Clinical trial 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: Quality of Life
Costs of Ulcerative Colitis
Health Care Utilization
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-03-12
Enrollment: 463
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Participants had to be a male or female between the ages of 18 and 75 years old at the time of the Screening Visit.
2. Participants who had a diagnosis of ulcerative colitis (UC) greater than 90 days prior to baseline (week 0) and failed conventional treatment.
3. Participants diagnosis of active UC was confirmed by a colonoscopy with biopsy or flexible sigmoidoscopy with biopsy.
4. Participants who had active UC with a Physicians Global Assessment (PGA) score of 2 or 3 and Short Inflammatory Bowel Disease Questionnaire (SIBDQ) ≤ 45 at baseline (week 0).
5. Concurrent therapy was required for participants who were previously treated with corticosteroids or immunosuppressants (azathioprine (AZA) or 6-mercaptopurine (6-MP)) and, in the judgment of the investigator, had failed to respond to or could not tolerate their treatment. Participants had to 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 AZA or 6-MP prior to baseline.

Exclusion Criteria:

1. Participants who had a history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch, or ileostomy for UC or planned bowel surgery.
2. Participants received previous treatment with adalimumab or previous participation in an adalimumab clinical study.
3. Participants who had previously used infliximab or any anti- tumor necrosis factor (TNF) agent within 56 days of baseline (week 0).
4. Participants who had previously used infliximab or any anti-TNF agent and had not clinically responded at any time ("primary non-responder") unless they experienced a treatment limiting reaction.
5. Participants who had received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days of baseline (week 0).
6. Participants who had received intravenous (IV) corticosteroids within 14 days of Screening or during the screening period.
7. Participants who had a current diagnosis of fulminant colitis and/or toxic megacolon.

Primary outcomes:
measure: Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score
timeFrame: Week 0 (baseline) and Week 26
measure: Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in Costs of UC-related Medical Care Excluding Adalimumab Costs
timeFrame: 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)
Secondary outcomes:
measure: Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in Total All-cause Direct Health Care Costs (Excluding Adalimumab Costs)
timeFrame: 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)
measure: Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related Direct and Indirect Health Care Costs
timeFrame: 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)
measure: Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related and All-cause Hospitalization
timeFrame: 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)
measure: Mean Change From Baseline in Participant's Satisfaction Using Treatment Satisfaction Questionnaire for Medication (TSQM)
timeFrame: Week 0 (baseline) and Week 26
measure: Mean Change From the 6 Months Prior to Treatment With Adalimumab to the 6 Months After Beginning Treatment With Adalimumab in UC-related Outpatient Utilization, Including Emergency Department Visits, Unscheduled Consultation, Exam Procedures
timeFrame: 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)
measure: Percentage of Participants With Absence of Blood in Stool
timeFrame: Week 26
measure: Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score Over Time
timeFrame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
measure: Mean Change From Baseline in Physician's Global Assessment (PGA)
timeFrame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
measure: Mean Change From Baseline in Total Simple Clinical Colitis Activity Index (SCCAI)
timeFrame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
measure: Mean Change From Baseline in European Quality of Life - 5 Dimensions - 5 Level (EQ-5D-5L) Total Score
timeFrame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
measure: Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Work Time Missed
timeFrame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
measure: Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Impairment While Working
timeFrame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
measure: Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Overall Work Impairment Percentage
timeFrame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
measure: Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Activity Impairment
timeFrame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: John Medich
role: STUDY_DIRECTOR
References:
citation: Travis S, Feagan BG, Peyrin-Biroulet L, Panaccione R, Danese S, Lazar A, Robinson AM, Petersson J, Pappalardo BL, Bereswill M, Chen N, Wang S, Skup M, Thakkar RB, Chao J. Effect of Adalimumab on Clinical Outcomes and Health-related Quality of Life Among Patients With Ulcerative Colitis in a Clinical Practice Setting: Results From InspirADA. J Crohns Colitis. 2017 Oct 27;11(11):1317-1325. doi: 10.1093/ecco-jcc/jjx093.