Phase 3
Completed N=463
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
Source: ClinicalTrials.gov NCT01550965 ↗Enrolled (actual)
463
Serious AEs
14.5%
Results posted
Nov 2016
Primary outcomePrimary: Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score — 17.4 units on a scale — p=<0.001
◆ Published Evidence
Established
44citations · ~5 / year
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.
Summary
This study evaluated the quality of life (QOL) and economic impact of adalimumab treatment in participants with ulcerative colitis (UC).
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score |
17.4 | <0.001 sig |
| PRIMARY 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 |
-1383.8 | <0.001 sig |
| SECONDARY 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) |
-1297.8 | <0.001 sig |
| SECONDARY 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 |
-4308.3 | <0.001 sig |
| SECONDARY 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 |
-7.3 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Participant's Satisfaction Using Treatment Satisfaction Questionnaire for Medication (TSQM) |
24.4; 18.9; 6.2; 22.6 | <0.001 sig |
| SECONDARY 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 |
-4.8; 0.0; -0.9 | <0.001 sig |
| SECONDARY Percentage of Participants With Absence of Blood in Stool |
56.6 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score Over Time |
11.1; 15.4; 14.8; 17.4 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Physician's Global Assessment (PGA) |
-0.6; -1.1; -0.9; -1.1 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Total Simple Clinical Colitis Activity Index (SCCAI) |
-3.2; -4.1; -3.0; -4.1 | <0.001 sig |
| SECONDARY Mean Change From Baseline in European Quality of Life - 5 Dimensions - 5 Level (EQ-5D-5L) Total Score |
0.1; 0.1; 0.1; 0.1 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Work Time Missed |
-8.6; -12.2; -11.6; -11.4 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Impairment While Working |
-16.6; -22.9; -21.7; -24.5 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Overall Work Impairment Percentage |
-18.3; -26.5; -25.3; -29.2 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Activity Impairment |
-18.2; -25.4; -24.4; -27.2 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Participants had to be a male or female between the ages of 18 and 75 years old at the time of the Screening Visit.
- Participants who had a diagnosis of ulcerative colitis (UC) greater than 90 days prior to baseline (week 0) and failed conventional treatment.
- Participants diagnosis of active UC was confirmed by a colonoscopy with biopsy or flexible sigmoidoscopy with biopsy.
- 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).
- 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
- 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.
- Participants received previous treatment with adalimumab or previous participation in an adalimumab clinical study.
- Participants who had previously used infliximab or any anti- tumor necrosis factor (TNF) agent within 56 days of baseline (week 0).
- 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.
- Participants who had received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days of baseline (week 0).
- Participants who had received intravenous (IV) corticosteroids within 14 days of Screening or during the screening period.
- Participants who had a current diagnosis of fulminant colitis and/or toxic megacolon.
Data sourced from ClinicalTrials.gov (NCT01550965) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.