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Sponsor: Hoffmann-La Roche
Conditions: Rheumatoid Arthritis
Interventions: tocilizumab [RoActemra/Actemra]
Countries: Saudi Arabia
This open-label, single arm study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs) or anti-TNF. Patients will receive RoActemra/Actemra at a dose of 8 mg/kg (max 800 mg) intravenously every 4 weeks for a total of 6 infusions. Non-biologic DMARD therapy may be continued throughout the study. Anticipated time on study treatment is 24 weeks.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Adult patients, \>/= 18 years of age * Active moderate to severe rheumatoid arthritis of \>/= 6 months duration * \>/=1 non-biologic DMARD and/or anti-TNF therapy at stable dose for \>/=8 weeks at any time prior to study treatment * Inadequate clinical response to non-biologic DMARD or anti-TNF therapy * Oral corticosteroids must be at stable dose for at least 25 out of 28 days prior to first dose of study drug Exclusion Criteria: * Pregnant or lactating women * Major surgery (including joint surgery) within 8 weeks prior to screening or major surgery planned within 6 months of enrolment * Rheumatic autoimmune disease other than RA * Functional class IV (ACR classification) * Prior history of or current joint disease other than RA * Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline * Previous treatment with RoActemra/Actemra * Known active current or history of recurrent infection * History of or currently active primary or secondary immunodeficiency * Active tuberculosis requiring treatment within the previous 3 years * Positive for HIV
- Dammam, Saudi Arabia
- Jeddah, Saudi Arabia
- Mecca, Saudi Arabia
- Riyadh, Saudi Arabia