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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00573794
First received: December 12, 2007
Last updated: October 8, 2014
Last verified: October 2014
  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:


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; Week 292 Week 340 and Week 388 ] [ Designated as safety issue: No ]
  • Change from Baseline in Partial Mayo Scores [ Time Frame: Week 48, Week 96, Week 144, Week 192; Week 240; Week 292 Week 340 and Week 388 ] [ 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; Week 292 Week 340 and Week 388 ] [ 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; Week 292; Week 340 and Week 388 ] [ 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: Throughout course of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: November 2007
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: May 2016 (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 Name: 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
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: 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# 7318
Lutherville, Maryland, United States, 21093
Site Reference ID/Investigator# 6769
Silver Spring, Maryland, United States, 20901
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, 64131
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# 15541
Germantown, Tennessee, United States, 38138
Site Reference ID/Investigator# 6871
Germantown, Tennessee, United States, 38138
Site Reference ID/Investigator# 17421
Nashville, Tennessee, United States, 37205
Site Reference ID/Investigator# 13341
Nashville, Tennessee, United States, 37212
Site Reference ID/Investigator# 6767
Nashville, Tennessee, United States, 37203
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# 19981
Vienna, Austria, 1030
Site Reference ID/Investigator# 8385
Vienna, Austria, 1090
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, 625 00
Site Reference ID/Investigator# 19002
Ceske Budejovice, Czech Republic, 37001
Site Reference ID/Investigator# 14164
Hradec Kralove, Czech Republic, 500 12
Site Reference ID/Investigator# 19261
Olomouc, Czech Republic, 775 20
Site Reference ID/Investigator# 11721
Olomouc, Czech Republic, 77520
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, Germany, 07747
Site Reference ID/Investigator# 12961
Kiel, Germany, 24105
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, 93042
Hungary
Site Reference ID/Investigator# 17201
Budapest, Hungary, H-1125
Site Reference ID/Investigator# 10721
Budapest, Hungary, H-1135
Site Reference ID/Investigator# 67723
Budapest, Hungary, 1136
Site Reference ID/Investigator# 17188
Budapest, Hungary, H-1076
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
Petach Tiqwa, 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# 18142
Warsaw, Poland, 02-781
Site Reference ID/Investigator# 19687
Warsaw, Poland, 02-507
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
Bratislava 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:
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: October 8, 2014
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
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014