Last updated on December 2018

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Rheumatoid Arthritis
  • Age: Between 18 - 80 Years
  • Gender: Male or Female

Inclusion Criteria:

  • 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 of the dominant hand/wrist 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)

Exclusion Criteria:

  • Currently receiving concomitant treatment with sulfasalazine, or leflunomide. Note: Enrollment is allowed after an appropriate wash-out period
  • Participants currently on intravenous (IV) infliximab or an approved IV biosimilar of it
  • 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

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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