This national, multi-centre, open-label pilot study will assess the histologic remission in patients with moderate to severe active ulcerative colitis under infliximab treatment who have had an inadequate response to conventional therapy. Biopsies will be analyzed throughout the study in order to assess histological disease modifying effects in those patients. MedDRA version: 16.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Interventions
Trade Name: Remicade
Product Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion
Sponsors
GEDII - Grupo de Estudo da Doença inflamatória Intestinal
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1- Must be eligible to start infliximab treatment according to the Portuguese approved Summary of Product Characteristics 2- Patients older than 18 years of age up to 65 years of age at the time of informed consent, of both gender and any race. 3- Patients with moderate to severe UC - Mayo Score (6-12); endoscopic subscore =2 4.1 Patients must have responded inadequately to corticosteroids at least a dose of 40mg/day with or without 5-ASA or patients steroid-dependent 4.2- Patients must have responded inadequately to azathioprine or 6-MP (treatment with thiopurines must be at least 3 months in duration) or be intolerant to these agents. 5- Patients must be naïve to infliximab or other anti-TNF agents 6- No history of latent or active TB prior to screening. No signs or symptoms suggestive of active TB upon medical history and/or physical examination. 7- Patients must be capable of providing written informed consent prior to trial entry. 8- Subjects must be willing and able to adhere to visit protocol schedule and procedures. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1- Any "Contraindication" as specified in the Portuguese infliximab approved Summary of Product Characteristics (See Supplement 15.3) 2- Patients with severe anemia (haemoglobin<8.0 g/dL) 3- Any malignancy in the past 5 years, including lymphoproliferative disorders 4- Existence of not removed adenomatous polyps 5- History of opportunistic infections in the last 6 months 6- Subjects who have a known viral infection such as CMV, HIV, HBV or HCV 7- Patients with a history of demyelinating diseases 8- Pregnant or breastfeeding women 9- Topical treatment with 5-ASA and steroids 10-Patients with only rectal involvement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1-To assess if infliximab is able to induce histological remission in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy, including corticosteroids and 6-MP/AZA or who are intolerant or have medical contraindications for such therapies using Geboes criteria at week 8. 2- To assess the clinical response in the above patients assessed by Mayo Score at week 8.;Secondary Objective: 1- Assess time of first documented histological remission 2- Correlate histological remission with: 2.1 Mucosal healing 2.2 Faecal calprotectin and lactoferrin levels 2.3 Number of colectomies up to week 52 2.4 Number of hospitalizations up to week 52 2.5 Number of clinical relapses up to week 52 ;Primary end point(s): Clinical response was defined as a decrease from baseline in the total Mayo score of at least 3 points and at least 30 percent from the baseline value, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or an absolute subscore for rectal bleeding of 0 or 1. Clinical remission was defined as a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point. | — |
Countries
Portugal
Outcome results
None listed