PER-052-09已完成未知
An Open-Label, Multicenter Extension Study to Evaluate the Safety of R935788 in Patients with Rheumatoid Arthritis Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 Study
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 7
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 70（—）
- 性别
- All
入选标准
- •Patients must provide written informed consent by signing an Informed Consent Form (FCI) approved by a CRI / CE before being admitted to this study.
- •Patients under treatment in Study C-788-006X
- •Patients who completed Studies C-788-010 or C-788-011 and did not withdraw due to adverse events
- •Patients who withdrew from Study C-788-010 at Month 4 or Month 5 due to a lack of predefined efficacy
- •Women of childbearing age should be fully informed about the potential of R788 to adversely affect the fetus and, if sexually active, should agree to use a well established contraceptive method during the study (oral contraceptives, mechanical barrier, long-acting hormonal agent) . These patients should not be breastfeeding and should have a negative pregnancy test at the time of inclusion and at each laboratory determination.
排除标准
- •The patient has a history of, or is currently suffering from, a clinically significant disease, medium condition (in addition to arthritis) or laboratory abnormality that, in the opinion of the Researcher, could affect the conduct of the study. Specifically, patients who suffer from the following are excluded: a) Grade 2 or greater toxicity in an RA protocol in which R788 was studied. b) poorly controlled or uncontrolled hypertension; c) recent serious surgery or infectious disease (in the last 2 months); d) recent history (since enrollment in the previous R788 study) of, or treatment for, a malignancy except non-melanomatous skin cancer, or any history of lymphoma; e) is known positive for Hepatitis B, Hepatitis C, HIV or Tuberculosis; f) interstitial pneumonitis or active lung infection; g) known laboratory abnormalities: .ALT> 2xLNS, Creatinine> 1.5XLNS are excluded. ANC <2,500 / mm ^ 3 or 2.5X10 ^ 9 / L lymphocyte count <600 / mm3 or 0.6 x 10 ^ 9 / L, Hb <9 g / dL or 5mmol / L, platelet count <125,000 / mm ^ 3 or 125x10 ^ 9 / L.
- •The patient has a history of substance abuse, drug addiction or alcoholism. Patients can consume up to 4 units of alcohol a week; however, alcohol consumption should be avoided during the 72 hours prior to laboratory evaluations. Patients who cannot reliably meet this requirement should be excluded. One unit of alcohol is defined as: Beer = 12 oz or 355 mL; wine = 5 oz or 148 mL; sweet table wine = 3 oz or 89 mL; Spirits distilled with 80 ° alcohol = 1.5 oz or 44 mL.
- •The patient cannot go for clinical and laboratory monitoring according to the protocol.
研究者
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