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 July 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: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
Biological: Adalimumab
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 455
Study Start Date: May 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 - Open label
Adalimumab open label
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550965

Contacts
Contact: Debbie Tokimoto 847-938-9415 debbie.tokimoto@abbvie.com
Contact: Sandy Fukumoto, BA 847-938-6826 sandra.m.fukumoto@abbvie.com

  Show 118 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Roopal Thakkar, MD, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01550965     History of Changes
Other Study ID Numbers: M13-045, 2011-002411-29
Study First Received: March 8, 2012
Last Updated: July 24, 2014
Health Authority: Canada: Health Canada
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Greece: National Organization of Medicines
Ireland: Irish Medicines Board
Israel: Ministry of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Norway: Norwegian Medicines Agency
Portugal: National Pharmacy and Medicines Institute
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Czech Republic: State Institute for Drug Control
Russia: Ministry of Health of the Russian Federation

Keywords provided by AbbVie:
Quality of Life
Costs of Ulcerative Colitis
Health Care Utilization

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014