Herica - Histological and Endoscopic evaluation of Remission induced by Infliximab in moderately to severely active ulcerative Colitis Patients - Herica

• Conditions: 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: 16.0Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856

• Registration Number: EUCTR2009-013890-16-PT
• Lead Sponsor: GEDII - Grupo de Estudo da Doença inflamatória Intestinal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-21
• Last Update Posted: 19 August 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified