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Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00573794
First received: December 12, 2007
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  Purpose

To assess the long-term safety and maintenance of response of adalimumab in subjects with ulcerative colitis


Condition Intervention Phase
Ulcerative Colitis
 Biological: adalimumab
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Change from Baseline in Mayo Scores [ Time Frame: Week 48, Week 96, Week 144, Week 192; Week 240 and Week 292 ] [ Designated as safety issue: No ]
  • Change from Baseline in Partial Mayo Scores [ Time Frame: Week 48, Week 96, Week 144, Week 192; Week 240 and Week 292 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in IBDQ & SF-36 [ Time Frame: Week 48, Week 96, Week 144, Week 192; Week 240 and Week 292 ] [ Designated as safety issue: No ]
  • Change from Baseline in Work Productivity and Activity Impairment Questionnaire [ Time Frame: Week 48, Week 96, Week 144, Week 192; Week 240 and Week 292 ] [ Designated as safety issue: No ]
  • AEs, Laboratory data, physical exams, and vital signs [ Time Frame: Throughout course of the study ] [ Designated as safety issue: No ]
  • Cumulative number of unscheduled outpatient visits [ Time Frame: Week 48, Week 96, Week 144, Week 192; Week 240 and Week 292 ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: November 2007
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 40 mg EOW or 40 mg weekly Biological: adalimumab
Prefilled syringes 40 mg EOW subcutaneous and prefilled syringes 40 mg weekly subcutaneous
Other Names:
  • ABT-D2E7
  • Humira

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject must have successfully enrolled and completed either the M06-826 study or the M06-827 study
  • Subject is judged to be in generally good health as determined by the principal investigator

Exclusion Criteria:

  • Subject has not responded to weekly adalimumab therapy in M06-826 or M06-827
  • Subject considered by the investigator, for any reason, to be an unsuitable candidate
  • Female subject who is pregnant or breast-feeding or considering becoming pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573794

  Hide Study Locations
Locations
United States, Alabama
Site Reference ID/Investigator# 6684
Birmingham, Alabama, United States, 35209
Site Reference ID/Investigator# 9844
Mobile, Alabama, United States, 36617
United States, Arkansas
Site Reference ID/Investigator# 9741
Fayetteville, Arkansas, United States, 72703
United States, California
Site Reference ID/Investigator# 11502
Anaheim, California, United States, 92801
Site Reference ID/Investigator# 17861
Orange, California, United States, 92868
Site Reference ID/Investigator# 11303
San Diego, California, United States, 92123
United States, Colorado
Site Reference ID/Investigator# 6942
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Site Reference ID/Investigator# 7557
Bridgeport, Connecticut, United States, 06606
Site Reference ID/Investigator# 9841
Hamden, Connecticut, United States, 06518
United States, Florida
Site Reference ID/Investigator# 10002
Gainesville, Florida, United States, 32610
Site Reference ID/Investigator# 13261
Hollywood, Florida, United States, 33021
Site Reference ID/Investigator# 24082
Naples, Florida, United States, 34102
Site Reference ID/Investigator# 7720
South Miami, Florida, United States, 33143
Site Reference ID/Investigator# 6877
Winter Park, Florida, United States, 32789
United States, Georgia
Site Reference ID/Investigator# 6736
Atlanta, Georgia, United States, 30342
Site Reference ID/Investigator# 19624
Macon, Georgia, United States, 31201
United States, Illinois
Site Reference ID/Investigator# 11321
Moline, Illinois, United States, 61265
United States, Kansas
Site Reference ID/Investigator# 21482
Topeka, Kansas, United States, 66606
United States, Maryland
Site Reference ID/Investigator# 11702
Annapolis, Maryland, United States, 21401
Site Reference ID/Investigator# 12421
Annapolis, Maryland, United States, 21401
Site Reference ID/Investigator# 7135
Chevy Chase, Maryland, United States, 20815
Site Reference ID/Investigator# 6769
Silver Spring, Maryland, United States, 20901
Site Reference ID/Investigator# 7318
Towson, Maryland, United States, 21286
United States, Michigan
Site Reference ID/Investigator# 19081
Troy, Michigan, United States, 48098
United States, Missouri
Site Reference ID/Investigator# 6734
Kansas City, Missouri, United States, 64134
Site Reference ID/Investigator# 7719
Mexico, Missouri, United States, 65265-3726
Site Reference ID/Investigator# 9161
St. Louis, Missouri, United States, 63128
United States, Nebraska
Site Reference ID/Investigator# 6914
Lincoln, Nebraska, United States, 68503
United States, New Jersey
Site Reference ID/Investigator# 9222
Cedar Knolls, New Jersey, United States, 07927
United States, New York
Site Reference ID/Investigator# 7136
Great Neck, New York, United States, 11021
Site Reference ID/Investigator# 15561
New York, New York, United States, 10029
United States, North Carolina
Site Reference ID/Investigator# 6735
Charlotte, North Carolina, United States, 28211
Site Reference ID/Investigator# 7889
Charlotte, North Carolina, United States, 28207
Site Reference ID/Investigator# 6879
Jacksonville, North Carolina, United States, 28546
Site Reference ID/Investigator# 6943
Raleigh, North Carolina, United States, 27612
United States, Ohio
Site Reference ID/Investigator# 19625
Cincinnati, Ohio, United States, 45219
United States, South Carolina
Site Reference ID/Investigator# 7717
Columbia, South Carolina, United States, 29204
United States, Tennessee
Site Reference ID/Investigator# 6871
Germantown, Tennessee, United States, 38138
Site Reference ID/Investigator# 15541
Germantown, Tennessee, United States, 38138
Site Reference ID/Investigator# 6767
Nashville, Tennessee, United States, 37203
Site Reference ID/Investigator# 13341
Nashville, Tennessee, United States, 37212
Site Reference ID/Investigator# 17421
Nashville, Tennessee, United States, 37205
United States, Utah
Site Reference ID/Investigator# 18321
Ogden, Utah, United States, 84405
United States, Washington
Site Reference ID/Investigator# 9843
Bellevue, Washington, United States, 98004
Site Reference ID/Investigator# 24002
Spokane, Washington, United States, 99202
United States, Wisconsin
Site Reference ID/Investigator# 6922
Milwaukee, Wisconsin, United States, 53215
Site Reference ID/Investigator# 7718
West Bend, Wisconsin, United States, 53095
Australia
Site Reference ID/Investigator# 22507
Bedford Park, Australia, 5042
Site Reference ID/Investigator# 22511
Fremantle, Australia, 6160
Site Reference ID/Investigator# 22509
Herston, Australia, 4029
Site Reference ID/Investigator# 22510
Malvern, Australia, 3144
Austria
Site Reference ID/Investigator# 12981
Innsbruck, Austria, 6020
Site Reference ID/Investigator# 8381
Salzburg, Austria, A-5020
Site Reference ID/Investigator# 8385
Vienna, Austria, 1090
Site Reference ID/Investigator# 19981
Vienna, Austria, 1030
Belgium
Site Reference ID/Investigator# 11861
Bonheiden, Belgium, 2820
Site Reference ID/Investigator# 14162
Brussels, Belgium, 1200
Site Reference ID/Investigator# 11223
Ghent, Belgium, 9000
Site Reference ID/Investigator# 10601
Leuven, Belgium, 3000
Site Reference ID/Investigator# 14163
Liege, Belgium, 4000
Site Reference ID/Investigator# 11782
Roeselare, Belgium, 8800
Canada
Site Reference ID/Investigator# 13962
Calgary, Canada, T2N 4Z6
Site Reference ID/Investigator# 10481
Edmonton, Canada, T6G 2X8
Site Reference ID/Investigator# 15281
Hamilton, Canada, L8S 4K1
Site Reference ID/Investigator# 24382
Kelowna, Canada, V1Y 1Z9
Site Reference ID/Investigator# 9903
Montreal, Canada, H3G 1A4
Site Reference ID/Investigator# 15241
Montreal, Canada, H3T 1E2
Site Reference ID/Investigator# 19082
Quebec City, Canada, G1S 4L8
Site Reference ID/Investigator# 27661
Sudbury, Canada, P3E 2N8
Site Reference ID/Investigator# 27828
Toronto, Canada, M5G 1X5
Site Reference ID/Investigator# 8377
Vancouver, Canada, V6Z-2K5
Site Reference ID/Investigator# 8388
Vaughan, Canada, L4L 4Y7
Site Reference ID/Investigator# 17368
Victoria, Canada, V8T 5G4
Site Reference ID/Investigator# 9221
Winnipeg, Canada, R3A 1R9
Czech Republic
Site Reference ID/Investigator# 19921
Brno, Czech Republic, 62500
Site Reference ID/Investigator# 19002
Ceske Budejovice, Czech Republic, 370 87
Site Reference ID/Investigator# 14164
Hradec Kralove 12, Czech Republic, 500 12
Site Reference ID/Investigator# 11721
Olomouc, Czech Republic, 77520
Site Reference ID/Investigator# 19261
Olomouc, Czech Republic, 775 20
Site Reference ID/Investigator# 19461
Ostrava, Czech Republic, 708 52
Site Reference ID/Investigator# 10602
Prague 1, Czech Republic, 118 33
Site Reference ID/Investigator# 19722
Prague 4, Czech Republic, 140 21
Site Reference ID/Investigator# 19721
Prague 5, Czech Republic, 15006
Site Reference ID/Investigator# 11681
Prague 7, Czech Republic, 17004
France
Site Reference ID/Investigator# 14001
Clichy, France, 92110
Site Reference ID/Investigator# 15041
Lille Cedex, France, 59037
Site Reference ID/Investigator# 19984
Pessac Cedex, France, 33600
Site Reference ID/Investigator# 14961
Toulouse, France, 31059
Germany
Site Reference ID/Investigator# 11901
Berlin, Germany, 13353
Site Reference ID/Investigator# 19988
Essen, Germany, D-45239
Site Reference ID/Investigator# 21521
Hamburg, Germany, 22559
Site Reference ID/Investigator# 19985
Hamburg, Germany, 20148
Site Reference ID/Investigator# 11221
Jena Lebeda Ost, Germany, 07747
Site Reference ID/Investigator# 12961
Kiel, Germany, 24100
Site Reference ID/Investigator# 19987
Magdeburg, Germany, 39120
Site Reference ID/Investigator# 21524
Minden, Germany, 32423
Site Reference ID/Investigator# 21522
Muenster, Germany, 48159
Site Reference ID/Investigator# 17194
Munich, Germany, 81377
Site Reference ID/Investigator# 21501
Regensburg, Germany, 93053
Hungary
Site Reference ID/Investigator# 17188
Budapest, Hungary, H-1076
Site Reference ID/Investigator# 10721
Budapest, Hungary, H-1135
Site Reference ID/Investigator# 17201
Budapest, Hungary, H-1125
Site Reference ID/Investigator# 67723
Budapest, Hungary, 1136
Site Reference ID/Investigator# 25662
Debrecen, Hungary, 4032
Site Reference ID/Investigator# 12101
Gyor, Hungary, H-9024
Site Reference ID/Investigator# 25663
Gyula, Hungary, 5700
Site Reference ID/Investigator# 10305
Miskolc, Hungary, H-3526
Israel
Site Reference ID/Investigator# 26622
Kfar Saba, Israel, 44281
Site Reference ID/Investigator# 27302
Petah Tikva, Israel, 49100
Italy
Site Reference ID/Investigator# 15063
Bologna, Italy, 40138
Site Reference ID/Investigator# 19989
Milan, Italy, 20157
Site Reference ID/Investigator# 13463
Rome, Italy, 00133
Netherlands
Site Reference ID/Investigator# 18182
Eindhoven, Netherlands, 5623 EJ
Site Reference ID/Investigator# 24562
Leiden, Netherlands, 2333 ZA
New Zealand
Site Reference ID/Investigator# 22515
Auckland, New Zealand, 0620
Poland
Site Reference ID/Investigator# 18561
Lodz, Poland, 90-153
Site Reference ID/Investigator# 19993
Sopot, Poland, 81-756
Site Reference ID/Investigator# 19687
Warsaw, Poland, 02-507
Site Reference ID/Investigator# 18142
Warsaw, Poland, 02 781
Puerto Rico
Site Reference ID/Investigator# 6644
Ponce, Puerto Rico, 00717
Site Reference ID/Investigator# 9822
San Juan, Puerto Rico, 00935
Slovakia
Site Reference ID/Investigator# 11327
Banska Bystrica, Slovakia, 97 401
Site Reference ID/Investigator# 11362
Bratislava, Slovakia, 833 05
Site Reference ID/Investigator# 11328
Bratislave III, Slovakia, 83104
Site Reference ID/Investigator# 11382
Nitra, Slovakia, 94 901
Site Reference ID/Investigator# 19996
Presov, Slovakia, 08001
Site Reference ID/Investigator# 19997
Trencin, Slovakia, 91101
Site Reference ID/Investigator# 11322
Trnava, Slovakia, 917 01
Spain
Site Reference ID/Investigator# 10562
Barcelona, Spain, 08036
Sweden
Site Reference ID/Investigator# 20000
Linkoping, Sweden, 581 85
Site Reference ID/Investigator# 19999
Lund, Sweden, 22185
Switzerland
Site Reference ID/Investigator# 21623
Basel, Switzerland, 4031
Site Reference ID/Investigator# 21523
Bern, Switzerland, 3010
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Andreas Lazar, MD AbbVie
  More Information

Additional Information:
This Clinical Study maybe evaluating a usage that is not currently FDA-approved. Please see US prescribing information for approved uses.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00573794     History of Changes
Other Study ID Numbers: M10-223, 2007-004157-28
Study First Received: December 12, 2007
Last Updated: April 8, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria : Federal Ministry for Labour, Health, and Social Affairs
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
New Zealand: Medsafe
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Switzerland: Swissmedic
United States: Food and Drug Administration

Keywords provided by AbbVie:
Ulcerative Colitis

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

ClinicalTrials.gov processed this record on May 16, 2013