RO45-2081 FOR PATIENTS WITH RHEUMATOID ARTHRITIS

本研究是一项开放标签多中心研究，旨在评估既往在研究NM 14876中招募的类风湿性关节炎患者中Ro 45-2081重复给药的长期安全性。研究提前终止时仍在NM 14876中且根据研究者评估似乎从20-30 mg Ro 45-2081中获益的所有患者将可以选择进入本研究。 在给予书面知情同意后，他们将经历2周的导入期，在此期间，在他们根据本方案接受其第一剂Ro 45-2081之前，仅允许稳定剂量的NSAID和/或皮质类固醇（每天<10 mg泼尼松龙或等效剂量），但不允许使用疾病缓解抗风湿药（DMARD）。 研究期间不应增加NSAID和/或口服皮质类固醇治疗。基线评估后，每隔4周（+4天），患者将返回中心，并根据研究者的决定接受20 mg或50 mg Ro 45-2081给药。 对于有生育能力的女性，将在筛选时和每次注射前进行尿妊娠试验并验证为阴性。

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, will have 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 befoare each injection.