Evaluation of Histologic and Endoscopic Remission Induced by Infliximab in Moderate to Severe Ulcerative Colitis

NCT01408810 | Completed Phase 4

• 1 other identifier: P06120
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess the relationship between microscopic Geboes index of inflammation and clinical course of ulcerative colitis in patients treated with infliximab. The investigators propose to test the hypothesis if infliximab is able to induce histological remission and then change the clinical course of ulcerative colitis.

Conditions

Ulcerative Colitis

Keywords

infliximab; ulcerative colitis; histologic remission

Outcome Measures

Primary Outcomes (2)

• histological remission

  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

  histological remission were assessed at week 8

• Clinical response

  To assess the clinical response in the above patients assessed by Mayo Score at week 8

  clinical response were assessed at week 8

Secondary Outcomes (2)

• Histologic Efficacy assessment

  baseline, week 8, week 30 and week 52.

• Correlate histological remission with mucosal healing,faecal calprotectin and lactoferrin levels,number of colectomies,number of hospitalizations,Number of clinical relapses

  up to week 52

Study Arms (1)

Infliximab

EXPERIMENTAL

Infliximab 5 mg/Kg, I.V. at weeks 0, 2, 6 and every 8 weeks thereafter. The treatment should follow infliximab's Summary of Product Characteristics.

Drug: Infliximab

Interventions

Infliximab DRUG

5 mg/Kg, I.V. at weeks 0, 2, 6 and every 8 weeks thereafter

Also known as: Remicade

Infliximab

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Must be eligible to start infliximab treatment according to the Portuguese approved Summary of Product Characteristics (SPC-See supplement 15.3)\*
• Patients must be older than 18 years of age up to 65 years of age at the time of informed consent, of both gender and any race.
• Patients with moderate to severe UC - Mayo Score (6-12); endoscopic subscore ≥2
• Regarding the previous treatment exposure:
• 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.
• Patients must be naïve to infliximab or other anti-TNF agents
• 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.
• Patients must be capable of providing written informed consent prior to trial entry.
• Subjects must be willing and able to adhere to visit protocol schedule and procedures.
• Patients must have responded inadequately to corticosteroids at least a dose of 40mg/day with or without 5-ASA or patients steroid-dependent with a Mayo Score (6-12), endoscopic subscore \>2. Steroid-dependent is defined as: patients unable to reduce steroids below 10mg/day within 3 months of starting steroids and patients who have a relapse within 3 months of stopping steroids.

You may not qualify if:

• 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

Sponsors & Collaborators

• Grupo de Estudo da Doença Inflamatória Intestinal: lead

Study Sites (1)

Hospital de São João

Porto, Porto District, 4200-319, Portugal

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Susana Lopes, MD

  Hospital de São João

  PRINCIPAL INVESTIGATOR

• Francisco Portela, MD

  Hospitais da Universidade de Coimbra

  PRINCIPAL INVESTIGATOR

• Paula Lago, MD

  General Hospital of Santo António

  PRINCIPAL INVESTIGATOR

• José Cotter, MD

  Hospital Nossa Senhora da Oliveira - Guimarães

  PRINCIPAL INVESTIGATOR

• Paula Peixe, MD

  Centro Hospitalar Lisboa Ocidental Hospital Egas Moniz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: August 3, 2011
• Study Start: February 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 18, 2012

Record last verified: 2012-12

Locations

PT (1)