A 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 (InspirAda)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01550965
First received: March 8, 2012
Last updated: April 8, 2014
Last verified: April 2014

March 8, 2012
April 8, 2014
May 2012
June 2014   (final data collection date for primary outcome measure)
  • Change in SIBDQ at Week 26 from Baseline [ Time Frame: Week 0, Week 2, Week 8, up to Week 26 or Premature Discontinuation ] [ Designated as safety issue: No ]
    The questionnaire is designed to help you find out how the subject's IBD symptoms affect his/her daily activities.
  • Change (6 months after versus the past 6 months) in costs of UC-related medical care excluding adalimumab costs [ Time Frame: 6 months prior to Baseline, Week 0, Week 2, Week 8, up to Week 26 or Premature Discontinuation ] [ Designated as safety issue: No ]
    Costs will be determined from the health care utilization information.
Change in SIBDQ at Week 26 from Baseline [ Time Frame: Week 0, Week 2, Week 8, up to Week 26 or Premature Discontinuation ] [ Designated as safety issue: No ]
The questionnaire is designed to help you find out how the subject's IBD symptoms affect his/her daily activities.
Complete list of historical versions of study NCT01550965 on ClinicalTrials.gov Archive Site
  • Change (6 months after versus the past 6 months) in total all-cause direct health care costs [ Time Frame: 6-months prior to Baseline, Week 0, Week 2, Week 8, up to Week 26 or Premature Discontinuation ] [ Designated as safety issue: No ]
    Costs will be determined from the health care utilization information
  • Change (6 months after versus the past 6 months) in direct UC-related health care costs and indirect UC-related health care costs [ Time Frame: 6-months prior to Baseline, Week 0, Week 2, Week 8, up to Week 26 or Premature Discontinuation ] [ Designated as safety issue: No ]
    Costs will be determined from the health care utilization information.
  • Change (6 months after versus the past 6 months) in UC-related and all-cause hospitalization [ Time Frame: 6-months prior to Baseline, Week 0, Week 2, Week 8, up to Week 26 or Premature Discontinuation ] [ Designated as safety issue: No ]
    Hospitalization will be determined from the health care utilization information and from Serious Adverse Event reporting
  • Change in patient satisfaction (TSQM) at Week 26 from Week 0 (Baseline) [ Time Frame: Week 0, Week 2, Week 8, Week 26 ] [ Designated as safety issue: No ]
    TSQM is a questionnaire to be completed by the subjects to determine their satisfaction of the medications for ulcerative colitis including the study drug.
  • Change (6 months after versus the past 6 months) in UC-related outpatient utilization, including emergency department visits, unscheduled consultation, exam procedures [ Time Frame: 6 months prior to Week 0, Week 0, Week 2, Week 8, up to Week 26 or Premature Discontinuation ] [ Designated as safety issue: No ]
    UC-related outpatient utilization will be determined from the health care utilization information
  • Change (6 months after versus the past 6 months) in costs of Ulcerative Colitis (UC)-related medical care excluding adalimumab costs [ Time Frame: 6-months prior to Baseline, Week 0, Week 2, Week 8, up to Week 26 or Premature Discontinuation ] [ Designated as safety issue: No ]
    Costs will be determined from the health care utilization information
  • Change (6 months after versus the past 6 months) in total all-cause direct health care costs [ Time Frame: 6-months prior to Baseline, Week 0, Week 2, Week 8, up to Week 26 or Premature Discontinuation ] [ Designated as safety issue: No ]
    Costs will be determined from the health care utilization information
  • Change (6 months after versus the past 6 months) in direct UC-related health care costs and indirect UC-related health care costs [ Time Frame: 6-months prior to Baseline, Week 0, Week 2, Week 8, up to Week 26 or Premature Discontinuation ] [ Designated as safety issue: No ]
    Costs will be determined from the health care utilization information
  • Reduction (6 months after versus the past 6 months) in direct UC-related and all-cause hospitalization [ Time Frame: 6-months prior to Baseline, Week 0, Week 2, Week 8, up to Week 26 or Premature Discontinuation ] [ Designated as safety issue: No ]
    Hospitalization will be determined from the health care utilization information and from Serious Adverse Event reporting
  • Change in patient satisfaction (Treatment Satisfaction Questionnaire for Medication [TSQM]) at Week 26 from Week 0 (Baseline) [ Time Frame: Week 0, Week 2, Week 8, up to Week 26 ] [ Designated as safety issue: No ]
    TSQM is a questionnaire to be completed by the subjects to determine their satisfaction of the medications for ulcerative colitis including the study drug
Not Provided
Not Provided
 
A 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
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

A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis.

Assess the effect of adalimumab on quality of life as measured by the Short Quality of Life Inflammatory Bowel Disease (SIBDQ), the utilization of health care resources and the costs of care for the ulcerative colitis subjects treated with adalimumab.

Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ulcerative Colitis
Biological: Adalimumab
160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg EOW starting at Week 4
Other Name: ABT-D2E7 Humira
Experimental: Arm 1 - Open label
Adalimumab open label
Intervention: Biological: Adalimumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
455
January 2015
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  1. Subjects with a history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch, or ileostomy for UC or planned bowel surgery.
  2. Subjects received previous treatment with adalimumab or previous participation in an adalimumab clinical study.
  3. Subjects who have previously used infliximab or any anti-TNF agent within 56 days of Baseline (Week 0).
  4. Subjects who have previously used infliximab or any anti-TNF agent and have not clinically responded at any time ("primary non-responder") unless they experienced a treatment limiting reaction
  5. Subjects received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days of Week 0 (Baseline).
Both
18 Years to 75 Years
No
Contact: Debbie Tokimoto 847-938-9415 debbie.tokimoto@abbvie.com
Contact: Sandy Fukumoto, BA 847-938-6826 sandra.m.fukumoto@abbvie.com
Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Greece,   Ireland,   Israel,   Italy,   Netherlands,   Norway,   Poland,   Portugal,   Russian Federation,   Slovakia,   Spain,   Sweden,   Switzerland,   Turkey,   United Kingdom
 
NCT01550965
M13-045, 2011-002411-29
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Roopal Thakkar, MD, MD AbbVie
AbbVie
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP