Clareo Health | A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis
A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
With
Hoffmann-La Roche
Age
18–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult patients 18-80 years of age.
Rheumatoid arthritis (RA) for ≥ 6 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis.
Receiving outpatient treatment for RA.
Swollen joint count (SJC) ≥ 8 (66 joint count), and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.
At screening, either
* C-reactive protein (CRP) ≥ 0.6 mg/dL (6 mg/L), or
Inadequate response to methotrexate, having received and tolerated at a dose of 10-25 mg/week it for ≥ 12 weeks.
You may not be if
Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA.
Inflammatory joint disease other than RA, or other systemic autoimmune disorder.
Diagnosis of juvenile rheumatoid arthritis, or RA before the age of 16.
Surgery within 12 weeks of study or planned within 24 weeks of randomization.
Previous treatment with any approved or investigational biological agent for RA, an anti-alpha4-integrin antibody or co-stimulation modulator, or cell-depleting therapy.
