A Randomized Double-Blind Parallel-Group Placebo-Controlled Multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Inadequately Controlled by Tumor Necrosis Factor Alpha (TNF-a) Inhibitor 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 - 150 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects have the ability to understand and sign a written informed consent form
    2. Subjects must be at least 18 years old
    3. Subjects must diagnosis of adult-onset RA classified by ACR/EULAR 2010 revised classification criteria for RA
    4. Subject must have been treated with oral, SC, or intramuscular (IM) MTX for at least 12 weeks prior to Screening at a dose of 15 to 25 mg/week
    5. Subjects should be willing to take folic acid or equivalent throughout the study
    6. Subjects must have moderately to severely active RA disease
    7. Subjects must have a documented inadequate response to treatment with =1 licensed TNFi following at least 12 weeks of therapy with that agent.

You may not be eligible for this study if the following are true:

    1. Subjects who have diagnosis of any other inflammatory arthritis or systemic rheumatic disease
    2. Subjects who are Steinbrocker class IV functional capacity
    3. Subjects who have prior exposure to any licensed or investigational compound directly or indirectly targeting IL-6 or IL-6R
    4. Subjects with prior treatment with cell-depleting therapies, including anti-CD20 agents or investigational agents
    5. Subjects who have prior use of bDMARDs within the following windows prior to baseline
    6. Subjects who have use of parenteral and/or intra-articular glucocorticoids within 4 weeks prior to baseline
    7. Subjects who have use of oral glucocorticoids greater than 10 mg/day prednisone (or equivalent) or change in dosage within 2 weeks prior to baseline
    8. Subjects with prior documented history of no response to hydroxychloroquine and sulfasalazine
    9. Subjects with prior use of cDMARDs
    10. Subjects with vaccination with live vaccines in the 6 weeks prior to baseline or planned vaccination with live vaccines during the study
    11. Subjects participating in any other investigational drug study within 30 days or 5 times the terminal half-life of the investigational drug, whichever is longer, prior to baseline
    12. Subjects who have other treatments for RA
    13. Subjects with use of intra-articular hyaluronic acid injections within 4 weeks prior to baseline
    14. Subjects with use of non-steroidal anti-inflammatory drugs (NSAIDs) on unstable dose or switching of NSAIDs within 2 weeks prior to baseline
    15. Subjects who have previous participation in this study (randomized) or another study of OKZ
    16. Subjects who have abnormal laboratory values as per protocol
    17. Subjects with concurrent acute or chronic viral hepatitis B or C infection as detected by blood tests at Screening
    18. Subjects with HIV infection
    19. Subjects with suspected or confirmed current active TB disease or history of active TB
    20. Subjects with concurrent malignancy or a history of malignancy within the last 5 years
    21. Subjects with uncompensated congestive heart failure or untreated arterial hypertension, or uncontrolled CV disorder
    22. Subjects with severe or uncontrolled medical condition that would effect participation in the study
    23. Subjects with uncontrolled diabetes mellitus
    24. Subjects with any infection requiring oral antibiotic or antiviral therapy
    25. Subjects with evidence of disseminated herpes zoster infection, zoster encephalitis, meningitis, or other non-self-limited herpes zoster infections in the 6 months prior to baseline
    26. Subjects with planned surgery during the study or surgery =4 weeks prior to Screening and from which the subject has not fully recovered
    27. Subjects with diverticulitis or other symptomatic GI conditions
    28. Pre-existing central nervous system demyelinating disorders
    29. History of chronic alcohol or drug abuse
    30. Female subjects who are pregnant or lactating
    31. Subjects with a known hypersensitivity to any component of the OKZ drug product or placebo
    32. Subjects with a known hypersensitivity or contraindication to any component of the rescue medication
    33. Subjects with history of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
    34. Subject's unwillingness or inability to follow the procedures outlined in the protocol
    35. Subjects with other medical or psychiatric conditions or laboratory abnormalities that may increase potential risk associated with study participation and administration of investigational products

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