A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate (MTX) in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One Tumor Necrosis Factor (TNF)-Inhibitor
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Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult patients, \>/= 18 years of age
Rheumatoid arthritis of \>/= 6 months duration (according to American College of Rheumatology (ACR) criteria)(according to ACR criteria)
Inadequate response due to inefficacy of treatment (for at least 3 months) with only one approved Tumor Necrosis Factor (TNF)-agent other than adalimumab Depending on the TNF-inhibitor, last dose of TNF-inhibitor should have been 1 to 8 weeks before randomization to the study
On methotrexate treatment for \>/=12 weeks immediately prior to baseline, with stable dose (10-25 mg/week) for the last 8 weeks
Disease Activity Score (DAS28) \>3.2 at baseline
Oral corticosteroids (\</=10 mg/day prednisone or equivalent) and non-steroidal anti-inflammatory drugs (NSAIDs) are permitted if the dose has been stable for \>/=6 weeks prior to baseline.
You may not be if
Major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 6 months following randomization
Rheumatic autoimmune disease other than rheumatoid arthritis
Prior history of or current inflammatory joint disease other than rheumatoid arthritis
Functional class IV (ACR criteria)
History of severe allergic reaction to human, humanized or murine monoclonal antibodies
Known active current or history of recurrent infection (including tuberculosis)
Primary or secondary immunodeficiency (history of or currently active)
Body weight \>150 kg
Previous treatment with any cell-depleting therapies
Previous treatment with tocilizumab
Intra-articular or parenteral corticosteroids within 6 weeks prior to baseline.
Clareo Health | A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate (MTX) in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One Tumor Necrosis Factor (TNF)-Inhibitor
