EUCTR2011-003038-14-BE进行中（未招募）不适用
A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASE - TAILORIX
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- GETAID
- 入组人数
- 120
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
- •?Age > 18 years
- •Active CD (CDAI>220) and signs of active inflammation as evidenced by elevated serum hsCRP levels (>5 mg/L) and/or elevated fecal calprotectin levels (>250 µg/g) and endoscopically visible ulcers.
- •Patients must be naïve to biologics with indication for starting anti-TNF therapy in accordance with national reimbursement criteria.
- •Patients must be naïve to thiopurines or have failed therapy with 1 thiopurine; in which case AZA or 6MP will be continued: Patients previously intolerant to Azathioprine or 6-MP can start with the other thiopurine or with Methotrexate (MTX) per investigators discretion. Patient intolerant to standard doses of AZA or 6-MP can start at a lower dose per investigators discretion. However, the dose should remain stable for the duration of the trial, except if intolerance leading to discontinuation. ?
- •Patients failing MTX can continue on MTX with infliximab ?
- •Ongoing steroids are allowed if dose remains stable for at least 2 weeks, prior to screening until inclusion then tapered as per protocol and at a maximum of prednisone 40 mg/d or budesonide 9 mg/day?
- •Patients who consent to receiving Infliximab 5 mg/kg at week 0, 2 and 6 and further on every 8 weeks in conjunction with their current Azathioprine, 6-MP or MTX.
- •Adequate contraception for women of childbearing potential or their partner who must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last IFX treatment.
- •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 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Absence of endoscopically visible ulcers
- •Ongoing steroid therapy at doses > 40 mg/d prednisolone equivalent
- •Previous intolerance to Azathioprine and /or 6-MP or intolerance to one or both with impossibility to use the other drug or MTX (e.g. pancreatitis, severe leucopenia, hypersensitivity).
- •Ongoing infections
- •Prior use of biologic therapies
- •Serious other diseases including cancer in the 5 years prior to inclusion excluding non-melanoma skin cancer
- •Indication for immediate surgery
- •Critical gastrointestinal stricture with obstructive symptoms and/or presence of abscess.
- •Pregnant or breast-feeding woman.
- •Positive fecal culture for Salmonella, Shigella, Yersinia and Campylobacter and/or presence of Clostridium difficile B toxin in the stools
- •Active tuberculosis. Positive tuberculosis screen per local guidelines
- •Untreated latent tuberculosis (see national recommendations. Appendix 2), latent TB is allowed if treated for at least 6 months
- •Patients with moderate or severe heart failure
- •Patients with a history of hypersensitivity to infliximab, other murine proteins, or to any of the excipients.
- •HIV, HBV viral infection (except the presence of positive anti-HBs antibodies) with serology not older than 3 months.
- •Azathioprine or 6-MP in combination with allopurinol or with other myelotoxic therapy (a washout period of 7 days is required for allopurinol or other myelotoxic therapy)
- •Non-compliant subjects.
- •Participation in another therapeutic study
研究者
相似试验
进行中（未招募）
不适用
A RANDOMIZED CONTROLLED TRIAL INVESTIGATING TAILORED TREATMENT WITH INFLIXIMAB FOR ACTIVE LUMINAL CROHN'S DISEASEuminal active Crohn's DiseaseMedDRA version: 14.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersEUCTR2011-003038-14-NLGETAID120
尚未招募
不适用
small swelling on the wristCTRI/2018/10/016222Dr ESWARA REDDY G
尚未招募
不适用
Breakthrough pain after surgery under regional anaesthesiaCTRI/2021/08/035679Ganga Medical Centre and Hospital pvt ltd
进行中（未招募）
1 期
Determination of efficacy and safety of azithromycin maintenance therapy for 6 months in subjects with primary ciliary dyskinesiaPrimary ciliary dyskinesia (PCD)MedDRA version: 18.0Level: PTClassification code 10069713Term: Primary ciliary dyskinesiaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2013-004664-58-DEPaediatric Pulmonary Service, Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark125
进行中（未招募）
1 期
Determination of efficacy and safety of azithromycin maintenance therapy for 6 months in subjects with primary ciliary dyskinesiaPrimary ciliary dyskinesia (PCD)MedDRA version: 17.1Level: PTClassification code 10069713Term: Primary ciliary dyskinesiaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2013-004664-58-NLPaediatric Pulmonary Service, Department of Paediatrics and Adolescent Medicine, Rigshospitalet, Copenhagen, Denmark125