NCT00805467终止2 期
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
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 624
- 试验地点
- 1
- 主要终点
- Percentage of Patients Who Had at Least 1 Treatment Emergent Adverse Event in Any Category
研究概览
简要总结
The purpose of this new research study is to gain additional information about how safe and effective R935788 is over a longer period of time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must give written informed consent by signing an IRB/EC-approved Informed Consent Form (ICF) prior to admission to this study
- •Patients who are being treated 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 because of a pre-defined lack of efficacy
- •Females of childbearing potential must be fully informed of the potential for R788 to adversely affect the fetus and, if sexually active, must agree to use a well established method of birth control during the study (oral contraceptive, mechanical barrier, long acting hormonal agent). These patients must not be lactating and must have a negative pregnancy test at the time of entry and at each laboratory determination.
排除标准
- •The patient has a history of, or a concurrent, clinically significant illness, medical condition (other than arthritis) or laboratory abnormality that, in the Investigator's opinion, could affect the conduct of the study. Specifically, excluded are patients with the following:
- •unresolved Grade 2 or greater toxicity in a RA protocol studying R788
- •uncontrolled or poorly controlled hypertension;
- •recent (within past 2 months) serious surgery or infectious disease;
- •recent history (since enrollment in prior R788 study) of, or treatment for, a malignancy other than non-melanomatous skin cancer, or any history of lymphoma;
- •known to be positive for Hepatitis B, Hepatitis C, HIV or Tuberculosis;
- •interstitial pneumonitis or active pulmonary infection;
- •known laboratory abnormalities: ALT > 1.2 x ULN, creatinine >1.5x ULN, an ANC <2,500/mm3 or 2.5 x 109/L, lymphocyte count < 600/mm3 or 0.6 x 109L, Hgb < 9 g/dL or 5 mmol/L, platelet count <125,000/mm3 or 125 x 109/L are excluded.
- •The patient has a history of substance abuse, drug addiction or alcoholism. Patients may consume up to 4 units of alcohol per week; however, alcohol should be avoided in the 72 hours prior to lab assessments. Patients who cannot reliably comply with this should be excluded. A unit of alcohol is defined as the following: Beer = 12 oz or 355 mL; wine = 5 oz or 148 mL; sweet dessert wine = 3 oz or 89 mL; 80 proof distilled spirits = 1.5 oz or 44 mL.
- •The patient is unable to report for clinical and laboratory monitoring as per protocol.
研究组 & 干预措施
1
Experimental
R935788 50 mg tablet, orally, twice-a-day
干预措施: Fostamatinib Disodium (R935788) (Drug)
2
Experimental
R935788 100 mg tablet, orally, twice-a-day
干预措施: Fostamatinib Disodium (R935788) (Drug)
3
Experimental
R935788 100 mg tablet, orally, once-a-day
干预措施: Fostamatinib Disodium (R935788) (Drug)
4
Experimental
R935788 150 mg tablet, orally, once-a-day
干预措施: Fostamatinib Disodium (R935788) (Drug)
结局指标
主要结局
Percentage of Patients Who Had at Least 1 Treatment Emergent Adverse Event in Any Category
时间窗: Entry in extension to end of study, up to a maximum of 5 years. (Variable by subject - median duration of 3 years)
AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event
次要结局
- DAS28-CRP Score(3 years)
- HAQ-DI Score(3 years)
研究者
研究点 (1)
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