EUCTR2008-002783-33-GR进行中（未招募）不适用
A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of theInduction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Crohn’s Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,060
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 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 4 weeks before first dose of study drug through 6 months after 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 entire study treatment period and through 6 months after last dose of study drug, OR agree to completely abstain from heterosexual contact
- •4. Diagnosis of Crohn’s disease established at least 6 months prior to enrollment by clinical and endoscopic evidence and corroborated by a histopathology report. Cases of Crohn’s disease established at least 12 months prior to enrollment for which a histopathology report is not available will be considered.
- •5. Moderate to severe CD as determined by CDAI score of 220 to 480 within 7 days of first administration of study drug and 1 of the following:
- •a) CRP level >2.87 mg/L during the screening period OR
- •b) Ileocolonoscopy with photographic documentation of a minimum of 3 non-anastomotic ulcerations (each >0.5 cm in diameter, aphthous ulcerations not sufficient) consistent with CD within 4 months prior to screening
- •6. CD involvement of the ileum and/or colon, at a minimum
- •7. Patients with extensive colitis or pancolitis of >8 years duration or left-sided colitis of >12 years duration must have evidence of a surveillance colonoscopy within 12 months of initial screening visit.
- •8. Patients with 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.
- •9. 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,
- •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 Two failed attempts to taper corticosteroids to below a dose equivalent to prednisone 10 mg daily orally on two separate occasions OR History of intolerance of corticosteroids (including Cushing’s syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, infection)
- •Immunomodulators
- •Symptoms of persistently active disease despite 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 Symptoms of persistently active disease despite a history of at least one 8 week regimen of methotrexate (=12.5 mg/week) OR History of intolerance of at least one immunomodulator (including nausea/vomiting, abdominal pain, pancreatitis, LFT abnormalities, lymphopenia, TPMT genetic mutation, infection)
- •TNF antagonists
- •Symptoms of persistently active disease despite history of at least one 4 week induction regimen of one of the following agents:
- •Infliximab 5 mg/kg IV, 2 doses at least 2 weeks apart
- •Adalimumab one 80 mg SC dose followed by one 40 mg dose at least 2 weeks apart
- •Certolizumab pegol 400 mg SC, 2 doses at least 2 weeks apart OR
- •Recurrence of symptoms during scheduled maintenance dosing foll
排除标准
- •Gastrointestinal Exclusion Criteria
- •1. Evidence of abdominal abscess at the initial screening visit
- •2. Extensive colonic resection, subtotal or total colectomy
- •3. History of >3 small bowel resections or diagnosis of short bowel syndrome
- •4. Have received tube feeding, defined formula diets, or parenteral alimentation within 21 days prior to the administration of the first dose of study drug
- •5. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
- •6. Within 30 days prior to enrollment, have received any of the following for the treatment of underlying disease:
- •a) Non-biologic therapies (eg, cyclosporine, thalidomide) other than those permitted
- •b) A non-biologic investigational therapy
- •c)An approved non-biologic therapy in an investigational protocol
- •7. Within 90 days prior to enrollment, have received any of the following:
- •a) Infliximab, adalimumab, or certolizumab pegol
- •b)Other investigational or approved biological agent
- •8. Any prior exposure to natalizumab or rituximab
- •9. 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
- •10. Evidence of or treatment for C. difficile infection within 60 days or other intestinal pathogen within 30 days prior to enrollment
- •11. Currently require or are anticipated to require surgical intervention for CD during the study
- •12. History or evidence of adenomatous colonic polyps that have not been removed
- •13. History or evidence of colonic mucosal dysplasia
- •14. Diagnosis of ulcerative 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:
- •a) History of tuberculosis
- •b) 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).
- •c) 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 of the initial screening visit
- •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: (a) adequately-treated non-metastatic basal cell skin cancer; (b) any other type of non-melanoma ski
研究者
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