---
title: 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
nct_id: NCT01550965
overall_status: COMPLETED
phase: PHASE3
sponsor: AbbVie (prior sponsor, Abbott)
study_type: INTERVENTIONAL
primary_condition: Ulcerative Colitis
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01550965.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01550965"
ct_last_update_post_date: 2018-07-02
last_seen_at: "2026-05-12T06:31:38.285Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT01550965](https://clinicaltrials.gov/study/NCT01550965)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 463
- **Lead Sponsor:** AbbVie (prior sponsor, Abbott)
- **Conditions:** Ulcerative Colitis
- **Start Date:** 2012-05
- **Completion Date:** 2015-04
- **CT.gov Last Update:** 2018-07-02

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Participants Receiving Adalimumab** (EXPERIMENTAL) — 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.

## Interventions

- **Adalimumab** (BIOLOGICAL) — Adalimumab pre-filled syringe, administered by subcutaneous injection

## Primary Outcomes

- **Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score** _(time frame: Week 0 (baseline) and Week 26)_ — The SIBDQ is a disease-specific health-related quality of life (HRQOL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) participants by measuring physical, social and emotional status. The SIBDQ consists of 10 questions; each question is scored on a scale from 1 (poor QOL) to 7 (optimum QOL). A higher score indicates a better health-related quality of life. Total scores range from 10 (poor QoL) to 70 (good QoL).
- **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** _(time frame: 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months))_ — Medical care costs included, but were not limited to: surgical procedures, hospitalizations, bed days in hospital, unscheduled physician consultations, emergency room visits, unscheduled examination appointments, radiology appointments, endoscopy appointments and medications.

## Secondary Outcomes

- **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)** _(time frame: 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months))_
- **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** _(time frame: 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months))_
- **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** _(time frame: 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months))_
- **Mean Change From Baseline in Participant's Satisfaction Using Treatment Satisfaction Questionnaire for Medication (TSQM)** _(time frame: Week 0 (baseline) and Week 26)_
- **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** _(time frame: 6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months))_
- **Percentage of Participants With Absence of Blood in Stool** _(time frame: Week 26)_
- **Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score Over Time** _(time frame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26)_
- **Mean Change From Baseline in Physician's Global Assessment (PGA)** _(time frame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26)_
- **Mean Change From Baseline in Total Simple Clinical Colitis Activity Index (SCCAI)** _(time frame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26)_
- **Mean Change From Baseline in European Quality of Life - 5 Dimensions - 5 Level (EQ-5D-5L) Total Score** _(time frame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26)_
- **Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Work Time Missed** _(time frame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26)_
- **Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Impairment While Working** _(time frame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26)_
- **Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Overall Work Impairment Percentage** _(time frame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26)_
- **Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP): Percentage of Activity Impairment** _(time frame: Week 0 (baseline), Week 2, Week 8, Week 18, and Week 26)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01550965.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01550965*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*