Status:
COMPLETED
Evaluation of Histologic and Endoscopic Remission Induced by Infliximab in Moderate to Severe Ulcerative Colitis
Lead Sponsor:
Grupo de Estudo da Doença Inflamatória Intestinal
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-64 years
Phase:
PHASE4
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 pr...
Detailed Description
Correlations between histologic disease activity and other assessments of clinical disease activity are not well established despite a good correlation being found between endoscopy and histology, esp...
Eligibility Criteria
Inclusion
- Subjects must meet all the following inclusion criteria to be considered eligible:
- 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:
- 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.
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01408810
Start Date
February 1 2011
End Date
November 1 2012
Last Update
December 18 2012
Active Locations (1)
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1
Hospital de São João
Porto, Porto District, Portugal, 4200-319