An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local Environment
Status and phase
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Treatments
Details and patient eligibility
About
This open-label, multi-center study in a local environment will evaluate the safety and the effect on disease activity with regard to reduction in signs and symptoms over 6 months of treatment in patients with moderate to severe active rheumatoid arthritis who experienced an inadequate response to a non-biologic DMARD. Tocilizumab 8 mg/kg will be administered as an intravenous infusion every 4 weeks for a total of 6 infusions as monotherapy or in combination with methotrexate (MTX). The anticipated time of study treatment is 24 weeks.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Adult patients >/=18 years of age
- Moderate to severe rheumatoid arthritis defined as DAS 28>3.2
- Body weight </=150 kg
- Patient on at least 1 non-biologic DMARD on a stable dose for at least 8 weeks at any time prior to study start
- Inadequate clinical response to a stable dose of a non-biologic DMARD
Exclusion criteria
- Major surgery within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
- Rheumatic autoimmune disease other than rheumatoid arthritis (RA)
- Functional class IV as defined by the ACR classification
- History or current inflammatory joint disease other than RA
- Previous treatment with any cell depleting therapy
- Previous treatment with methotrexate
- Previous treatment with tocilizumab
- Previous treatment with any biologic drug that is used in the treatment of RA
Trial design
Primary purpose
Allocation
Interventional model
Masking
51 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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