A Study of The Effect of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate on Articular Damage in The Hand in Patients With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response to Non-Biological DMARDs
Inadequate response to stable dose of a non-biological DMARD for at least 3 months
Oral corticosteroids must have been on stable dose for at least 25 out of 28 days before first dose of study drug
Patient on outpatient treatment
You may not be if
Major surgery (including joint surgery) in the 8 weeks prior to screening, or planned major surgery within 6 months of randomization
Rheumatic autoimmune disease other than rheumatoid arthritis
American College of Rheumatology (ACR) functional class IV
History of or current inflammatory joint disease other than rheumatoid arthritis
Previous inadequate response to a biologic DMARD; prior biologic therapy for no longer than 1 month is allowed if discontinued for reasons of tolerability at least 6 months prior to study recruitment
Intra-articular or parenteral corticosteroids within 6 weeks prior to study start
Inadequate hematologic, renal or liver function
Positive for hepatitis B, hepatitis C or HIV infection
Pregnant or lactating women
History of severe allergic reactions or anaphylaxis to human, humanized or mural monoclonal antibodies
Current infections or history of recurrent infections
History of or currently active primary or acquired immunodeficiency
Active tuberculosis requiring treatment in the previous 3 years
Body weight \> 150 kg
Clareo Health | A Study of The Effect of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate on Articular Damage in The Hand in Patients With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response to Non-Biological DMARDs
