Feasibility and safety of Infliximab enema treatment in patients with active left-sided ulcerative colitis. An open-label, non comparative, pilot study. - ND

• Conditions: lcerative colitis; MedDRA version: 9.1Level: SOCClassification code 10017947Term: Gastrointestinal disorders

• Registration Number: EUCTR2007-007702-30-IT
• Lead Sponsor: COSMO TECHNOLOGIES LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

- Patients, 18-75 years old with left sided ulcerative colitis for more than 6 months. - Diagnosis of active left sided ulcerative colitis confirmed at colonoscopy, with a moderate disease activity, as indicated by an Clinical Activity Index (CAI)≥6≤10. - Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Signs or synptoms of severe or fulminant ulcerative colitis or a history of toxic megacolon. - Presence of isolated proctitis, infectious colitis or presence of Clostridium difficile toxins in stool. - Evidence of colonic dysplasia - Patients with positive PPD skin test, Chest X-Ray suspect for tuberculosis. - Severe anemia or leucopenia, liver impairment or heart function. - Severe diseases involved other organs systems and history of neoplasia. - Presence of Hepatitis B, C, CMV or HIV infection.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified