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:
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Conditions: Rheumatoid Arthritis
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Age: Between 18 years - 150 years
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Gender: Male or Female
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Other Inclusion Criteria:
- Subjects have the ability to understand and sign a written informed consent form
- Subjects must be at least 18 years old
- Subjects must diagnosis of adult-onset RA classified by ACR/EULAR 2010 revised classification criteria for RA
- 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
- Subjects should be willing to take folic acid or equivalent throughout the study
- Subjects must have moderately to severely active RA disease
- 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:
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- Subjects who have diagnosis of any other inflammatory arthritis or systemic rheumatic disease
- Subjects who are Steinbrocker class IV functional capacity
- Subjects who have prior exposure to any licensed or investigational compound directly or indirectly targeting IL-6 or IL-6R
- Subjects with prior treatment with cell-depleting therapies, including anti-CD20 agents or investigational agents
- Subjects who have prior use of bDMARDs within the following windows prior to baseline
- Subjects who have use of parenteral and/or intra-articular glucocorticoids within 4 weeks prior to baseline
- 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
- Subjects with prior documented history of no response to hydroxychloroquine and sulfasalazine
- Subjects with prior use of cDMARDs
- Subjects with vaccination with live vaccines in the 6 weeks prior to baseline or planned vaccination with live vaccines during the study
- 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
- Subjects who have other treatments for RA
- Subjects with use of intra-articular hyaluronic acid injections within 4 weeks prior to baseline
- Subjects with use of non-steroidal anti-inflammatory drugs (NSAIDs) on unstable dose or switching of NSAIDs within 2 weeks prior to baseline
- Subjects who have previous participation in this study (randomized) or another study of OKZ
- Subjects who have abnormal laboratory values as per protocol
- Subjects with concurrent acute or chronic viral hepatitis B or C infection as detected by blood tests at Screening
- Subjects with HIV infection
- Subjects with suspected or confirmed current active TB disease or history of active TB
- Subjects with concurrent malignancy or a history of malignancy within the last 5 years
- Subjects with uncompensated congestive heart failure or untreated arterial hypertension, or uncontrolled CV disorder
- Subjects with severe or uncontrolled medical condition that would effect participation in the study
- Subjects with uncontrolled diabetes mellitus
- Subjects with any infection requiring oral antibiotic or antiviral therapy
- 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
- Subjects with planned surgery during the study or surgery =4 weeks prior to Screening and from which the subject has not fully recovered
- Subjects with diverticulitis or other symptomatic GI conditions
- Pre-existing central nervous system demyelinating disorders
- History of chronic alcohol or drug abuse
- Female subjects who are pregnant or lactating
- Subjects with a known hypersensitivity to any component of the OKZ drug product or placebo
- Subjects with a known hypersensitivity or contraindication to any component of the rescue medication
- Subjects with history of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
- Subject's unwillingness or inability to follow the procedures outlined in the protocol
- Subjects with other medical or psychiatric conditions or laboratory abnormalities that may increase potential risk associated with study participation and administration of investigational products
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.