Study of Effects and of Modifications in Apoptosis Regulators Observed After Stopping 5-ASA Treatment in Patients With Inactive Ulcerative Colitis

Study Overview
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Brief Summary
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Male or female, 18 years of age or older. Ulcerative Colitis described according usual criteria, diagnosed for at least 1 year. Oral maintenance treatment with 5-aminosalicylic acid (5-ASA) only for at least 3 months with a dosage of 2 to 3 g/day. Clinical remission for at least 3 months (Mayo Clinic score) and endoscopic remission (endoscopic score of Mayo Clinic) at the inclusion. Signed informed consent form.

Detailed Description
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Inclusion Criteria: Male or female, 18 years of age or older. Ulcerative colitis described according to usual criteria, diagnosed for at least 1 year. Oral maintenance treatment with 5-aminosalicylic acid (5-ASA) only for at least 3 months with a dosage of 2 to 3 g/day. Clinical remission for at least 3 months (Mayo Clinic score) and endoscopic remission (endoscopic score of Mayo Clinic) at inclusion. Signed informed consent form. Exclusion Criteria: Patients allergic to aspirin or salicylates derivatives Patients taking the following treatments during the study will be excluded: corticosteroids (oral or rectal route), use of NSAID or Aspirin, any form of sulfasalazine, mesalazine or 4-ASA. Patients with known significant hepatic or known function abnormalities and/or creatine clearance ≤ 80 ml/min. Patients with history or physical examination findings indicative of active alcohol or drug abuse. Women who are pregnant or nursing. Patients with a history of disease, including mental/emotional disorder that would interfere with their participation in the study. Patients who participated in another clinical study in the last 3 months. Patients who are unable to comply with the requirements of the protocol Female of childbearing potential without efficacious contraception.

Official Title
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Study of Histological Modifications, of Pro-apoptotic Effects and of Modifications in Apoptosis Regulators Observed After Stopping 5-ASA Treatment in Patients With Inactive Ulcerative Colitis (Clinical and Endoscopic Remission) Taking 5-ASA

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Behavioral: Observe patients with inactive ulcerative colitis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 18 years of age or older. Ulcerative colitis described according to usual criteria, diagnosed for at least 1 year. Oral maintenance treatment with 5-ASA only for at least 3 months with a dosage of 2 to 3 g/day. Clinical remission for at least 3 months (Mayo Clinic score) and endoscopic remission (endoscopic score of Mayo Clinic) at inclusion. Signed informed consent form. Exclusion Criteria: Patients allergic to aspirin or salicylates derivatives Patients taking the following treatments during the study will be excluded: corticosteroids (oral or rectal route), use of NSAID or Aspirin, any form of sulfasalazine, mesalazine or 4-ASA. Patients with known significant hepatic or known function abnormalities and/or creatine clearance ≤ 80 ml/min. Patients with history or physical examination findings indicative of active alcohol or drug abuse. Women who are pregnant or nursing. Patients with a history of disease, including mental/emotional disorder that would interfere with their participation in the study. Patients who participated in another clinical study in the last 3 months. Patients who are unable to comply with the requirements of the protocol Female of childbearing potential without efficacious contraception.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Observe patients with inactive ulcerative colitis|Observe patients with inactive ulcerative colitis|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change between rectal biopsies performed at D1 and D28 of proliferative index |  | Its aim was to study histological modifications after Pentasa was stopped in non-active ulcerative colitis. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative Colitis for Maintenance of Remission