The purpose of this study is to compare the proposed biosimilar study drug rituximab (GP2013) against a standard approved treatment rituximab (Rituxan®) to see if the study drug is as safe and effective in patients with rheumatoid arthritis.
According to the FDA, “Biosimilars are a type of biological product that are licensed (approved) by FDA because they are highly similar to an already FDA-approved biological product, known as the biological reference product (reference product), and have been shown to have no clinically meaningful differences from the reference product.”
- The study drug (GP2013 and Rituximab) is administered by IV Injection (IV).
- At least 174 people have already taken this drug in clinical trials
- All study related medications, analysis, hospital visits and procedures are free
- be at least 18 years old
- have been diagnosed with rheumatoid arthritis for at least 6 months
- have had inadequate response or intolerance to DMARDs (disease-modifying anti-rheumatic drugs) and 1 – 3 anti-TNF (tumor necrosis factor) therapies
- have received methotrexate for at least 4 months with 25 mg/week as the maximal dose
- have significant liver disease, or congestive heart failure
- be taking a high potency of opioid analgesics (e.g. methadone, hydromorphone, morphine)
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