PROTOCOL NI15171--RO45-2081 FOR PATIENTS PREVIOUSLY ENROLLED IN STUDY NMI4876

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The study is an open-label-multi-center investigation of the long-term safety of repeated doses of Ro 45-2081 in patients with rheumatoid arthritis previously recruited in study NM 14876. All patients who were still in NM14876 when the study was prematurely discontinued and who seemed to benefit from 20-30 mg of Ro 45-2081 according to the investigator's assessment, willhave the option to enter this study. After having given written informed consent, they will undergo a 2 week run-in period during which only stable doses of NSAIDs and/or corticosteroids (<10 mg of prednisolone or equivalent dose per day) but no disease-modifying antirheumatic drug (DMARDs) are allowed before they receive their first dose of Ro 45-2081 under this protocol. NSAIDs and/or oral corticosteroid treatment should not be increased during the study. After baseline assessments, at intervals of 4 weeks (+4days), the patients will return to the center and will be dosed with 20 mg or 50 mg of Ro 45-2081 according to the investigator's decision. For women of childbearing potential, a urinary pregnancy test will be done and verified as negative, at screening and before each injection.