Rapidity of onset of response to Adalimumab in luminal Crohn's disease. RAPIDA study.

AbbVie Farmacéutica S.L.U.0 个研究点目标入组 100 人开始时间: 2014年2月25日最近更新: 2019年12月10日

适应症

试验速览

暂无简介。

•1. Crohn?s disease diagnosed within, at least, the previous 4 months.
•2. Patients with active luminal (Harvey-Bradshaw Index ?8) moderate-to-severe Crohn´s disease.
•3. Adult patient 18-75 year-old.
•4. No response to a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant.
•5. If receiving any of the following treatments, their dose should be stable during the periods indicated:
•? Aminosalicylates for, at least, the last 4 weeks
•? Probiotics for, at least, the last 4 weeks
•? Analgesics for, at least, the last 4 weeks
•? Antidiarrheals for, at least, the last 4 weeks
•? Oral budesonide (maximum dose of 9 mg/day) for, at least, the last 2 weeks
•? Oral prednisone or equivalent for, at least, the last 2 weeks
•? CD-related antibiotics for, at least, the last 4 weeks
•? Azathioprine, 6-mercaptopurine or methotrexate for, at least, the last 12 weeks
•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 88
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1. Previous treatment with any anti-TNF agent.
•2. Surgical bowel resection within the previous 6 months, ostomy, extensive bowel resection (> 100 cm), short bowel syndrome.
•3. Fistulising Crohn's disease.
•4. Treatment with cyclosporine or tacrolimus within the previous 8 weeks.
•5. Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months from screening, congestive heart failure of worse than grade II New York criteria (NYHA Functional Classification).
•6. Subject with an ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal anastomosis are not excluded).
•7. Proctocolectomy, total colectomy, ileostomy, stoma or ileal pouch-anal anastomosis.
•8. Screening laboratory values (according to central laboratory)
•9. Known of hepatitis C (HC) infection.
•10. Serologic evidence of hepatitis B (HB) infection* based on the results of testing for HBsAg, anti-HBc and anti-HBs antibodies as follows:

发起方

AbbVie Farmacéutica S.L.U.