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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01408810 |
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Date of registration:
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20/07/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of Histologic and Endoscopic Remission Induced by Infliximab in Moderate to Severe Ulcerative Colitis
HERICA |
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Scientific title:
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Histological and Endoscopic Evaluation of Remission Induced by Infliximab in Moderately to Severely Active Ulcerative Colitis Patients |
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Date of first enrolment:
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February 2011 |
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Target sample size:
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21 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01408810 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Portugal
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Contacts
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Name:
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Paula Lago, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Geral de Santo António |
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Name:
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Paula Peixe, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centro Hospitalar Lisboa Ocidental - Hospital Egas Moniz |
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Name:
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Francisco Portela, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospitais da Universidade de Coimbra |
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Name:
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Susana Lopes, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital de São João |
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Name:
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José Cotter, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Nossa Senhora da Oliveira - Guimarães |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects must meet all the following inclusion criteria to be considered eligible:
1. Must be eligible to start infliximab treatment according to the Portuguese
approved Summary of Product Characteristics (SPC-See supplement 15.3)*
2. 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.
3. Patients with moderate to severe UC - Mayo Score (6-12); endoscopic subscore =2
4. Regarding the previous treatment exposure:
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.
- 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 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
Age minimum:
18 Years
Age maximum:
64 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: Infliximab
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Primary Outcome(s)
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histological remission
[Time Frame: histological remission were assessed at week 8]
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Clinical response
[Time Frame: clinical response were assessed at week 8]
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Secondary Outcome(s)
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Correlate histological remission with mucosal healing,faecal calprotectin and lactoferrin levels,number of colectomies,number of hospitalizations,Number of clinical relapses
[Time Frame: up to week 52]
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Histologic Efficacy assessment
[Time Frame: baseline, week 8, week 30 and week 52.]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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