EUCTR2008-002782-32-CZ进行中（未招募）不适用
A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients with Moderate to Severe Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 826
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. Age 18 to 80
- •2. Male or female patient who is voluntarily able to give informed consent
- •3. Female patients must:
- •be post-menopausal for at least 1 year before the screening visit, OR
- •be surgically sterile, OR
- •(if they are of childbearing potential) agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 6 months after the last dose of study drug, OR
- •agree to completely abstain from heterosexual contact.
- •Male patients, even if surgically sterilized (ie, status post-vasectomy), must:
- •agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, OR
- •agree to completely abstain from heterosexual contact.
- •4. Diagnosis of ulcerative colitis established at least 6 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report.
- •5. Moderate to severe ulcerative colitis as determined by a Mayo score of 6 to 12 with an endoscopic subscore =2 during the screening period
- •6. Evidence of ulcerative colitis extending proximal to the rectum (=15 cm of involved colon)
- •7. Patients with extensive colitis or pancolitis of >8 years duration or left-sided colitis of >12 years duration must have documented evidence of a surveillance colonoscopy within 12 months of the initial screening visit (may be performed during screening).
- •8. Patients with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age >50 years, or other known risk factor must be up-to-date on colorectal cancer surveillance (may be performed during screening)
- •9. Demonstrated, over the previous 5 year period, an inadequate response to, loss of reponse to, or intolerance of at least one of the following agents as defined below:
- •Corticosteroids
- •i) Signs and symptoms of persistently active disease despite a history of at least one 4-week induction regimen that included a dose equivalent to prednisone 30 mg daily orally for 2 weeks or intravenously for 1 week OR
- •ii) Recurrence of clinical symptoms upon tapering below a dose equivalent to prednisone 10 mg daily orally on two separate occasions OR
- •iii) History of intolerance of corticosteroids (including, but not limited to Cushing’s syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, infection)
- •Immunomodulators
- •i) Signs and symptoms of persistently active disease despite a history of at least one 8 week regimen of oral azathioprine (=1.5 mg/kg) or 6-mercaptopurine mg/kg (=0.75 mg/kg) OR
- •ii) History of intolerance of at least one immunomodulator (including, but not limited to nausea/vomiting, abdominal pain, pancreatitis, LFT abnormalities, lymphopenia, TPMT genetic mutation, infection)
- •TNF antagonists
- •i) Signs and symptoms of persistently active disease despite a history of at
- •least one 4 week induction regimen of infliximab 5 mg/kg IV, 2 doses at
- •least 2 weeks apart OR
- •ii) Recurrence of symptoms during maintenance dosing following prior
- •clinical benefit (discontinuation despite clinical benefit does not qualify)
- •iii) History of intolerance of infliximab (including, but not limited to infusionrelated
- •reaction, demyelination, congestive heart failure, infection)
- •10. May be receiving a therapeutic dose of the following drugs:
- •Oral 5-ASA compounds provided that the dose has been stable for the 2 weeks immediately prior to enrollment
- •Oral corticosteroid therapy
排除标准
- •The exclusion criteria are divided into 3 categories: gastrointestinal exclusion criteria, infectious disease exclusion criteria, and general exclusion criteria. Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
- •Gastrointestinal Exclusion Criteria
- •1. Evidence of abdominal abscess or toxic megacolon at the initial screening visit
- •2. Extensive colonic resection, subtotal or total colectomy
- •3. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
- •4. Within 30 days prior to enrollment, have received any of the following for the treatment of underlying disease:
- •Non-biologic therapies (eg, cyclosporine, thalidomide) other than those
- •permitted in Section 6.2
- •A non-biologic investigational therapy
- •An approved non-biologic therapy in an investigational protocol
- •5. Within 60 days prior to enrollment, have received any of the following:
- •Infliximab
- •Other investigational or approved biological agent
- •6. Any prior exposure to natalizumab, efalizumab or rituximab
- •7. Use of topical (rectal) treatment with 5-ASA or corticosteroid enemas/suppositories within 2 weeks of the administration of the first dose of study drug
- •8. Evidence of or treatment for C. difficile infection within 60 days or other intestinal pathogen within 30 days prior to enrollment
- •9. Currently require or are anticipated to require surgical intervention for UC during the study
- •10. History or evidence of adenomatous colonic polyps that have not been removed
- •11. History or evidence of colonic mucosal dysplasia
- •12. Diagnosis of Crohn’s colitis or indeterminate colitis
- •Infectious Disease Exclusion Criteria
- •1. Any chronic hepatitis B or C infection
- •2. Active or latent tuberculosis, regardless of treatment history, as evidenced by any of the following:
- •History of tuberculosis
- •A positive diagnostic tuberculosis (TB) test within one month of enrollment defined as:
- •i) a positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests OR
- •ii) a tuberculin skin test reaction =10 mm ( =5 mm in patients receiving the equivalent of > 15 mg/day prednisone).
- •Chest x-ray within 3 months of enrollment in which active or latent pulmonary tuberculosis cannot be excluded
- •3. Any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation)
- •4. Any live vaccinations within 30 days prior to study drug administration except for the influenza vaccine
- •5. Clinically significant extra-intestinal infection (eg, pneumonia, pyelonephritis) within 30 days prior to enrollment
- •General Exclusion Criteria
- •1. Previous exposure to MLN0002
- •2. Female patients who are lactating or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 prior to study drug administration.
- •3. Any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, would confound the study results or compromise patient safety
- •4. Had any surgical procedure requiring general anesthesia within 30 days prior to enrollment or is planning to undergo surgery during the study period
- •5. Any history of malignancy, except for the following:
- •adequately-treated non-metastatic basal cell skin cancer;
- •Squamous cell skin cancer that
研究者
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