NCT01550965

A 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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 463 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the quality of life (QOL) and economic impact of adalimumab treatment in participants with ulcerative colitis (UC).

Detailed description

This was a single arm, open-label, multicenter study. The primary objectives were to study the effect of adalimumab on QOL (as measured by Short Inflammatory Bowel Disease Questionnaire (SIBDQ)), the utilization of health care resources, and the costs of care for subjects with UC who were treated with adalimumab in the usual clinical practice setting. The secondary objectives were to further assess the effect of adalimumab on disease activity and to collect additional safety data in subjects with UC.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
BIOLOGICAL	Adalimumab	Adalimumab pre-filled syringe, administered by subcutaneous injection

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2012-03-12
• Last updated: 2018-07-02
• Results posted: 2016-11-01