Comparison of Azathioprine to Methotrexate in Combination Therapy With Adalimumab in Crohn's Disease: an Open-label Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Variation of the endoscopic response between AZA and MTX groups
研究概览
简要总结
Combination therapy, the association of an anti-Tumor Necrosis Factor (TNF) to an immunosuppressant, is recognized as the most effective treatment during Crohn's disease (CD). Several mechanisms have been proposed to explain the superiority of combination therapy over monotherapy, the additive effect of two effective drugs or the prevention of anti-TNF immunogenicity. As the best combination therapy is unknown, both azathioprine (AZA) and methotrexate (MTX) are used. Some retrospective studies suggest a higher effectiveness of AZA. MTX may have an advantage in terms of safety.
The investigators hypothesize that AZA is more effective than MTX as combination therapy with adalimumab to improve short-term endoscopic, clinical and pharmacological outcomes in CD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients with age > 18 years
- •Crohn's disease for at least 6 weeks,
- •Clinically active with CDAI > 150
- •Active inflammation by endoscopy (CDEIS > 4) at baseline
- •Not responder to conventional therapy or are intolerant to or have medical contraindications for such therapies and initiating treatment with adalimumab
- •Patient followed in a center belonging to the GETAID network
- •Fertile men and women of childbearing potential included in the protocol should use adequate methods of contraception according to study drug SMPCs.
- •Written consent
排除标准
- •Short bowel syndrome, ostomy, symptomatic stricture, abscess, recent history of abdominal surgery (<3 months)
- •Non-passable colonic stricture
- •Previous intolerance to thiopurines or MTX
- •Previous exposition to adalimumab
- •Contra-indication to immunosuppressants or anti-TNF
- •Others serious simultaneous illness that could interfere with study participation
- •Planning pregnancy, pregnancy or lactation or absence of contraception
- •Known substance abusers
- •Use of any investigational drug within 30 days
- •Adults protected by law
研究组 & 干预措施
AZA group
Combination of sub-cutaneous administration of adalimumab at a dose of 160mg(W0)-80mg(W2)-40mg(W6) and then 40mg EOW and oral AZA capsules at a daily dose of 2.5 mg/kg
干预措施: AZA capsules (Drug)
AZA group
Combination of sub-cutaneous administration of adalimumab at a dose of 160mg(W0)-80mg(W2)-40mg(W6) and then 40mg EOW and oral AZA capsules at a daily dose of 2.5 mg/kg
干预措施: blood sample (Biological)
MTX group
Combination of sub-cutaneous administration of adalimumab at a dose of 160mg (week (W) 0)-80mg(W2)-40mg(W6) and then 40mg EOW and sub-cutaneous MTX 25mg once a week
干预措施: MTX (Drug)
MTX group
Combination of sub-cutaneous administration of adalimumab at a dose of 160mg (week (W) 0)-80mg(W2)-40mg(W6) and then 40mg EOW and sub-cutaneous MTX 25mg once a week
干预措施: blood sample (Biological)
结局指标
主要结局
Variation of the endoscopic response between AZA and MTX groups
时间窗: 26 weeks
Variation of the endoscopic response to AZA in combination with adalimumab and to MTX in combination with adalimumab in patients with CD. The endoscopic reference score (EREFS) is used to determine severity of 5 endoscopic findings: edema, rings, exudates, furrows, and structures. The EREFS classification system rates the severity of edema (0-2), rings (0-3), exudates (0-2), furrows (0-2), and strictures (0-1)
次要结局
未报告次要终点