Clareo Health | A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Severe Active Rheumatoid Arthritis, Comparing Tapering Versus Maintaining the Methotrexate Dosage
A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Severe Active Rheumatoid Arthritis, Comparing Tapering Versus Maintaining the Methotrexate Dosage
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Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult patients, \>/= 18 years of age
Active severe rheumatoid arthritis (DAS28 \> 5.1) according to European League of Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria
Inadequate response to a trial of 2 DMARDs, including methotrexate, a trial being defined as 6 months with 2 months at standard dose; no previous treatment with a biologic agent such as a tumor necrosis factor (TNF) inhibitor
Oral corticosteroids must have been at a stable dose of \</= 10 mg/day prednisolone or equivalent for at least 25 out of 28 days prior to start of treatment (Day 1)
You may not be if
Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
Rheumatic autoimmune disease other than rheumatoid arthritis
Functional class IV as defined by the ACR Classification of Functional Status in RA
Prior history of or current inflammatory joint disease other than RA
Previous treatment with tocilizumab
Previous treatment with any biologic drug (e.g. TNF inhibitor) that is used in the treatment of RA
Intraarticular or parenteral corticosteroids within 6 weeks prior to enrollment
Inadequate liver, bone marrow or hepatic function
Positive for hepatitis B, hepatitis C or HIV infection
Pregnant or breastfeeding women
Females of child-bearing potential who are not using reliable means of contraception
History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
Active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
History of, or currently active, primary or secondary immunodeficiency
