EUCTR2013-004282-14-PT进行中（未招募）1 期
PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OFETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 397
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
- •- 18-80 years of age, inclusive.
- •- Diagnosis of UC established at least 3 months prior to Day 1 by clinical and endoscopic evidence
- •- Moderately to severely active UC as determined by the Mayo Clinic Score assessment (MCS)
- •- Evidence of UC extending a minimum of 20 cm from the anal verge as determined by baseline endoscopy
- •- Naive to treatment with any anti-TNF inhibitor therapy
- •- An inadequate response to, loss of response to, or intolerance to prior corticosteroid and/or immunosuppressant treatment
- •- Background regimen for UC may include oral 5-aminosalicylic acid (5-ASA), oral corticosteroids, budenoside, probiotics, azathioprine (AZA), 6-
- •mercaptopurine(6-MP), or methotrexate (MTX) if doses are stable, as defined by the protocol
- •- Use of highly effective contraception as defined by the protocol
- •- Received a colonoscopy within the past year or be willing to undergo a
- •colonoscopy in lieu of a flexible sigmoidoscopy at screening
- •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 370
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •-Prior extensive colonic resection, subtotal or total colectomy, or planned surgery for UC
- •- A history of or current conditions and diseases affecting the digestive tract, such as ileostomy or colostomy indeterminate colitis, suspicion of
- •ischemic colitis, radiation colitis, or microscopic colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal
- •obstruction, toxic megacolon, or unremoved adenomatous colonic polyps
- •- Have received non-permitted inflammatory bowel disease (IBD)
- •therapies (including etrolizumab or other anti-integrin agents such as
- •natalizumab, vedolizumab, and efalizumab), as stated in the protocol
- •- Any prior treatment with anti-adhesion molecules (e.g., anti-MAdCAM-1)
- •- Any prior treatment with rituximab
- •- Any treatment with tofacitinib during screening
- •- History of moderate or severe allergic or anaphylactic/anaphylactoid reactions to chimeric, human, or humanized antibodies, fusion proteins,
- •or murine proteins or hypersensitivity to etrolizumab or any of the excipients
- •- Neurologic conditions or diseases that may interfere with monitoring for PML
- •- History of demyelinating disease
- •- Clinically significant abnormalities on screening neurologic examination (PML Objective/Subjective Checklists)
- •- History of cancer, including hematologic malignancy, solid tumors, and carcinoma in situ, within 5 years before screening, as defined by the protocol
- •- Congenital or acquired immune deficiency, chronic hepatitis B or C infection, HIV positive or history of tuberculosis (active or latent)
- •- Evidence of or treatment for Clostridium difficile (as assessed by C. difficile toxin testing) within 60 days prior to Day 1 or other intestinal
- •pathogens within 30 days prior to Day 1.
- •- Evidence of or treatment for clinically significant cytomegalovirus (CMV) colitis within 60 days prior to Day 1.
- •- History of recurrent opportunistic infections and/or history of severe disseminated viral infections, or organ transplant
- •- Any serious opportunistic infection within the last 6 months
- •- Any major episode of infection requiring treatment with IV antibiotics within 8 weeks prior to screening or oral antibiotics within 4 weeks prior
- •to screening
- •- Received a live attenuated vaccine within 4 weeks prior to Day 1
研究者
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