| Study: | Randomized Evaluation of Long-Term Efficacy of Rituximab in Rheumatoid Arthritis |
| Study Subtitle: | REFLEX |
| Principal Investigator: | Joan Von Feldt, MD |
| Coordinator: | Janice Prodell-Glisson, RN |
| Description: | This study will compare the safety and efficacy of the investigational drug rituximab versus placebo in patients who have had an inadequate response to anti-TNF therapies. Patients in both treatment arms will also receive methotrexate (MXT) and corticosteroids, as part of their treatment regimen. Rituximab is an antibody that targets B cells. Currently, rituximab is the only B-cell directed therapeutic under late-stage investigation for the treatment of rheumatoid arthritis (RA). |
| Inclusion Criteria: | • Must be between 18 – 80 years old • Must be diagnosed with rheumatoid arthritis for at least six months • Have failed treatment with at least one (but no more than five) disease-modifying antirheumatic drugs (DMARDs), other than Methotrexate or biologics OR • Continue to have symptoms despite treatment with or could not tolerate Enbrel ® (etanaercept), Remicade ® (infliximab), or Humaria (adalimumab) |
| Exclusion Criteria: |
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