EUCTR2011-005251-13-IT进行中（未招募）1 期
A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis
AMGEN INC.0 个研究点目标入组 315 人开始时间: 2012年8月27日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 315
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
- •¦ Age 18 to 65 at screening (inclusive) ¦ Diagnosis of UC established = 3 months before baseline by clinical and endoscopic evidence and corroborated by a histopathology report ¦ Moderate to severe active UC as defined by a total Mayo score of 6 to 12 with a centrally read rectosigmoidoscopy score = 2 prior to baseline ¦ Demonstrated an inadequate response to, loss of response to, or intolerance to Immunomodulators or anti-TNF agents ¦ Subjects can be receiving the following treatments: • Azathioprine or 6 mercaptopurine if treatment initiated at least 12 weeks prior to baseline and if stable dosage for = 8 weeks prior to baseline • Methotrexate up to 25 mg/week if stable dosage for = 8 weeks prior to baseline • 5 aminosalicylates and/or oral prednisone or equivalent up to 20 mg/day, if stable dosage for = 2 weeks prior to baseline ¦ Neurological exam free of clinically significant, unexplained signs or symptoms in the opinion of the investigator at screening ¦ Subject has no known history of active tuberculosis ¦ Subject has a negative test for tuberculosis during screening ¦ Subject has provided informed consent For full list of inclusion criteria, please refer to section 4.1 of the protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 305
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Disease specific: ¦ Disease limited to the rectum (ie, within 10 cm of the anal verge) ¦ Toxic megacolon ¦ Crohn's Disease ¦ History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Koch pouch, or ileostomy for UC ¦ Stool positive for C. Difficile toxin at screening Excluded Medications: ¦ Immunosuppressive therapy with either cyclosporine A, tacrolimus, or mycophenolate mofetil, within 1 month prior to baseline ¦ Prior exposure to anti TNF agents, within 2 months, or 5 times the respective elimination half life (whichever is longer) prior to baseline ¦ Any prior exposure to vedolizumab, rituximab, efalizumab, natalizumab ¦ Use of topical (rectal) aminosalicylic acid (eg, mesalamine) or topical (rectal) steroids within 2 weeks prior to baseline ¦ Use of intravenous or intramuscolar corticosteroids within 2 weeks prior to screening and during screening Laboratory Abnormalities: ¦ Abnormal laboratory results at screening: •Liver tests: either aspartate aminotransferase (AST), alanine transaminase (ALT) or alkaline phosphatase (ALP) > 2.0 Upper Limit of Normal (ULN) OR total bilirubin (TBL) > 1.5 ULN (except for subjects with Gilbert Syndrome) • White blood cell count < 3,000 cells/mm³(< 3 x 10^9/L in SI units) •Hemoglobin < 10 g/dL General: ¦ Female subject is not willing to use two highly effective methods of birth control during treatment and for = 7 months after the last dose of investigational product (except if = 2 years postmenopausal or surgically sterile)Highly effective methods of birth control include not having intercourse or using birth control methods that work at least at 99% of the time when used correctly and include hormonal birth control methods (pills, shots, implants or patches), intrauterine device, sexual activity with a male partner who had a vasectomy, condom or occlusive cap (diaphragm or cervical/vault caps) used with spermicide ¦ Subject is pregnant or breast feeding, or might become pregnant within 7 months after the last dose of investigational product For full list of exclusion criteria, please refer to section 4.2 of the protocol
研究者
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