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

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

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.

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.

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.