NL-OMON46754已完成4 期
A proSpective randomized controlled trial comParing infliximAb-antimetabolites combination therapy to anti-metabolites monotheRapy and infliximab monothErapy in Crohn*s disease patients in sustained steroid-free remission on combination therapy. - GETAID 2014-3 SPARE
Groupe dEtude Thérapeutique dans les Affections Inflammatoires Digestives (GETAID)0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
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
- 18 至 99（—）
入选标准
- •* Diagnosis of Crohn's disease.
- •* Male or female, age > 18 years.
- •* Currently treated with a combination therapy with infliximab and anti-metabolites for luminal Crohn's disease.
- •* Combined therapy with scheduled infliximab and anti-metabolites for at least 8 months.
- •* Scheduled administration of infliximab 5 mg/Kg every 8 weeks over the last 4 months.
- •* Antimetabolites administered at a stable dosage for the last 3 months: at least 1 mg/Kg or 2 mg/Kg for mercaptopurine and azathioprine, respectively, or the highest tolerated dosage if intolerance to standard dose (lower dose than standard dose is also allowed if 6 TGN
- •> 235 pmol) ; at least 15 mg/week subcutaneously for methotrexate.
- •* Patients in steroid free clinical remission for at least 6 months according to retrospective assessment of the patients' files.
- •* CDAI < 150 at baseline.
- •* A contraceptive during the whole study for childbearing potential female patients.
- •* Patients able to understand the information provided to them and to give written informed consent for the study
排除标准
- •* Patients who have presented a severe acute or delayed reaction to infliximab.
- •* Perianal fistulae as the main indication for infliximab treatment
- •* Active perianal/abdominal fistulae at time of inclusion, defined by active drainage
- •* Patients with ostomy or ileoanal pouch
- •* Pregnancy or planned pregnancy during the study
- •* Inability to follow study procedures as judged by the investigator
- •* Non-compliant subjects.
- •* Participation in another therapeutic study
- •* Steroid use *6 months prior to screening
- •* Currently receiving steroids, immunosuppressive agents (other than purine, methotrexate), biologic treatment (other than infliximab) or thalidomide
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