JPRN-jRCTs011200009招募中4 期
A study to evaluate the relationship between the pharmacokinetics of vedolizumab in the colon tissue and in the serum concentrations, alpha4beta7 integrin receptor occupancy and the efficacy in subjects with moderately to severely active ulcerative colitis and treated by vedolizumab IV - vedolizumab-4026
Fujiya Mikihiro0 个研究点目标入组 30 人开始时间: 2020年11月6日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •1. Subject who is capable of understanding and complying with protocol requirements in the opinion of the investigator.
- •2. Subject who signs and dates a written informed consent form prior to the initiation of any study procedures.
- •3. Subjects who have had a diagnosis of moderate to severe UC for at least 3 months prior to enrollment.
- •4. Subjects with complete Mayo score of 6 to 12 and endoscopic subscore of>=2 within 10 days before the initial administration of vedolizumab.
- •5. Subjects who met the following treatment failure criteria with at least one of the following agents:
- •Corticosteroids
- •Resistance subjects whose response was inadequate after treatment of>=40 mg day for>=1 week (oral or intravenous IV) or 30 to 40 mg day for>=2 weeks (oral or IV) or topical therapy for >=2 weeks in case of distal UC.
- •Dependence subjects for which it was difficult to reduce the dosage to <10 mg day due to recurrence during gradual dose reduction (oral or IV) or for which it was difficult to discontinue topical therapy.
- •Intolerance subjects who were unable to receive continuous treatment due to adverse reactions (e.g. Cushings syndrome osteopenia osteoporosis hyperglycemia insomnia infection).
- •Immunomodulators (azathioprine AZA or 6 mercaptopurine 6 MP)
- •Refractory subjects whose response was inadequate after treatment for>=12 weeks.
- •Intolerance subjects who were unable to receive continuous treatment due to adverse reactions(e.g. nausea vomiting abdominal pain pancreatitis liver function test abnormalities lymphopenia thiopurine S methyltransferase genetic mutation infection).
- •TNFalpha antagonist
- •Inadequate response subjects whose response was inadequate after the induction therapy in the dosage described in the package insert.
- •Loss of response subjects who had recurrence during the scheduled maintenance therapy after achievement of clinical response (those who withdrew for other reasons than relapse is not applicable here).
- •Intolerance subjects who were unable to receive continuous treatment due to adverse reactions (e.g. infusion related reaction demyelination congestive heart failure infection).
- •6. Subject aged 20 to 80 years at informed consent.
排除标准
- •1. Subjects who had extensive colonic resection subtotal or total colectomy
- •2. Subjects who are classified as proctitis UC (inflammation is limited to the rectum)
- •3. Subjects who had ileostomy, colostomy or symptomatic intestinal stricture
- •4. Subjects who had received any of the following biologic within the designated period before the initial administration of vedolizumab: infliximab (8 weeks before) adalimumab (2 weeks before) golimumab (4weeks before) JAK inhibitor (1 week before) ustekinumab (8 weeks before)
- •5. Subjects who had prior exposure to vedolizumab natalizumab efalizumab or rituximab (any time before)
- •6. Subjects who had any evidence of an active infection within 1 month prior to the first administration of vedolizumab
- •7. Subject with a history of hypersensitivity or allergies to vedolizumab or its components (subjects with contraindication in the vedolizumab package insert)
- •8. Subjects with concurrent malignancies who are deemed unsuitable for enrollment by the investigator
- •9. Patients who have been determined to be inappropriate as subjects in the study by the investigator
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