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

Active, not recruiting

Conditions: Active Moderate to Severe Ulcerative Colitis
MedDRA version: 14.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1Level: LLTClassification code 10033007Term: Other ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1Level: LLTClassification code 10045366Term: Ulcerative colitis, unspecifiedSystem Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 10017947 - Gastrointestinal disorders

Registration Number: EUCTR2009-010065-23-DE

Lead Sponsor: Essex Pharma GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.