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

• Register: EUCTR
• Last refreshed on: 1 May 2012
• Main ID: EUCTR2009-010065-23-DE
• Date of registration: 14/04/2009
• Prospective Registration: Yes
• Primary sponsor: Essex Pharma GmbH
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 17/08/2009
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-010065-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: yes Other specify the comparator: therapy design

Countries of recruitment

Germany

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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 disorders
MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders

Intervention(s)

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 type: equal
Concentration number: 100-

Trade Name: Pentasa 500 mg Retardtabletten
Product Name: 5-Aminosalicylic acid (5-ASA)
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: 5-Aminosalicylic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-

Trade Name: Imurek 25mg Filmtabletten
Pharmaceutical Form: Coated tablet
INN or Proposed INN: azathioprine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Trade Name: Imurek 50mg Filmtabletten
Pharmaceutical Form: Coated tablet
INN or Proposed INN: azathioprine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: Decortin H 1 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: prednisolone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

Trade Name: Decortin H 5mg
Pharmaceutical Form: Tablet
INN or Proposed INN: prednisolone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-

Trade Name: Decortin H 10mg
Pharmaceutical Form: Tablet
INN or Proposed INN: prednisolone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Trade Name: Decortin H 20mg
Pharmaceutical Form: Tablet
INN or Proposed INN: prednisolone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Trade Name: Decortin H 50 mg
Pharmaceutical Form: Tablet
INN or Proposed INN: prednisolone
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

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

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.

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.

Secondary ID(s)

P05553