A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

Conditions: lcerative Colitis
MedDRA version: 14.0Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2011-002411-29-GR

Lead Sponsor: Abbott GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 680

Inclusion Criteria

• Subjects must be male or female between the ages of 18 and 75 years old at Week 0 (Baseline).
• Subjects must have a diagnosis of UC for greater than 90 days prior to Week 0 (Baseline).
• Subjects' diagnosis of active UC must be confirmed by a colonoscopy with biopsy or flexible sigmoidoscopy with biopsy (refer to Section 5.3.1.1 for the criteria to perform a flexible sigmoidoscopy).
• Subjects must have active UC with a PGA score of 2 or 3 and SIBDQ = 45 at Week 0 (Baseline).
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 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

• Subjects with a history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch, or ileostomy for UC or planned bowel surgery or diagnosis of fulminant colitis and/or toxic megacolon or current diagnosis of indeterminate colitis or Crohn's disease.
• Subjects with disease limited to the rectum.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assess the effect of adalimumab on QOL as measured by the Short Inflammatory Bowel Disease (SIBDQ), the utilization of health care resources and the costs of care for the UC subjects treated with adalimumab.;Secondary Objective: Assess the effect of adalimumab on UC subjects' additional QOL measurements and disease activities, as well as to further characterize the safety profile of adalimumab.;Primary end point(s): Change in SIBDQ at Week 26 from Baseline;Timepoint(s) of evaluation of this end point: Week 0, Week 2, Week 8, Week 26/Premature Discontinuation

Secondary Outcome Measures