Ulcerative Colitis MedDRA version: 14.1 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Sponsors
AbbVie Deutschland GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 55
Exclusion criteria
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 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-responder") 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 -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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary: • Change (6 months after versus the past 6 months) in total all-cause direct health care costs • Change (6 months after versus the past 6 months) in direct UC-related health care costs and indirect UC-related health care costs • Change (6 months after versus the past 6 months) in UC-related and all-cause hospitalization • 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 | — |
Countries
Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Israel, Italy, Norway, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom
Contacts
Public ContactEU Clinical Trials Helpdesk
AbbVie Ltd.
Outcome results
None listed