Ulcerative colitis MedDRA version: 9.1 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders
Conditions
Interventions
Trade Name: REMICADE
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: INFLIXIMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Sponsors
COSMO TECHNOLOGIES LTD
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate safety, feasibility and clinical efficacy of Infliximab enema, over a period of six weeks.;Secondary Objective: To evaluate the safety of the treatment until 180 days after the administration of Infliximab enema.;Primary end point(s): - Efficacy assessment: Clinical remission (CAI score after 6 weeks of observation), - Safety assessment: Local/general tollerability, laboratory safety, adverse events | — |
Countries
Italy
Outcome results
None listed