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: 17.0Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2011-002411-29-GB

Lead Sponsor: Abbvie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 455

Inclusion Criteria

1. Subjects must be male or female between the ages of 18 and 75 years old at the time of the Screening Visit.
2. Subjects must have a diagnosis of Ulcerative Colitis (UC) greater than 90 days prior to Week 0 (Baseline) and failed conventional treatment.
3. Subjects' diagnosis of active UC must be confirmed by a colonoscopy with biopsy or flexible sigmoidoscopy with biopsy.
4. Subjects must have active UC with a Physicians Global Assessment (PGA) score of 2 or 3 and Short Inflammatory Bowel Disease
Questionnaire (SIBDQ) = 45 at Week 0 (Baseline).
5. Subjects must be on a concurrent treatment with at least one of the following (oral corticosteroids or immunosuppressants or both as defined below):
? Stable oral corticosteroid dose (prednisone = 20 mg/day or equivalent) for at least 14 days prior to Baseline.
or
? Stable oral corticosteroid dose (prednisone < 20 mg/day) for at least 21 days prior to Baseline.
and/or
? At least a consecutive 12 weeks (84 days) course of azathioprine or 6-mercaptopurine (6-MP) prior to Baseline.

Concurrent therapy will not be required for subjects who were previously treated with corticosteroids or immunosuppressants
(azathioprine or 6-MP) and, in the judgment of the investigator, have failed to respond to or could not tolerate their treatment.
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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

Exclusion Criteria

1. Subjects with a history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch, or ileostomy for UC or
planned bowel surgery.
2. Subjects received previous treatment with adalimumab or previous participation in an adalimumab clinical study.
3. Subjects who have previously used infliximab or any anti-TNF agent within 56 days of Baseline (Week 0).
4. Subjects who have previously used infliximab or any anti-TNF agent and have not clinically responded at any time (primary non-reponder)
unless they experienced a treatment limiting reaction.
5. Subjects received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days of Week 0 (Baseline).
6. Subjects received intravenous (IV) corticosteroids within 14 days of Screening or during the Screening period.
7. Subjects with a current diagnosis of fulminant colitis and/or toxic megacolon.

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<br>- Change (6 months after versus the previous 6 months) in costs of UC-related medical care excluding adalimumab costs;Timepoint(s) of evaluation of this end point: Week 0, Week 2, Week 8, Week 26/Premature Discontinuation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Key Secondary:<br>• Change (6 months after versus the past 6 months) in total all-cause direct health care costs<br>• Change (6 month after versus the past 6 months) in direct UC-related health care costs and indirect UC-related health care costs<br>• Change (6 months after versus the past 6 months) in UC-related and all-cause hospitalization<br>• Change in patient satisfaction (TSQM) at Week 26 from Baseline;Timepoint(s) of evaluation of this end point: 6 months prior to Baseline, Week 0, Week 2, Week 8, Week 26/Premature Discontinuation

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