NL-OMON56467尚未招募不适用
Switching from intravenous to subcutaneous infliximab in adult patients with inflammatory bowel disease: evaluation of exposure parameters (SHUFFLE-study) - SHUFFLE-study
Zuyderland Medisch Centrum0 个研究点目标入组 36 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Adult patients (18-75 years) with an confirmed diagnosis of IBD according to
- •usual criteria, including previous endoscopic examination.
- •Patients on IV IFX maintenance therapy at a stable dose and dosing interval
- •for at least 16 weeks of 5-10 mg/kg every 6-8 weeks without side effects of IFX.
- •IBD in clinical remission for at least 16 weeks without treatment with
- •systemic corticosteroids in the previous 16 weeks. Clinical remission in adult
- •patients is defined as a Harvey-Bradshaw index (HBI) < 4 for CD [18] or a
- •partial Mayo Index (PMI) <2 for UC [19], with faecal calprotectin levels <250
- •µg/g faeces and CRP <10 mg/L.
- •Concomitant immunomodulators are allowed, i.e. in stable doses were received
- •for at least 12 weeks prior to study enrolment. These doses will be continued
- •throughout the study, including azathioprine (AZA), 6-mercaptopurine (6-MP),
- •tioguanine (TG) and MTX.
- •Written informed consent
排除标准
- •Patient <18 years of age.
- •Allergy or hypersensitivity to any of the excipients of SC CT-P13.
- •Patient with active perianal fistula.
- •Patient with another autoimmune disease in addition to IBD.
- •Patient treated concomitantly with another Mab in addition to IFX.
- •Patients who, after starting IV IFX, have developed new contraindications to
- •IFX according to European Public Assessment Report (EPAR).[3]
- •Female patient who is currently pregnant or breastfeeding, or is planning to
- •become pregnant or breastfeed within 6 months of the last dose of IFX.
- •Patient has a serious acute or chronic medical or psychiatric condition that
- •might increase the risk associated with study participation or investigational
- •product administration or that might interfere with the interpretation of study
- •Patients who, in the opinion of their general practitioner or investigator,
- •should not participate in the study (e.g. non-adherence, mental health
- •problems, illiteracy).
研究者
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