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: 15.1Level: SOCClassification code 10017947Term: Gastrointestinal disordersSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2011-002411-29-FI
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-11
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 680

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 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

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 an anti-tumor necrosis factor (TNF) agent (including infliximab or adalimumab) or previous participation in an adalimumab clinical study.
3. Subjects received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days of Week 0 (Baseline).
4. Subjects received intravenous (IV) corticosteroids within 14 days of Screening or during the Screening period.
5. 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