Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIX

Essex Pharma GmbH0 个研究点开始时间: 2009年4月14日最近更新: 2012年5月1日

适应症

试验速览

暂无简介。

•1. Adult (=18 years) men and women with diagnosis of active UC for at least 3 months' duration (Mayo score of 6 to 12 points, inclusive) at the screening visit.
•2. A previous diagnosis of UC must have been confirmed by colonoscopy and biopsy.
•3. Inadequate response to oral (with or without topical) 5-ASA treatment and considered for the first course of systemic corticosteroids.
•4. Screening visit colonoscopy with biopsies must be performed within 2 weeks prior to the baseline. At least 72 hours must elapse between a colonoscopy with polypectomy or multiple biopsies and the baseline (week 0) visit.
•5. Evidence of active disease beyond the rectum and including more than 20 cm of the colon during the screening visit colonoscopy (Mayo score of = 2 on the endoscopy subscore of the Mayo score).
•6. Each subject must be negative for colorectal cancer or any associated lesions (e.g. hyperplasia).
•7. Each subject must have negative tuberculosis screening results.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Previous treatment for UC with systemic corticosteroids, infliximab, AZA/6-MP, cyclosporine, tacrolimus, methotrexate, sirolimus, mycophenolate, any TNFa inhibitor or receptor constructs that bind to ??Fa (e.g., etanercept or adalimumab) and any other biologic agents.
•2. Severe extensive colitis as evidenced by:
•a. Investigator judgment that the subject is likely to require colectomy within 12 weeks of the baseline visitOR
•b. Symptom complex at the screening or baseline visits, including at least four of the following:
•Diarrhea with = 6 bowel movements/day with macroscopic blood in stool,
•Focal severe or rebound abdominal tenderness,
•Persistent fever (= 37.5°C)
•Tachycardia (> 90 beats/minute)
•Anemia (Hb< 8.5 g/dL).
•3. Within the 2 months prior to and including the screening visit: Requirement for surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage or other conditions possibly confounding the evaluation of benefit from infliximab treatment.
•4. Presence of adenomatous polyps.

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