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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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01550965
First received: March 8, 2012
Last updated: October 28, 2014
Last verified: October 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: April 2015
Estimated Primary Completion Date: April 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

  Hide Study Locations
Locations
Austria
Site Reference ID/Investigator# 97315
Hainburg an der Donau, Austria, 2410
Site Reference ID/Investigator# 66064
Ried im Innkreis, Austria, 4910
Belgium
Site Reference ID/Investigator# 61091
Bonheiden, Belgium, 2820
Site Reference ID/Investigator# 61093
Brussels, Belgium, 1200
Site Reference ID/Investigator# 61089
Gent, Belgium, 9000
Site Reference ID/Investigator# 61092
Ghent, Belgium, 9000
Site Reference ID/Investigator# 61096
Leuven, Belgium, 3000
Site Reference ID/Investigator# 61094
Liege, Belgium, 4000
Site Reference ID/Investigator# 61090
Roeselare, Belgium, 8800
Canada
Site Reference ID/Investigator# 61408
Calgary, Canada, T2N 4Z6
Site Reference ID/Investigator# 64422
Guelph, Canada, N1H 3R3
Site Reference ID/Investigator# 61406
Halifax, Canada, B3H 2Y9
Site Reference ID/Investigator# 61407
Hamilton, Canada, L8S 4K1
Site Reference ID/Investigator# 61405
London, Canada, N6A 5K8
Site Reference ID/Investigator# 61762
Saskatoon, Canada
Site Reference ID/Investigator# 61409
Victoria, Canada, V8T 5G4
Site Reference ID/Investigator# 61403
Winnipeg, Canada, R3A 1R9
Czech Republic
Site Reference ID/Investigator# 105257
Hradec Kralove, Czech Republic, 500 12
Site Reference ID/Investigator# 114195
Prague 10, Czech Republic, 100 34
Site Reference ID/Investigator# 105255
Prague 5, Czech Republic, 15006
Site Reference ID/Investigator# 105256
Prague 7, Czech Republic, 17004
Denmark
Site Reference ID/Investigator# 61117
Aalborg C, Denmark, 9000
Site Reference ID/Investigator# 61119
Hvidovre, Denmark, 2650
France
Site Reference ID/Investigator# 61055
Grenoble Cedex 09, France, 38043
Site Reference ID/Investigator# 61059
Lille Cedex, France, 59037
Site Reference ID/Investigator# 61060
Marseilles Cedex 20, France, 13015
Site Reference ID/Investigator# 61056
Nantes Cedex, France, 44035
Site Reference ID/Investigator# 61057
Reims, France, 51092
Site Reference ID/Investigator# 61063
St. Priest en Jarez, France, 42270
Site Reference ID/Investigator# 63462
Vandoeuvre les Nancy Cedex, France, 54511
Germany
Site Reference ID/Investigator# 61064
Berlin, Germany, 13353
Site Reference ID/Investigator# 64222
Dachau, Germany, 85221
Site Reference ID/Investigator# 61066
Herne, Germany, 44623
Site Reference ID/Investigator# 61065
Minden, Germany, 32423
Site Reference ID/Investigator# 61067
Muenster, Germany, 48159
Greece
Site Reference ID/Investigator# 63983
Athens, Greece, 10676
Site Reference ID/Investigator# 63984
Athens, Greece, 106 76
Site Reference ID/Investigator# 63986
Thessaloniki, Greece, 54642
Ireland
Site Reference ID/Investigator# 65987
Dublin 24, Ireland
Site Reference ID/Investigator# 65988
Dublin 4, Ireland
Site Reference ID/Investigator# 65986
Dublin 7, Ireland
Site Reference ID/Investigator# 65989
Dublin 9, Ireland
Israel
Site Reference ID/Investigator# 64203
Be'er Sheva, Israel, 84101
Site Reference ID/Investigator# 64204
Jerusalem, Israel, 91031
Site Reference ID/Investigator# 64205
Jerusalem, Israel, 9112001
Site Reference ID/Investigator# 64206
Petach Tiqwa, Israel, 49100
Site Reference ID/Investigator# 64202
Tel Hashomer, Israel, 52621
Italy
Site Reference ID/Investigator# 61112
Bologna, Italy, 40138
Site Reference ID/Investigator# 61108
Palermo, Italy, 90146
Site Reference ID/Investigator# 61104
Rome, Italy, 00133
Site Reference ID/Investigator# 61115
Rome, Italy, 00152
Site Reference ID/Investigator# 61111
Rozzano, Italy, 20089
Norway
Site Reference ID/Investigator# 62364
Hamar, Norway, 2318
Site Reference ID/Investigator# 62362
Oslo, Norway, 0407
Poland
Site Reference ID/Investigator# 103920
Lodz, Poland, 90-302
Site Reference ID/Investigator# 103919
Sopot, Poland, 81-756
Site Reference ID/Investigator# 103915
Warsaw, Poland, 02-507
Site Reference ID/Investigator# 103916
Warsaw, Poland, 02-781
Site Reference ID/Investigator# 103918
Warsaw, Poland, 03-580
Portugal
Site Reference ID/Investigator# 61099
Coimbra, Portugal, 3000-075
Site Reference ID/Investigator# 61097
Lisbon, Portugal, 1649-035
Site Reference ID/Investigator# 61102
Lisbon, Portugal, 1169-050
Site Reference ID/Investigator# 61098
Porto, Portugal, 4200-319
Russian Federation
Site Reference ID/Investigator# 121557
Kaluga, Russian Federation, 248007
Site Reference ID/Investigator# 120500
Kazan, Russian Federation, 420012
Site Reference ID/Investigator# 121556
Lipetsk, Russian Federation, 398055
Site Reference ID/Investigator# 120536
Moscow, Russian Federation, 111123
Site Reference ID/Investigator# 120501
Rostov on Don, Russian Federation, 344029
Site Reference ID/Investigator# 121555
Smolensk, Russian Federation, 214018
Site Reference ID/Investigator# 120535
Stavropol, Russian Federation, 355017
Site Reference ID/Investigator# 120517
Ufa, Russian Federation, 450072
Site Reference ID/Investigator# 121616
Volgograd, Russian Federation, 400107
Slovakia
Site Reference ID/Investigator# 109556
Banska Bystrica, Slovakia, 97 401
Site Reference ID/Investigator# 109555
Nitra, Slovakia, 94 901
Site Reference ID/Investigator# 109557
Nove Mesto nad Vahom, Slovakia, 915 01
Site Reference ID/Investigator# 117355
Presov, Slovakia, 08 001
Spain
Site Reference ID/Investigator# 61087
Badalona - Barcelona, Spain, 08916
Site Reference ID/Investigator# 61083
Barcelona, Spain, 08036
Site Reference ID/Investigator# 61086
Barcelona, Spain, 08035
Site Reference ID/Investigator# 61085
Cordoba, Spain, 14004
Site Reference ID/Investigator# 94013
Las Palmas de Gran Canaria, Spain, 35016
Site Reference ID/Investigator# 61082
Madrid, Spain, 28006
Site Reference ID/Investigator# 63988
Madrid, Spain, 28046
Site Reference ID/Investigator# 61088
Santiago de Compostela, Spain, 15706
Site Reference ID/Investigator# 95075
Valencia, Spain, 46026
Sweden
Site Reference ID/Investigator# 61071
Gothenburg, Sweden, 416 85
Site Reference ID/Investigator# 61072
Lund, Sweden, 22185
Site Reference ID/Investigator# 65583
Skovde, Sweden, 541 85
Switzerland
Site Reference ID/Investigator# 66183
St. Gallen, Switzerland, 9007
Turkey
Site Reference ID/Investigator# 63282
Ankara, Turkey, 06100
Site Reference ID/Investigator# 63283
Istanbul, Turkey, 34093
Site Reference ID/Investigator# 63285
Istanbul, Turkey, 34098
Site Reference ID/Investigator# 63284
Izmir, Turkey, 35360
United Kingdom
Site Reference ID/Investigator# 100375
Basingstoke, United Kingdom, RG24 9NA
Site Reference ID/Investigator# 62367
Gloucester, United Kingdom, GL1 3NN
Site Reference ID/Investigator# 99535
Liverpool, United Kingdom, L7 8XP
Site Reference ID/Investigator# 106915
London, United Kingdom, SE1 7EH
Site Reference ID/Investigator# 62567
London, United Kingdom, NW1 2PG
Site Reference ID/Investigator# 61046
Oxford, United Kingdom, OX3 9DU
Site Reference ID/Investigator# 62568
Southampton, United Kingdom, SO16 6YD
Site Reference ID/Investigator# 62571
Winchester, United Kingdom, SO22 5DG
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: October 28, 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 November 27, 2014