EUCTR2014-005376-29-HU进行中（未招募）1 期
An open label interventional phase 4 study to evaluate efficacy, safety and mucosal healing of early versus late use of vedolizumab in Crohn's disease: the LOVE-CD study (LOw countries VEdolizumab in CD study) - LOVE-CD
Academic Medical Center, Gastroenterology0 个研究点目标入组 260 人开始时间: 2017年8月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 260
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. In the opinion of the investigator, the subject is capable of understanding and complying with
- •protocol requirements.
- •2. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- •3. Age 18 to 80.
- •4. Male or non-pregnant, non-lactating females. Females of child bearing potential must have a negative serum pregnancy test prior to randomization, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the source records (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]).
- •5. Established diagnosis of ileal, ileocolonic or colonic Crohn’s disease with histopathological confirmation available in the record of the patient.
- •6. Moderately to severely active CD (CDAI 220-450) with objective evidence of ulcerations visualized on endoscopy.
- •7. Anti-TNF discontinued for at least 4 weeks prior to baseline.
- •GROUP 1 (EARLY CD):
- •8. Diagnosis of CD < 24 months prior to enrollment.
- •9. Demonstrated failure to respond to topical or systemic corticosteroids or intolerance to corticosteroids
- •or: need for 1 course of steroids since diagnosis
- •or: steroid dependency at any dose since diagnosis,
- •and additionally, but not mandatory, lack of efficacy or intolerance to thiopurines (azathioprine, 6-mercaptopurine or 6-thioguanine)(any duration). Patients using thiopurines must have been using the agent for > 3 months (last 4 weeks at stable dose).
- •GROUP 2 (LATE CD):
- •10. Diagnosis of CD > 24 months prior to enrollment.
- •11. Subject has been treated with corticosteroids and demonstrated failure to respond to corticosteroids and at least 3 months of thiopurines or intolerance to thiopurines
- •and: failure to respond to at least 1 anti-TNF or intolerance to anti-TNF or loss of response to at least 1 anti-TNF.
- •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 240
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Previous exposure to any anti-integrin antibodies including vedolizumab, a4ß7 antibodies, ß7 antibodies, anti-MADCAM-1.
- •2. Contraindication for endoscopy.
- •3. History of colonic dysplasia or colonic cancer.
- •4. Presence of stoma.
- •5. Subjects with a pouch.
- •6. Received other biologics within the last 4 weeks of baseline.
- •7. Use of 5-ASA or corticosteroid enemas/suppositories within 2 weeks of enrollment.
- •8. Chronic hepatitis B or C infection.
- •9. Subjects with ALT or AST 3x the upper limit of normal measured at screening.
- •10. Evidence of or treatment for C. difficile infection or other intestinal pathogen at screening within 4 weeks prior to enrollment.
- •11. Active or latent tuberculosis.
- •12. Conditions which in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedures.
- •13. Received any investigational drug in the past 30 days or 5 half-lives, whichever is longer.
- •14. Positive PML subjective symptom checklist before enrollment.
- •15. Subjects with known allergy or hyposensitivity to vedolizumab or its components.
- •16. Cancer (other than resected cutaneous basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence). Subjects with a history of cancer and a documented 2-year disease free period before screening, may enter the study.
- •17. Early CD group: previous exposure to any anti-TNF.
研究者
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