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.
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
  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: January 2015
Estimated Primary Completion Date: June 2014 (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
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

  Hide Study Locations
Locations
Austria
Site Reference ID/Investigator# 97315 Recruiting
Hainburg an der Donau, Austria, 2410
Principal Investigator: Site Reference ID/Investigator# 97315         
Site Reference ID/Investigator# 66064 Completed
Ried im Innkreis, Austria, 4910
Site Reference ID/Investigator# 66188 Withdrawn
St. Poelten, Austria, 3100
Belgium
Site Reference ID/Investigator# 61091 Recruiting
Bonheiden, Belgium, 2820
Principal Investigator: Site Reference ID/Investigator# 61091         
Site Reference ID/Investigator# 61093 Recruiting
Brussels, Belgium, 1200
Principal Investigator: Site Reference ID/Investigator# 61093         
Site Reference ID/Investigator# 61089 Recruiting
Ghent, Belgium, 9000
Principal Investigator: Site Reference ID/Investigator# 61089         
Site Reference ID/Investigator# 61092 Recruiting
Ghent, Belgium, 9000
Principal Investigator: Site Reference ID/Investigator# 61092         
Site Reference ID/Investigator# 63843 Withdrawn
Kortrijk, Belgium, 8500
Site Reference ID/Investigator# 61096 Recruiting
Leuven, Belgium, 3000
Principal Investigator: Site Reference ID/Investigator# 61096         
Site Reference ID/Investigator# 61094 Recruiting
Liege, Belgium, 4000
Principal Investigator: Site Reference ID/Investigator# 61094         
Site Reference ID/Investigator# 61090 Recruiting
Roeselare, Belgium, 8800
Principal Investigator: Site Reference ID/Investigator# 61090         
Canada
Site Reference ID/Investigator# 61408 Recruiting
Calgary, Canada, T2N 4Z6
Principal Investigator: Site Reference ID/Investigator# 61408         
Site Reference ID/Investigator# 64422 Recruiting
Guelph, Canada, N1H 3R3
Principal Investigator: Site Reference ID/Investigator# 64422         
Site Reference ID/Investigator# 61406 Recruiting
Halifax, Canada, B3H 2Y9
Principal Investigator: Site Reference ID/Investigator# 61406         
Site Reference ID/Investigator# 61407 Recruiting
Hamilton, Canada, L8S 4K1
Principal Investigator: Site Reference ID/Investigator# 61407         
Site Reference ID/Investigator# 61405 Recruiting
London, Canada, N6A 5K8
Principal Investigator: Site Reference ID/Investigator# 61405         
Site Reference ID/Investigator# 61762 Recruiting
Saskatoon, Canada
Principal Investigator: Site Reference ID/Investigator# 61762         
Site Reference ID/Investigator# 61409 Recruiting
Victoria, Canada, V8T 5G4
Principal Investigator: Site Reference ID/Investigator# 61409         
Site Reference ID/Investigator# 61403 Recruiting
Winnipeg, Canada, R3A 1R9
Principal Investigator: Site Reference ID/Investigator# 61403         
Czech Republic
Site Reference ID/Investigator# 105257 Recruiting
Hradec Kralove, Czech Republic, 500 12
Principal Investigator: Site Reference ID/Investigator# 105257         
Site Reference ID/Investigator# 114195 Recruiting
Prague 10, Czech Republic, 100 34
Principal Investigator: Site Reference ID/Investigator# 114195         
Site Reference ID/Investigator# 105255 Not yet recruiting
Prague 5, Czech Republic, 15006
Principal Investigator: Site Reference ID/Investigator# 105255         
Site Reference ID/Investigator# 105256 Recruiting
Prague 7, Czech Republic, 17004
Principal Investigator: Site Reference ID/Investigator# 105256         
Denmark
Site Reference ID/Investigator# 61117 Recruiting
Aalborg C, Denmark, 9000
Principal Investigator: Site Reference ID/Investigator# 61117         
Site Reference ID/Investigator# 61118 Withdrawn
Copenhagen, Denmark, 2100
Site Reference ID/Investigator# 61119 Recruiting
Hvidovre, Denmark, 2650
Principal Investigator: Site Reference ID/Investigator# 61119         
Finland
Site Reference ID/Investigator# 63292 Withdrawn
Lahti, Finland, 15850
France
Site Reference ID/Investigator# 61055 Recruiting
Grenoble Cedex 09, France, 38043
Principal Investigator: Site Reference ID/Investigator# 61055         
Site Reference ID/Investigator# 61059 Recruiting
Lille Cedex, France, 59037
Principal Investigator: Site Reference ID/Investigator# 61059         
Site Reference ID/Investigator# 61060 Not yet recruiting
Marseilles Cedex 20, France, 13015
Principal Investigator: Site Reference ID/Investigator# 61060         
Site Reference ID/Investigator# 61056 Recruiting
Nantes Cedex, France, 44035
Principal Investigator: Site Reference ID/Investigator# 61056         
Site Reference ID/Investigator# 63463 Withdrawn
Pessac Cedex, France, 33600
Site Reference ID/Investigator# 61057 Recruiting
Reims, France, 51092
Principal Investigator: Site Reference ID/Investigator# 61057         
Site Reference ID/Investigator# 61063 Recruiting
St. Priest en Jarez, France, 42270
Principal Investigator: Site Reference ID/Investigator# 61063         
Site Reference ID/Investigator# 63462 Recruiting
Vandoeuvre les Nancy Cedex, France, 54511
Principal Investigator: Site Reference ID/Investigator# 63462         
Germany
Site Reference ID/Investigator# 61064 Recruiting
Berlin, Germany, 13353
Principal Investigator: Site Reference ID/Investigator# 61064         
Site Reference ID/Investigator# 64222 Recruiting
Dachau, Germany, 85221
Principal Investigator: Site Reference ID/Investigator# 64222         
Site Reference ID/Investigator# 61069 Withdrawn
Hamburg, Germany, 22559
Site Reference ID/Investigator# 61066 Recruiting
Herne, Germany, 44623
Principal Investigator: Site Reference ID/Investigator# 61066         
Site Reference ID/Investigator# 61065 Recruiting
Minden, Germany, 32423
Principal Investigator: Site Reference ID/Investigator# 61065         
Site Reference ID/Investigator# 61067 Recruiting
Muenster, Germany, 48159
Principal Investigator: Site Reference ID/Investigator# 61067         
Greece
Site Reference ID/Investigator# 63983 Recruiting
Athens, Greece, 10676
Principal Investigator: Site Reference ID/Investigator# 63983         
Site Reference ID/Investigator# 63984 Recruiting
Athens, Greece, 106 76
Principal Investigator: Site Reference ID/Investigator# 63984         
Site Reference ID/Investigator# 63985 Recruiting
Ioannina, Greece, 45500
Principal Investigator: Site Reference ID/Investigator# 63985         
Site Reference ID/Investigator# 63986 Recruiting
Thessaloniki, Greece, 54642
Principal Investigator: Site Reference ID/Investigator# 63986         
Ireland
Site Reference ID/Investigator# 65987 Recruiting
Dublin 24, Ireland
Principal Investigator: Site Reference ID/Investigator# 65987         
Site Reference ID/Investigator# 65988 Recruiting
Dublin 4, Ireland
Principal Investigator: Site Reference ID/Investigator# 65988         
Site Reference ID/Investigator# 65986 Recruiting
Dublin 7, Ireland
Principal Investigator: Site Reference ID/Investigator# 65986         
Site Reference ID/Investigator# 65989 Recruiting
Dublin 9, Ireland
Principal Investigator: Site Reference ID/Investigator# 65989         
Israel
Site Reference ID/Investigator# 64203 Recruiting
Be'er Sheva, Israel, 84101
Principal Investigator: Site Reference ID/Investigator# 64203         
Site Reference ID/Investigator# 64204 Recruiting
Jerusalem, Israel, 91031
Principal Investigator: Site Reference ID/Investigator# 64204         
Site Reference ID/Investigator# 64205 Recruiting
Jerusalem, Israel, 9112001
Principal Investigator: Site Reference ID/Investigator# 64205         
Site Reference ID/Investigator# 64206 Recruiting
Petach Tiqwa, Israel, 49100
Principal Investigator: Site Reference ID/Investigator# 64206         
Site Reference ID/Investigator# 64202 Recruiting
Tel Hashomer, Israel, 52621
Principal Investigator: Site Reference ID/Investigator# 64202         
Italy
Site Reference ID/Investigator# 61112 Recruiting
Bologna, Italy, 40138
Principal Investigator: Site Reference ID/Investigator# 61112         
Site Reference ID/Investigator# 61108 Recruiting
Palermo, Italy, 90146
Principal Investigator: Site Reference ID/Investigator# 61108         
Site Reference ID/Investigator# 61104 Recruiting
Rome, Italy, 00133
Principal Investigator: Site Reference ID/Investigator# 61104         
Site Reference ID/Investigator# 61115 Recruiting
Rome, Italy, 00152
Principal Investigator: Site Reference ID/Investigator# 61115         
Site Reference ID/Investigator# 61111 Recruiting
Rozzano, Italy, 20089
Principal Investigator: Site Reference ID/Investigator# 61111         
Netherlands
Site Reference ID/Investigator# 61122 Withdrawn
Amersfoort, Netherlands, 3818 ES
Site Reference ID/Investigator# 61121 Withdrawn
Amsterdam, Netherlands, 1105 AZ
Site Reference ID/Investigator# 61124 Withdrawn
Amsterdam, Netherlands, 1091 AC
Site Reference ID/Investigator# 61126 Withdrawn
Arnem, Netherlands, 6815 AD
Site Reference ID/Investigator# 61120 Withdrawn
Leiden, Netherlands, 2333 ZA
Norway
Site Reference ID/Investigator# 62364 Recruiting
Hamar, Norway, 2318
Principal Investigator: Site Reference ID/Investigator# 62364         
Site Reference ID/Investigator# 62362 Recruiting
Oslo, Norway, 0407
Principal Investigator: Site Reference ID/Investigator# 62362         
Poland
Site Reference ID/Investigator# 103920 Recruiting
Lodz, Poland, 90-302
Principal Investigator: Site Reference ID/Investigator# 103920         
Site Reference ID/Investigator# 103919 Recruiting
Sopot, Poland, 81-756
Principal Investigator: Site Reference ID/Investigator# 103919         
Site Reference ID/Investigator# 103915 Recruiting
Warsaw, Poland, 02-507
Principal Investigator: Site Reference ID/Investigator# 103915         
Site Reference ID/Investigator# 103918 Recruiting
Warsaw, Poland, 03-580
Principal Investigator: Site Reference ID/Investigator# 103918         
Portugal
Site Reference ID/Investigator# 61099 Recruiting
Coimbra, Portugal, 3000-075
Principal Investigator: Site Reference ID/Investigator# 61099         
Site Reference ID/Investigator# 61100 Recruiting
Faro, Portugal, 8000-386
Principal Investigator: Site Reference ID/Investigator# 61100         
Site Reference ID/Investigator# 61102 Recruiting
Lisbon, Portugal, 1150-314
Principal Investigator: Site Reference ID/Investigator# 61102         
Site Reference ID/Investigator# 61101 Withdrawn
Lisbon, Portugal, 1349-019
Site Reference ID/Investigator# 61097 Recruiting
Lisbon, Portugal, 1649-035
Principal Investigator: Site Reference ID/Investigator# 61097         
Site Reference ID/Investigator# 61098 Recruiting
Porto, Portugal, 4200-319
Principal Investigator: Site Reference ID/Investigator# 61098         
Russian Federation
Site Reference ID/Investigator# 121557 Not yet recruiting
Kaluga, Russian Federation, 248007
Principal Investigator: Site Reference ID/Investigator# 121557         
Site Reference ID/Investigator# 120500 Recruiting
Kazan, Russian Federation, 420012
Principal Investigator: Site Reference ID/Investigator# 120500         
Site Reference ID/Investigator# 121556 Recruiting
Lipetsk, Russian Federation, 398055
Principal Investigator: Site Reference ID/Investigator# 121556         
Site Reference ID/Investigator# 120536 Not yet recruiting
Moscow, Russian Federation, 111123
Principal Investigator: Site Reference ID/Investigator# 120536         
Site Reference ID/Investigator# 120501 Recruiting
Rostov on Don, Russian Federation, 344029
Principal Investigator: Site Reference ID/Investigator# 120501         
Site Reference ID/Investigator# 121555 Not yet recruiting
Smolensk, Russian Federation, 214018
Principal Investigator: Site Reference ID/Investigator# 121555         
Site Reference ID/Investigator# 120535 Recruiting
Stavropol, Russian Federation, 355017
Principal Investigator: Site Reference ID/Investigator# 120535         
Site Reference ID/Investigator# 121616 Not yet recruiting
Volgograd, Russian Federation, 400107
Principal Investigator: Site Reference ID/Investigator# 121616         
Slovakia
Site Reference ID/Investigator# 109556 Recruiting
Banska Bystrica, Slovakia, 97 401
Principal Investigator: Site Reference ID/Investigator# 109556         
Site Reference ID/Investigator# 109555 Recruiting
Nitra, Slovakia, 94 901
Principal Investigator: Site Reference ID/Investigator# 109555         
Site Reference ID/Investigator# 109557 Recruiting
Nove Mesto nad Vahom, Slovakia, 915 01
Principal Investigator: Site Reference ID/Investigator# 109557         
Site Reference ID/Investigator# 117355 Recruiting
Presov, Slovakia, 08 001
Principal Investigator: Site Reference ID/Investigator# 117355         
Spain
Site Reference ID/Investigator# 61087 Recruiting
Badalona - Barcelona, Spain, 08916
Principal Investigator: Site Reference ID/Investigator# 61087         
Site Reference ID/Investigator# 61083 Recruiting
Barcelona, Spain, 08036
Principal Investigator: Site Reference ID/Investigator# 61083         
Site Reference ID/Investigator# 61086 Recruiting
Barcelona, Spain, 08035
Principal Investigator: Site Reference ID/Investigator# 61086         
Site Reference ID/Investigator# 61085 Recruiting
Cordoba, Spain, 14004
Principal Investigator: Site Reference ID/Investigator# 61085         
Site Reference ID/Investigator# 94013 Recruiting
Las Palmas de Gran Canaria, Spain, 35016
Principal Investigator: Site Reference ID/Investigator# 94013         
Site Reference ID/Investigator# 63988 Recruiting
Madrid, Spain, 28046
Principal Investigator: Site Reference ID/Investigator# 63988         
Site Reference ID/Investigator# 61082 Recruiting
Madrid, Spain, 28006
Principal Investigator: Site Reference ID/Investigator# 61082         
Site Reference ID/Investigator# 61088 Recruiting
Santiago de Compostela, Spain, 15706
Principal Investigator: Site Reference ID/Investigator# 61088         
Site Reference ID/Investigator# 95075 Recruiting
Valencia, Spain, 46026
Principal Investigator: Site Reference ID/Investigator# 95075         
Sweden
Site Reference ID/Investigator# 61071 Recruiting
Gothenburg, Sweden, 416 85
Principal Investigator: Site Reference ID/Investigator# 61071         
Site Reference ID/Investigator# 61073 Withdrawn
Linkoping, Sweden, 581 85
Site Reference ID/Investigator# 61072 Recruiting
Lund, Sweden, 22185
Principal Investigator: Site Reference ID/Investigator# 61072         
Site Reference ID/Investigator# 65583 Recruiting
Skovde, Sweden, 541 85
Principal Investigator: Site Reference ID/Investigator# 65583         
Site Reference ID/Investigator# 65586 Withdrawn
Stockholm, Sweden, 11281
Switzerland
Site Reference ID/Investigator# 66184 Withdrawn
Bern, Switzerland, 3010
Site Reference ID/Investigator# 66183 Recruiting
St. Gallen, Switzerland, 9007
Principal Investigator: Site Reference ID/Investigator# 66183         
Turkey
Site Reference ID/Investigator# 63282 Recruiting
Ankara, Turkey, 06100
Principal Investigator: Site Reference ID/Investigator# 63282         
Site Reference ID/Investigator# 63283 Recruiting
Istanbul, Turkey, 34093
Principal Investigator: Site Reference ID/Investigator# 63283         
Site Reference ID/Investigator# 63285 Recruiting
Istanbul, Turkey, 34098
Principal Investigator: Site Reference ID/Investigator# 63285         
Site Reference ID/Investigator# 63284 Recruiting
Izmir, Turkey, 35360
Principal Investigator: Site Reference ID/Investigator# 63284         
United Kingdom
Site Reference ID/Investigator# 100375 Recruiting
Basingstoke, United Kingdom, RG24 9NA
Principal Investigator: Site Reference ID/Investigator# 100375         
Site Reference ID/Investigator# 62367 Recruiting
Gloucester, United Kingdom, GL1 3NN
Principal Investigator: Site Reference ID/Investigator# 62367         
Site Reference ID/Investigator# 99535 Recruiting
Liverpool, United Kingdom, L7 8XP
Principal Investigator: Site Reference ID/Investigator# 99535         
Site Reference ID/Investigator# 106915 Recruiting
London, United Kingdom, SE1 7EH
Principal Investigator: Site Reference ID/Investigator# 106915         
Site Reference ID/Investigator# 62567 Recruiting
London, United Kingdom, NW1 2PG
Principal Investigator: Site Reference ID/Investigator# 62567         
Site Reference ID/Investigator# 61046 Recruiting
Oxford, United Kingdom, OX3 9DU
Principal Investigator: Site Reference ID/Investigator# 61046         
Site Reference ID/Investigator# 62568 Recruiting
Southampton, United Kingdom, SO16 6YD
Principal Investigator: Site Reference ID/Investigator# 62568         
Site Reference ID/Investigator# 62571 Recruiting
Winchester, United Kingdom, SO22 5DG
Principal Investigator: Site Reference ID/Investigator# 62571         
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: April 8, 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
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Pathologic Processes
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 23, 2014