EUCTR2008-000744-13-DE进行中（未招募）不适用
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
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Patients must give written informed consent by signing an IRB/EC-approved Informed Consent Form (ICF) prior to admission to this study
- •a) An ICF Addendum must be signed by any patient with a history of thrombo-embolic event(s) (e.g., deep vein thrombosis, pulmonary embolism, etc.) or abnormal activated protein C (APC) resistance test result (< LLN for the central reference laboratory) to acknowledge the increased risk of experiencing similar events because of the prior history of thrombo-embolic event(s) or abnormal APC resistance. It is unknown whether or not exposure to R788 will further increase such risk.
- •2) Patients who are being treated in Study C-788-006X
- •3) Patients who completed Studies C-788-010 or C-788-011 and did not withdraw due to adverse events
- •4) Patients who withdrew from Study C-788-010 at Month 4 or Month 5 because of a pre-defined lack of efficacy
- •5)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. See Appendix IX for the list of acceptable contraceptive methods for use during this study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)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:
- •a)unresolved Grade 2 or greater toxicity in a RA protocol studying R788.
- •b)uncontrolled or poorly controlled hypertension;
- •c)recent (within past 2 months) serious surgery or infectious disease;
- •d)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;
- •e)known to be positive for Hepatitis B, Hepatitis C or Tuberculosis;
- •f)interstitial pneumonitis or active pulmonary infection;
- •g)known laboratory abnormalities: ALT > 1.2x ULN, Alk Phos > 2x ULN, creatinine > 1.5x ULN, an ANC < 1,500/mm3 or 1.5 x 109/L, Hgb < 9 g/dL or 5 mmol/L, platelet count < 125,000/mm3 or 125 x 109/L are excluded.
- •2)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.
- •3)The patient is unable to report for clinical and laboratory monitoring as per protocol.
研究者
相似试验
进行中（未招募）
1 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 StudyRheumatoid ArthritisEUCTR2008-000744-13-BEAstraZeneca AB800
进行中（未招募）
不适用
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 - NDEUCTR2008-000744-13-ITRIGEL PHARMACEUTICALS INC800
进行中（未招募）
不适用
ong Term Follow On Safety Study of Fostamatinib in Patients Who Have Completed the Treatment Phase of a Rigel-Sponsored R935788 StudyMedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid ArthritisEUCTR2008-000744-13-BGAstraZeneca AB800
已完成
不适用
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-M069M069PER-052-09AstraZeneca AB,7
进行中（未招募）
不适用
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 StudyRheumatoid ArthritisEUCTR2008-000744-13-FRRigel Pharmaceuticals, Inc800