Active Moderate to Severe Ulcerative Colitis MedDRA version: 14.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: LLT Classification code 10033007 Term: Other ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: LLT Classification code 10045366 Term: Ulcerative colitis, unspecified System Organ Class: 10017947 - Gastrointestinal disor
Conditions
Interventions
Trade Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: infliximab
Other descriptive name: 100
Concentration unit: mg milligram(s)
Concentration
Sponsors
Essex Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to show superiority of infliximab monotherapy (Top-Hold regimen) versus the classical Step-Up therapy with respect to the proportion of subjects with moderate to severe active UC who achieve response within 4 weeks after starting treatment and steroid free remission at week 50.;Secondary Objective: Comparison of the two treatment groups with regard to: • Proportion of subjects with response at week 4 • Proportion of subjects in remission at week 50 • Proportion of subjects off steroids at week 50 • Corticosteroid use over the trial duration • Proportion of subjects in remission and off steroids and with no surgery at week 50 • Mucosal healing at week 50 • Clinical assessment of disease activity (Mayo score) • QoL as measured by IBDQ • Proportion of subjects with hospitalizations • Proportion of subjects with colectomy during the study • Proportion of subjects with Level 3 treatment1 • Number of flares and time to flare • Safety profile;Primary end point(s): The primary efficacy endpoint for this trial is the proportion of subjects with moderate to severe active UC who achieve response within 4 weeks after starting treatment and steroid free remission at week 50. | — |
Countries
Germany
Outcome results
None listed