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.

• Register: EUCTR
• Last refreshed on: 14 March 2016
• Main ID: EUCTR2011-002411-29-SE
• Date of registration: 13/10/2011
• Prospective Registration: Yes
• Primary sponsor: AbbVie Deutschland GmbH & Co. KG
• Public title: 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.
• Scientific title: An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A
• Date of first enrolment: 26/04/2012
• Target sample size: 455
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002411-29
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1

Countries of recruitment

Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Israel, Italy, Norway, Poland, Portugal, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom

Contacts

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd.

• Name: EU Clinical Trials Helpdesk
• Affiliation: AbbVie Ltd.

Key inclusion & exclusion 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 < 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 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Ulcerative Colitis
MedDRA version: 14.1 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders

Intervention(s)

Trade Name: Humira 40 mg solution for injection in pre-filled syringe
Product Name: adalimumab
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)

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.

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.

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.

Timepoint(s) of evaluation of this end point: Week 0, Week 2, Week 8, Week 26/Premature Discontinuation

Secondary Outcome(s)

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

Secondary ID(s)

M13-045

Source(s) of Monetary Support

AbbVie Inc.