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

Sponsor
AbbVie (prior sponsor, Abbott)
Study ID
NCT01550965
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — BIOLOGICAL
    Adalimumab pre-filled syringe, administered by subcutaneous injection

Study Details

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

Key Dates

Start date
May 31, 2012
Status verified
May 2016
Primary completion
Apr 30, 2015
Completion
Apr 30, 2015

Study Design

Enrollment
463 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants Receiving Adalimumab
    Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.

Primary Outcome Measure

Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score [ Time Frame: Week 0 (baseline) and Week 26 ]

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