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

NCT01550965 | Completed Phase 3 Results

• 2 other identifiers: M13-0452011-002411-29
• Study Type: interventional
• Target: 463
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Ulcerative Colitis

Keywords

Quality of Life; Costs of Ulcerative Colitis; Health Care Utilization

Outcome Measures

Primary Outcomes (2)

• Mean Change From Baseline in Short Inflammatory Bowel Disease Questionnaire (SIBDQ): Total Score

  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).

  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 Costs of UC-related Medical Care Excluding Adalimumab Costs

  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.

  6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)

Secondary Outcomes (14)

• 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)

  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

  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

  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)

  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

  6 months prior to treatment start (Week 0 [baseline]) and 6 months after treatment start (total 12 months)

Study Arms (1)

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.

Biological: Adalimumab

Interventions

Adalimumab BIOLOGICAL

Adalimumab pre-filled syringe, administered by subcutaneous injection

Also known as: ABT-D2E7, Humira®

Participants Receiving Adalimumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Related Publications (1)

• 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.

  PMID: 28981846 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Colitis, Ulcerative; Patient Acceptance of Health Care

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Information
• Organization: AbbVie

800-633-9110

Study Officials

• John Medich

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2012
• First Posted: March 12, 2012
• Study Start: May 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: July 2, 2018
• Results First Posted: November 1, 2016

Record last verified: 2016-05