participants on stable oral glucocorticoids within 6 weeks of planned randomization
Participants taking non-steroidal anti-inflammatory drugs (NSAIDs) intermittently (up to 2-3 times weekly) for short-term relief of pain and participants on regular NSAID use (on stable dose for ≥ 4 weeks)
You may not be if
Parenteral glucocorticoids administration (intramuscular, IV) of ≥50 mg within 6 weeks or less than or equal to (≤) 50 milligrams (mg) within 4 weeks prior to planned randomization, or scheduled parenteral administrations during the study
Joint(s) injected with intra-articular glucocorticoids or hyaluronic acid within 6 weeks prior to planned randomization
Active inflammatory diseases of the joints not related to RA
Systemic autoimmune disease other than RA
Juvenile idiopathic arthritis or juvenile RA and/or RA developed before the age of 16
Active fibromyalgia that makes appropriate assessment of RA disease activity challenging in the opinion of the Investigator
RA participants functional status class IV according to the ACR 1991 criteria
Participants with severe chronic or recurrent viral, bacterial, parasitic, or fungal infections
History of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection
Any identified confirmed congenital or acquired immunodeficiency
Abnormal laboratory values and liver function test
Myocardial infarction within less than 6 months prior to participation in the study
Severe central or peripheral nervous system diseases
