Ulcerative Colitis

Why is this study being conducted?

There is broad support for the hypothesis that Ulcerative colitis is an auto-immune disease. Rituximab is an antibody protein that removes a subgroup of white blood cells (B lymphocytes) from the circulation. These cells have the capacity to generate the auto-antibodies that typify auto-immune disease. Although Rituximab has been mainly used for treating B lymphocyte malignancies (lymphoma) it has also been used with promising results in Rheumatoid arthritis and has an excellent safety recortd. This is a small placebo-controlled trial to assess its efficacy and safety in patients with steroid-resistant active ulcerative colitis.

What are the main eligibility criteria?

Inclusion Criteria:

• Patients over age of 18 years who are capable of providing written informed consent
• Confirmed diagnosis of ulcerative colitis by conventional clinical, endoscopic and histological criteria
• Failure of response to at least two weeks of oral prednisolone 40mg/day

Exclusion Criteria:

Patients will be excluded from the study if they:

• Patients under 18 or unable to give informed consent
• Patients in their first attack of ulcerative colitis
• Patients with a stoma
• Patients who are pregnant, post partum (<3months) or breast feeding

Important

If you are interested in participating in a clinical trial, please register and you will be contacted by the study coordinator or person involved with the specific trial you are interested in.

• Prior to your participation a physician will inform you about the process in detail and examine if you are eligible to take part in the study.
• If you are to participate all medication will be free.
• Of course you can terminate during the process any time.

References:

Trial information was taken from the following sites:

• http://www.clinicaltrials.gov/ct2/show/NCT00261118
• In ClinLife opinion the main facts were taken and centralized. ClinLife isn´t liable for defects or wrong translation.
• Official Title: Phase 3: Randomised Controlled Trial of Rituximab in Active Ulcerative Colitis