RO45-2081 FOR PATIENTS WITH RHEUMATOID ARTHRITIS

该研究是一项开放标签的多中心研究，目的是研究在NM 14876研究中招募的类风湿关节炎患者中重复剂量Ro 45-2081的长期安全性。所有在研究过早终止时仍在NM14876的患者，以及根据研究者的评估似乎受益于20- 30mg Ro 45-2081的患者，都可以选择进入本研究。在给予书面知情同意后，他们将进行为期2周的磨合期，在此期间，只允许使用稳定剂量的非甾体抗炎药和/或皮质类固醇（每天< 10mg强的松龙或同等剂量），但不允许使用改善疾病的抗风湿药物（DMARDs），然后根据本方案接受第一剂Ro 45-2081。研究期间不应增加非甾体抗炎药和/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给药20mg或50mg的Ro 45-2081。对于有生育潜力的妇女，将在筛查时和每次注射前进行尿妊娠试验并证实为阴性。

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.