NL-OMON52419招募中4 期
Control Crohn Safe with episodic adalimumab monotherapy as first line treatment study. - CoCroS trial
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 158
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 64（—）
入选标准
- •- Newly diagnosed CD patients or patients with a flare of an established
- •diagnosis visiting the outpatient clinic or endoscopy ward of the participating
- •- CD diagnosis according to ECCO-guidelines including complete ileo-colonoscopy
- •(last endoscopy <12 months ago) + complete small bowel imaging at diagnosis
- •(MRI or CT-enterography)
- •- naïve to biologicals
- •- Sufficient knowledge Dutch language
- •- 18 years old <= 70 years old
- •- Smartphone with internet access
- •- Use of myIBDcoach
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study:
- •- Use of prednisone for longer than 4 weeks in the year before screening
- •- Use of budesonide (>=6 mg daily) for a duration longer than 3 months in the
- •year before screening
- •- Use of thiopurines in the 3 years before screening
- •- Indication for primary treatment with biologicals or surgery
- •- Malignancy in 5 years before treatment. Exception adequately treated
- •non-melanoma skin cancer
- •- Contra-indication for an TNF-blocker or immunosuppressant treatment.
- •(Contra-indications are: a symptomatic stricture, an abscess, a history of
- •tuberculosis or other granulomatous infection, a positive chest radiograph or
- •Quantiferon or tuberculin skin test with purified protein derivative, a recent
- •history of an opportunistic infection (within the previous 6 months), active
- •infection with hepatitis B or C, infection with the human immunodeficiency
- •virus, multiple sclerosis, cancer (except adequately treated non melanoma skin
- •- Contra-indication for MRI-and CT-enterography
- •- Patients with short bowel syndrome or an ostomy
研究者
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