A Long-Term Registry of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00524537
First received: August 31, 2007
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

The primary objective of this Registry study is to evaluate the long-term safety and effectiveness of adalimumab in CD subjects who are treated as recommended in the product label.


Condition Intervention
Crohn's Disease
Biological: adalimumab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • The primary objective of this Registry study is to evaluate the long-term safety of adalimumab in CD subjects who are treated as recommended in the local product label. [ Time Frame: Up to Six Years of Treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary objective is to evaluate long-term effectiveness of adalimumab in CD subjects who are treated as recommended in the local product label. [ Time Frame: Up to Six years of Treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: September 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Adalimumab (Humira) Treatment
Patients who are prescribed and treated with Adalimumab (Humira)
Biological: adalimumab
Physicians prescribe adalimumab as per the current label
Other Name: ABT-D2E7 Humira®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Crohn's patients who have been prescribed adalimumab according to the local label.

Criteria

Inclusion Criteria:

  • Subjects who are newly prescribed HUMIRA® (adalimumab) therapy (have never been treated with adalimumab) or who are participants in Abbott sponsored investigational CD trials, are currently receiving adalimumab and for whom the treating physician has made the decision to continue with adalimumab therapy beyond the duration of the investigational trial.
  • Subjects who were participants in Abbott sponsored investigational Crohn's disease trials, who have not had dose interruptions since the last dose of study drug, where the Investigator can provide source documentation of dosing information.
  • Subjects who are currently receiving adalimumab, as per the local approved label, who have not had dose interruptions since the induction dose of adalimumab where the Investigator can provide source documentation of dosing information.
  • Subjects willing to consent to data being collected and provided to Abbott.
  • Subjects capable of and willing to give written informed consent and to comply with the requirements of the Registry study protocol.

Exclusion Criteria:

  • Subjects should not be enrolled if they cannot be treated in accordance with the local product label.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00524537

  Hide Study Locations
Locations
United States, Alabama
Site Reference ID/Investigator# 11623
Birmingham, Alabama, United States, 35294
Site Reference ID/Investigator# 6669
Birmingham, Alabama, United States, 35209
Site Reference ID/Investigator# 16746
Montgomery, Alabama, United States, 36116
United States, California
Site Reference ID/Investigator# 21002
Lakewood, California, United States, 90712
Site Reference ID/Investigator# 9276
Los Angeles, California, United States, 90048
Site Reference ID/Investigator# 21003
Monterey, California, United States, 93940
Site Reference ID/Investigator# 8265
Orange, California, United States, 92868
Site Reference ID/Investigator# 19602
San Carlos, California, United States, 94070
Site Reference ID/Investigator# 6857
San Diego, California, United States, 92103
United States, Colorado
Site Reference ID/Investigator# 20542
Lafayette, Colorado, United States, 80026
Site Reference ID/Investigator# 20541
Littleton, Colorado, United States, 80120
Site Reference ID/Investigator# 18927
Lone Tree, Colorado, United States, 80124
United States, Connecticut
Site Reference ID/Investigator# 6723
Bridgeport, Connecticut, United States, 06606
Site Reference ID/Investigator# 6531
Hamden, Connecticut, United States, 06518
Site Reference ID/Investigator# 6660
Hartford, Connecticut, United States, 06106
Site Reference ID/Investigator# 6600
New Haven, Connecticut, United States, 06510
Site Reference ID/Investigator# 24444
New Haven, Connecticut, United States, 06510
Site Reference ID/Investigator# 6659
Stratford, Connecticut, United States, 06614
United States, Florida
Site Reference ID/Investigator# 7002
Hollywood, Florida, United States, 33021
Site Reference ID/Investigator# 8253
Jacksonville, Florida, United States, 32224
Site Reference ID/Investigator# 6907
Largo, Florida, United States, 33777
Site Reference ID/Investigator# 6725
Lauderdale Lakes, Florida, United States, 33319
Site Reference ID/Investigator# 16748
Naples, Florida, United States, 34102
Site Reference ID/Investigator# 7854
Orlando, Florida, United States, 32806
Site Reference ID/Investigator# 8017
Ormond Beach, Florida, United States, 32174
Site Reference ID/Investigator# 6197
Winter Park, Florida, United States, 32789
United States, Georgia
Site Reference ID/Investigator# 6755
Atlanta, Georgia, United States, 30342
Site Reference ID/Investigator# 18925
Augusta, Georgia, United States, 30912-3120
Site Reference ID/Investigator# 6619
Decatur, Georgia, United States, 30033
Site Reference ID/Investigator# 20544
Johns Creek, Georgia, United States, 30097
Site Reference ID/Investigator# 6668
Macon, Georgia, United States, 31201
Site Reference ID/Investigator# 6904
Marietta, Georgia, United States, 30067
United States, Illinois
Site Reference ID/Investigator# 8371
Chicago, Illinois, United States, 60637
Site Reference ID/Investigator# 14368
Chicago, Illinois, United States, 60612-3824
Site Reference ID/Investigator# 21381
Evanston, Illinois, United States, 60201
Site Reference ID/Investigator# 11622
Urbana, Illinois, United States, 61801
United States, Indiana
Site Reference ID/Investigator# 8271
Indianapolis, Indiana, United States, 46237
Site Reference ID/Investigator# 7372
Indianapolis, Indiana, United States, 46202
United States, Kansas
Site Reference ID/Investigator# 6625
Topeka, Kansas, United States, 66606
United States, Kentucky
Site Reference ID/Investigator# 8016
Louisville, Kentucky, United States, 40202
United States, Louisiana
Site Reference ID/Investigator# 7082
Lafayette, Louisiana, United States, 70503
Site Reference ID/Investigator# 6729
Shreveport, Louisiana, United States, 71103
United States, Maryland
Site Reference ID/Investigator# 6524
Annapolis, Maryland, United States, 21401
Site Reference ID/Investigator# 6418
Annapolis, Maryland, United States, 21401
Site Reference ID/Investigator# 19181
Baltimore, Maryland, United States, 21201
Site Reference ID/Investigator# 6730
Towson, Maryland, United States, 21286
Site Reference ID/Investigator# 7003
Wheaton, Maryland, United States, 20906
United States, Massachusetts
Site Reference ID/Investigator# 7951
Attleboro, Massachusetts, United States, 02703
Site Reference ID/Investigator# 9281
Boston, Massachusetts, United States, 02115
Site Reference ID/Investigator# 10450
Boston, Massachusetts, United States, 02215
United States, Michigan
Site Reference ID/Investigator# 23862
Ann Arbor, Michigan, United States, 48109
Site Reference ID/Investigator# 6522
Chesterfield, Michigan, United States, 48047
Site Reference ID/Investigator# 7660
Novi, Michigan, United States, 48377
Site Reference ID/Investigator# 6658
Troy, Michigan, United States, 48098
United States, Minnesota
Site Reference ID/Investigator# 7661
Plymouth, Minnesota, United States, 55446
Site Reference ID/Investigator# 6721
Rochester, Minnesota, United States, 55905
United States, Mississippi
Site Reference ID/Investigator# 8340
Ocean Spring, Mississippi, United States, 39564
United States, Missouri
Site Reference ID/Investigator# 6673
Mexico, Missouri, United States, 65265-3726
Site Reference ID/Investigator# 8173
St. Louis, Missouri, United States, 63110
Site Reference ID/Investigator# 15956
St. Louis, Missouri, United States, 63141
United States, Nebraska
Site Reference ID/Investigator# 14382
Omaha, Nebraska, United States, 68198-2000
United States, New Jersey
Site Reference ID/Investigator# 6527
Egg Harbor Township, New Jersey, United States, 08234
Site Reference ID/Investigator# 18926
Hillsborough, New Jersey, United States, 08844
Site Reference ID/Investigator# 6756
Manalapan, New Jersey, United States, 07726
Site Reference ID/Investigator# 20543
Marlton, New Jersey, United States, 08053
Site Reference ID/Investigator# 19684
Morristown, New Jersey, United States, 07960
Site Reference ID/Investigator# 17745
Mt. Laurel, New Jersey, United States, 08057
Site Reference ID/Investigator# 20301
New Brunswick, New Jersey, United States, 08903
Site Reference ID/Investigator# 6859
West Orange, New Jersey, United States, 07052
United States, New York
Site Reference ID/Investigator# 6620
Bay Shore, New York, United States, 11706
Site Reference ID/Investigator# 6378
Great Neck, New York, United States, 11021
Site Reference ID/Investigator# 7279
Mineola, New York, United States, 11501
Site Reference ID/Investigator# 15941
New York, New York, United States, 10016
Site Reference ID/Investigator# 20841
New York, New York, United States, 10075
Site Reference ID/Investigator# 10478
New York, New York, United States, 10021
Site Reference ID/Investigator# 6770
New York, New York, United States, 10128
Site Reference ID/Investigator# 7371
New York, New York, United States, 10028
Site Reference ID/Investigator# 6908
Poughkeepsie, New York, United States, 12601
Site Reference ID/Investigator# 6773
Troy, New York, United States, 12180
United States, North Carolina
Site Reference ID/Investigator# 7706
Asheville, North Carolina, United States, 28801
Site Reference ID/Investigator# 8451
Chapel Hill, North Carolina, United States, 27599-7080
Site Reference ID/Investigator# 6906
Charlotte, North Carolina, United States, 28211
Site Reference ID/Investigator# 6384
Charlotte, North Carolina, United States, 28207
Site Reference ID/Investigator# 7949
Durham, North Carolina, United States, 27710
Site Reference ID/Investigator# 8145
Greenville, North Carolina, United States, 27834
Site Reference ID/Investigator# 6675
Jacksonville, North Carolina, United States, 28546
Site Reference ID/Investigator# 6355
Rocky Mount, North Carolina, United States, 27804
Site Reference ID/Investigator# 6772
Wilmington, North Carolina, United States, 28401
Site Reference ID/Investigator# 6771
Wilmington, North Carolina, United States, 28403
Site Reference ID/Investigator# 8350
Winston-Salem, North Carolina, United States, 27157-1048
United States, Ohio
Site Reference ID/Investigator# 6719
Beachwood, Ohio, United States, 44122
Site Reference ID/Investigator# 6790
Canton, Ohio, United States, 44718
Site Reference ID/Investigator# 14064
Cleveland, Ohio, United States, 44106-5066
United States, Oklahoma
Site Reference ID/Investigator# 6664
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Site Reference ID/Investigator# 6724
Portland, Oregon, United States, 97225
Site Reference ID/Investigator# 20006
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Site Reference ID/Investigator# 20124
Altoona, Pennsylvania, United States, 16602
Site Reference ID/Investigator# 8346
Philadelphia, Pennsylvania, United States, 19107
Site Reference ID/Investigator# 8257
Pittsburgh, Pennsylvania, United States, 15213
Site Reference ID/Investigator# 8144
Pittsburgh, Pennsylvania, United States, 15232
Site Reference ID/Investigator# 20022
Sayre, Pennsylvania, United States, 18840
United States, South Carolina
Site Reference ID/Investigator# 8266
Charleston, South Carolina, United States, 29425
United States, South Dakota
Site Reference ID/Investigator# 7282
Sioux Falls, South Dakota, United States, 57108
United States, Tennessee
Site Reference ID/Investigator# 6202
Chattanooga, Tennessee, United States, 37421
Site Reference ID/Investigator# 6624
Germantown, Tennessee, United States, 38138
United States, Texas
Site Reference ID/Investigator# 6595
Houston, Texas, United States, 77030
Site Reference ID/Investigator# 20885
Plano, Texas, United States, 75075
United States, Utah
Site Reference ID/Investigator# 9662
Salt Lake City, Utah, United States, 84132-2410
United States, Virginia
Site Reference ID/Investigator# 6726
Charlottesville, Virginia, United States, 22908
Site Reference ID/Investigator# 22201
Fairfax, Virginia, United States, 22031
Site Reference ID/Investigator# 22664
Richmond, Virginia, United States, 23298
United States, Washington
Site Reference ID/Investigator# 7853
Seattle, Washington, United States, 98195
Site Reference ID/Investigator# 6200
Spokane, Washington, United States, 99204
Site Reference ID/Investigator# 6797
Tacoma, Washington, United States, 98405
United States, Wisconsin
Site Reference ID/Investigator# 8014
Madison, Wisconsin, United States, 53792-5124
Site Reference ID/Investigator# 7705
Milwaukee, Wisconsin, United States, 53226
Site Reference ID/Investigator# 6521
Milwaukee, Wisconsin, United States, 53215
Site Reference ID/Investigator# 7855
Summit, Wisconsin, United States, 53066
Site Reference ID/Investigator# 6655
West Bend, Wisconsin, United States, 53095
Australia
Site Reference ID/Investigator# 15942
Adelaide, Australia, 5000
Site Reference ID/Investigator# 11602
Bedford Park, Australia, 5042
Site Reference ID/Investigator# 11626
Box Hill, Australia, 3128
Site Reference ID/Investigator# 19505
Camperdown, Australia, 2050
Site Reference ID/Investigator# 19501
Concord, Australia, 2139
Site Reference ID/Investigator# 12741
Fitzroy Victoria, Australia, 3065
Site Reference ID/Investigator# 19486
Fremantle, Australia, 6160
Site Reference ID/Investigator# 15021
Herston, Australia, 4029
Site Reference ID/Investigator# 11624
Launceston, Australia, 7250
Site Reference ID/Investigator# 14065
New Lambton Heights, Australia, 2305
Site Reference ID/Investigator# 11683
Parkville, Australia, 3050
Austria
Site Reference ID/Investigator# 7975
Dornbirn, Austria, A-6850
Site Reference ID/Investigator# 7275
Graz, Austria, 8020
Site Reference ID/Investigator# 7283
Graz, Austria, 8020
Site Reference ID/Investigator# 7976
Linz, Austria, A-4010
Site Reference ID/Investigator# 7649
Linz, Austria, 4020
Site Reference ID/Investigator# 7680
Linz, Austria, 4021
Site Reference ID/Investigator# 7969
Oberpullendorf, Austria, 7350
Site Reference ID/Investigator# 8333
Ried Im Innkreis, Austria, A-4910
Site Reference ID/Investigator# 7682
Salzburg, Austria, 5010
Site Reference ID/Investigator# 7648
Salzburg, Austria, A-5020
Site Reference ID/Investigator# 7681
St. Veit/Glan, Austria, 9300
Site Reference ID/Investigator# 8282
Vienna, Austria, 1090
Site Reference ID/Investigator# 7271
Vienna, Austria, 1030
Site Reference ID/Investigator# 7683
Vienna, Austria, 1160
Site Reference ID/Investigator# 7650
Vienna, Austria, 1130
Site Reference ID/Investigator# 7836
Wels, Austria, A-4600
Site Reference ID/Investigator# 7647
Wiener Neustadt, Austria, 2700
Belgium
Site Reference ID/Investigator# 7839
Bonheiden, Belgium, 2820
Site Reference ID/Investigator# 7849
Brussels, Belgium, 1090
Site Reference ID/Investigator# 7968
Brussels, Belgium, 1200
Site Reference ID/Investigator# 7838
Edegem, Belgium, 2650
Site Reference ID/Investigator# 10461
Ghent, Belgium, 9000
Site Reference ID/Investigator# 7971
Leuven, Belgium, 3000
Site Reference ID/Investigator# 7967
Liege, Belgium, 4000
Site Reference ID/Investigator# 8332
Roeselare, Belgium, 8800
Canada
Site Reference ID/Investigator# 7480
Abbotsford, Canada, V2S 3N5
Site Reference ID/Investigator# 6766
Barrie, Canada, L4M 7G1
Site Reference ID/Investigator# 8330
Calgary, Canada, T2N 4N1
Site Reference ID/Investigator# 7086
Guelph, Canada, N1H 3R3
Site Reference ID/Investigator# 7471
Halifax, Canada, B3H 2Y9
Site Reference ID/Investigator# 7278
Hamilton, Canada, L8N 4A6
Site Reference ID/Investigator# 7517
Hamilton, Canada, L8S 4K1
Site Reference ID/Investigator# 6789
Kelowna, Canada, V1Y 1Z9
Site Reference ID/Investigator# 7273
Levis, Canada, G6V 3Z1
Site Reference ID/Investigator# 7848
London, Canada, N6A 5K8
Site Reference ID/Investigator# 7386
Longueuil, Canada, J4N 1C2
Site Reference ID/Investigator# 9669
Montreal, Canada, H1T 2M4
Site Reference ID/Investigator# 14362
Montreal, Canada, H3A 1A1
Site Reference ID/Investigator# 7965
Montreal, Canada, H3T 1E2
Site Reference ID/Investigator# 7834
Montreal, Canada, H2X 3J4
Site Reference ID/Investigator# 9382
Ottawa, Canada, K1H 8L6
Site Reference ID/Investigator# 10464
Quebec City, Canada, G1S 4L8
Site Reference ID/Investigator# 13543
Saint-Charles-Borromee, Canada, J6E 2C3
Site Reference ID/Investigator# 17722
Saskatoon, Canada, S7N 0W8
Site Reference ID/Investigator# 8369
Saskatoon, Canada, S7K 1N4
Site Reference ID/Investigator# 10463
Saskatoon, Canada, S7K 1J5
Site Reference ID/Investigator# 7847
Scarborough, Canada, M1S 4V5
Site Reference ID/Investigator# 6909
St. John's, Canada, A1C 2H5
Site Reference ID/Investigator# 8269
St. John's, Canada, E2K 1J5
Site Reference ID/Investigator# 8322
Toronto, Canada, M5G 2C4
Site Reference ID/Investigator# 10948
Toronto, Canada, M4N 3M5
Site Reference ID/Investigator# 7651
Truro, Canada, B2N 1L2
Site Reference ID/Investigator# 10462
Vancouver, Canada, V6Z-2K5
Site Reference ID/Investigator# 6862
Vancouver, Canada, V5Z 1H2
Site Reference ID/Investigator# 7112
Victoria, Canada, V8V 3P9
Site Reference ID/Investigator# 7966
Victoria, Canada, V8T 5G4
Site Reference ID/Investigator# 7185
Winnipeg, Canada, R3A 1R9
Czech Republic
Site Reference ID/Investigator# 18121
Brno, Czech Republic, 625 00
Site Reference ID/Investigator# 9383
Ceske Budejovice, Czech Republic, 37001
Site Reference ID/Investigator# 8255
Hradec Kralove, Czech Republic, 500 12
Site Reference ID/Investigator# 9665
Liberec, Czech Republic, 46 063
Site Reference ID/Investigator# 9389
Olomouc, Czech Republic, 77520
Site Reference ID/Investigator# 8268
Ostrava, Czech Republic, 708 52
Site Reference ID/Investigator# 17547
Prague 2, Czech Republic, 12808
Site Reference ID/Investigator# 10442
Prague 4, Czech Republic, 14021
Site Reference ID/Investigator# 17546
Prague 4, Czech Republic, 14059
Site Reference ID/Investigator# 18441
Prague 5, Czech Republic, 15030
Site Reference ID/Investigator# 8376
Prague 7, Czech Republic, 17004
Site Reference ID/Investigator# 17548
Usti nad Labem, Czech Republic, 40113
Denmark
Site Reference ID/Investigator# 6901
Aalborg, Denmark, 9000
Site Reference ID/Investigator# 6768
Arhus C, Denmark, 8000
Site Reference ID/Investigator# 14066
Copenhagen, Denmark, 2100
Site Reference ID/Investigator# 8011
Hillerod, Denmark, 3400
Site Reference ID/Investigator# 7645
Hvidovre, Denmark, 2650
Site Reference ID/Investigator# 15943
Koge, Denmark, 4600
Site Reference ID/Investigator# 8141
Odense C, Denmark, 5000
France
Site Reference ID/Investigator# 9667
Amiens, France, 80054
Site Reference ID/Investigator# 10467
Bethune, France, 62408
Site Reference ID/Investigator# 9395
Clichy, France, 92110
Site Reference ID/Investigator# 9394
Columbes, France, 92701
Site Reference ID/Investigator# 12742
Creteil, France, 94010
Site Reference ID/Investigator# 9396
Grenoble, France, 38043
Site Reference ID/Investigator# 9393
Lille Cedex, France, 59037
Site Reference ID/Investigator# 9385
Montfermeil, France, 93370
Site Reference ID/Investigator# 9390
Nice, France, 06202
Site Reference ID/Investigator# 9666
Paris, France, 75571
Site Reference ID/Investigator# 10465
Paris, France, 75014
Site Reference ID/Investigator# 19403
Paris Cedex 10, France, 75475
Site Reference ID/Investigator# 12723
Paris Cedex 18, France, 75018
Site Reference ID/Investigator# 9388
Pessac Cedex, France, 33600
Site Reference ID/Investigator# 10947
Reims, France, 51092
Site Reference ID/Investigator# 9387
Rouen, France, 76031
Site Reference ID/Investigator# 9386
Toulouse, France, 31059
Site Reference ID/Investigator# 10466
Tours Cedex, France, 37044
Germany
Site Reference ID/Investigator# 7666
Berlin, Germany, 13353
Site Reference ID/Investigator# 7974
Berlin, Germany, 12200
Site Reference ID/Investigator# 7674
Berlin, Germany, 10318
Site Reference ID/Investigator# 8003
Berlin, Germany, 10117
Site Reference ID/Investigator# 7981
Berlin, Germany, 13353
Site Reference ID/Investigator# 7837
Bochum, Germany, 44791
Site Reference ID/Investigator# 8172
Braunschweig, Germany, 38126
Site Reference ID/Investigator# 11627
Dresden, Germany, 01067
Site Reference ID/Investigator# 7964
Erlangen, Germany, 91054
Site Reference ID/Investigator# 7673
Essen, Germany, 45239
Site Reference ID/Investigator# 9392
Frankfurt, Germany, 60318
Site Reference ID/Investigator# 8329
Freiburg, Germany, 79106
Site Reference ID/Investigator# 7835
Halle, Germany, 06120
Site Reference ID/Investigator# 7970
Hamburg, Germany, 22297
Site Reference ID/Investigator# 8004
Hamburg, Germany, 20148
Site Reference ID/Investigator# 8143
Hamburg, Germany, 22559
Site Reference ID/Investigator# 7672
Hannover, Germany, 30625
Site Reference ID/Investigator# 7961
Heidelberg, Germany, 69120
Site Reference ID/Investigator# 7678
Herne, Germany, 44623
Site Reference ID/Investigator# 10946
Homburg, Germany, 66424
Site Reference ID/Investigator# 8328
Jena Lebeda Ost, Germany, 07747
Site Reference ID/Investigator# 7665
Leipzig, Germany, 04105
Site Reference ID/Investigator# 8338
Leipzig, Germany, 04103
Site Reference ID/Investigator# 10468
Luebeck, Germany, 23538
Site Reference ID/Investigator# 11682
Lueneburg, Germany, 21339
Site Reference ID/Investigator# 7675
Magdeburg, Germany, 39120
Site Reference ID/Investigator# 11902
Markkleeberg, Germany, 04416
Site Reference ID/Investigator# 7679
Minden, Germany, 32423
Site Reference ID/Investigator# 11621
Muenster, Germany, 48155
Site Reference ID/Investigator# 10945
Muenster, Germany, 48129
Site Reference ID/Investigator# 7676
Muenster, Germany, 48159
Site Reference ID/Investigator# 19503
Munich, Germany
Site Reference ID/Investigator# 7677
Munich, Germany, 80639
Site Reference ID/Investigator# 7667
Regensburg, Germany, 93042
Site Reference ID/Investigator# 7982
Stade, Germany, 21682
Site Reference ID/Investigator# 19506
Stuttgart, Germany, D-70376
Greece
Site Reference ID/Investigator# 20842
Alexandroupolis, Greece, 68100
Site Reference ID/Investigator# 20342
Alexandroupolis, Greece, 68100
Site Reference ID/Investigator# 18923
Athens, Greece, 10676
Site Reference ID/Investigator# 20125
Athens, Greece, 106 76
Site Reference ID/Investigator# 7993
Athens, Greece, 11526
Site Reference ID/Investigator# 9275
Athens, Greece, 10552
Site Reference ID/Investigator# 10949
Athens, Greece, 124 62
Site Reference ID/Investigator# 20344
Athens, Greece, 12351
Site Reference ID/Investigator# 13545
Athens, Greece, 142 33
Site Reference ID/Investigator# 18922
Athens, Greece, 115 27
Site Reference ID/Investigator# 22182
Athens, Greece, 11527
Site Reference ID/Investigator# 20121
Athens, Greece, 11527
Site Reference ID/Investigator# 20561
Athens, Greece, 11572
Site Reference ID/Investigator# 19541
Athens, Greece, 11526
Site Reference ID/Investigator# 20546
Crete, Greece, 71409
Site Reference ID/Investigator# 22165
Heraklion, Greece, 71100
Site Reference ID/Investigator# 22181
Ioannina, Greece, 45500
Site Reference ID/Investigator# 20122
Larisa, Greece, 41355
Site Reference ID/Investigator# 7850
Maroussi Athens, Greece, 15125
Site Reference ID/Investigator# 19483
Maroussi Athens, Greece, 15123
Site Reference ID/Investigator# 19485
Melissia Athens, Greece, 15127
Site Reference ID/Investigator# 20641
Nikaia, Greece, 184 54
Site Reference ID/Investigator# 7985
Paleo Faliro, Greece, 17562
Site Reference ID/Investigator# 20345
Piraeus, Greece, 18536
Site Reference ID/Investigator# 20003
Rio, Greece, 26500
Site Reference ID/Investigator# 18522
Thessaloniki, Greece, 57010
Site Reference ID/Investigator# 20123
Thessaloniki, Greece, 54642
Site Reference ID/Investigator# 20002
Thessaloniki, Greece
Site Reference ID/Investigator# 20545
Thessaloniki, Greece, 54642
Site Reference ID/Investigator# 14363
Volos, Greece, 38222
Hungary
Site Reference ID/Investigator# 16706
Budapest, Hungary, 1088
Site Reference ID/Investigator# 16707
Debrecen, Hungary, 4012
Site Reference ID/Investigator# 17802
Kaposvar, Hungary, 7400
Iceland
Site Reference ID/Investigator# 8373
Reykjavik, Iceland, 104
Ireland
Site Reference ID/Investigator# 7663
Dublin, Ireland, D24
Site Reference ID/Investigator# 8142
Dublin 4, Ireland
Site Reference ID/Investigator# 9277
Dublin 7, Ireland
Site Reference ID/Investigator# 7664
Dublin 9, Ireland
Site Reference ID/Investigator# 8339
Galway, Ireland
Italy
Site Reference ID/Investigator# 12083
Como, Italy, 22100
Site Reference ID/Investigator# 19402
Messina, Italy, 98125
Site Reference ID/Investigator# 19504
Naples, Italy, 80100
Site Reference ID/Investigator# 10471
Naples, Italy, 80131
Site Reference ID/Investigator# 14983
Padua, Italy, 35218
Site Reference ID/Investigator# 13547
Palermo, Italy, 90146
Site Reference ID/Investigator# 18929
Pavia, Italy, 27100
Site Reference ID/Investigator# 19502
Pescara, Italy, 65124
Site Reference ID/Investigator# 11903
Rome, Italy, 00153
Site Reference ID/Investigator# 24582
Rome, Italy, 00133
Site Reference ID/Investigator# 17803
Rome, Italy, 00168
Site Reference ID/Investigator# 13546
Rome, Italy, 00152
Site Reference ID/Investigator# 14364
Rozzano, Italy, 20089
Site Reference ID/Investigator# 19683
San Donato Milanese - Milan, Italy, 20097
Site Reference ID/Investigator# 10470
San Giovanni Rotondo (Foggia), Italy, 71013
Netherlands
Site Reference ID/Investigator# 7978
Amsterdam, Netherlands, 1105 AZ
Site Reference ID/Investigator# 7277
Den Helder, Netherlands, 178262
Site Reference ID/Investigator# 9381
Heerlen, Netherlands, 6419 PC
Site Reference ID/Investigator# 10472
Leiden, Netherlands, 2333 ZA
Site Reference ID/Investigator# 8254
Sittard, Netherlands, 6131 BK
Site Reference ID/Investigator# 13548
Tilburg, Netherlands, 5022 GC
Site Reference ID/Investigator# 10444
Zwolle, Netherlands, 8025 AB
New Zealand
Site Reference ID/Investigator# 14365
Auckland, New Zealand, 1148
Site Reference ID/Investigator# 9661
Christchurch, New Zealand, 8011
Norway
Site Reference ID/Investigator# 19482
Fredrikstad, Norway, 1606
Site Reference ID/Investigator# 19621
Hamar, Norway, 2318
Site Reference ID/Investigator# 14366
Harstad, Norway, 9480
Site Reference ID/Investigator# 19542
Oslo, Norway, 0407
Site Reference ID/Investigator# 18941
Oslo, Norway, 0027
Site Reference ID/Investigator# 15022
Oslo, Norway, 0514
Site Reference ID/Investigator# 10475
Trondheim, Norway, 7006
Portugal
Site Reference ID/Investigator# 19481
Almada, Portugal, 2801-951
Site Reference ID/Investigator# 10445
Lisbon, Portugal, 1099-023
Site Reference ID/Investigator# 20005
Lisbon, Portugal, 1150-314
Site Reference ID/Investigator# 8370
Lisbon, Portugal, 1349-019
Site Reference ID/Investigator# 17744
Porto, Portugal, 4200-319
Slovakia
Site Reference ID/Investigator# 8336
Banska Bystrica, Slovakia, 97 401
Site Reference ID/Investigator# 15023
Bratislava, Slovakia, 82696
Site Reference ID/Investigator# 8259
Bratislava, Slovakia, 831 04
Site Reference ID/Investigator# 15944
Bratislava, Slovakia, 851 07
Site Reference ID/Investigator# 8267
Nitra, Slovakia, 94 901
Site Reference ID/Investigator# 8260
Presov, Slovakia, 08001
Site Reference ID/Investigator# 8258
Trnava, Slovakia, 917 01
Slovenia
Site Reference ID/Investigator# 18523
Ljubljana, Slovenia, 1000
South Africa
Site Reference ID/Investigator# 17724
Assagay, South Africa, 3610
Site Reference ID/Investigator# 18924
Cape Town, South Africa, 7708
Site Reference ID/Investigator# 19401
Greenacres, South Africa
Site Reference ID/Investigator# 17804
Johannesburg, South Africa, 2193
Site Reference ID/Investigator# 19523
Panorama, South Africa, 7500
Spain
Site Reference ID/Investigator# 15946
A Coruna, Spain, 15006
Site Reference ID/Investigator# 19685
Alcazar de San Juan, Spain, 13600
Site Reference ID/Investigator# 18529
Alcorcon, Spain, 28921
Site Reference ID/Investigator# 15947
Alicante, Spain, 03010
Site Reference ID/Investigator# 18528
Alicante, Spain, 03550
Site Reference ID/Investigator# 15951
Almeria, Spain, 04009
Site Reference ID/Investigator# 17743
Badajoz, Spain, 06300
Site Reference ID/Investigator# 11905
Badalona - Barcelona, Spain, 08916
Site Reference ID/Investigator# 15945
Barcelona, Spain, 08208
Site Reference ID/Investigator# 16744
Barcelona, Spain, 08097
Site Reference ID/Investigator# 11906
Barcelona, Spain, 08003
Site Reference ID/Investigator# 12743
Barcelona, Spain, 08036
Site Reference ID/Investigator# 15953
Barcelona, Spain, 08025
Site Reference ID/Investigator# 24282
Bilbao, Spain, 48013
Site Reference ID/Investigator# 14982
Burgos, Spain, 09005
Site Reference ID/Investigator# 16742
Cabuenes-Gijon, Spain, 33203
Site Reference ID/Investigator# 25103
Caceres, Spain, 10003
Site Reference ID/Investigator# 14981
Cordoba, Spain, 14004
Site Reference ID/Investigator# 16741
Cuenca, Spain, 16002
Site Reference ID/Investigator# 15954
Cuidad Real, Spain, 13005
Site Reference ID/Investigator# 16703
Donostia-San Sebastian, Spain, 20014
Site Reference ID/Investigator# 14367
El Ejido, Spain, 04700
Site Reference ID/Investigator# 18525
El Palmar, Spain, 30120
Site Reference ID/Investigator# 17723
Elche, Spain, 03203
Site Reference ID/Investigator# 15950
Huelva, Spain, 21005
Site Reference ID/Investigator# 13555
Jaen, Spain, 23007
Site Reference ID/Investigator# 18526
Jerez, Spain, 11407
Site Reference ID/Investigator# 13553
La Laguna, Spain, 38320
Site Reference ID/Investigator# 15024
Las Palmas de Gran Canaria, Spain, 35020
Site Reference ID/Investigator# 15952
Leon, Spain, 24080
Site Reference ID/Investigator# 18527
Lorca, Spain, 30800
Site Reference ID/Investigator# 16705
Madrid, Spain, 28009
Site Reference ID/Investigator# 10447
Madrid, Spain, 28046
Site Reference ID/Investigator# 9670
Madrid, Spain, 28006
Site Reference ID/Investigator# 13550
Madrid, Spain, 28040
Site Reference ID/Investigator# 9664
Madrid, Spain, 28041
Site Reference ID/Investigator# 10474
Madrid, Spain, 28040
Site Reference ID/Investigator# 13549
Madrid, Spain, 28942
Site Reference ID/Investigator# 10449
Majadahonda (Madrid), Spain, 28222
Site Reference ID/Investigator# 17761
Malaga, Spain, 29010
Site Reference ID/Investigator# 17741
Marbella, Spain, 29600
Site Reference ID/Investigator# 18530
Murcia, Spain, 30008
Site Reference ID/Investigator# 10448
Palma de Mallorca, Spain, 07198
Site Reference ID/Investigator# 15949
Palma de Mallorca, Spain, 07014
Site Reference ID/Investigator# 9663
Pontevedra, Spain, 36071
Site Reference ID/Investigator# 19681
Puerto de Sagunto, Spain, 46520
Site Reference ID/Investigator# 16882
Salamanca, Spain, 37007
Site Reference ID/Investigator# 16702
Santa Cruz de Tenerife, Spain, 38010
Site Reference ID/Investigator# 19682
Santander, Spain, 39008
Site Reference ID/Investigator# 16743
Santiago de Compostela, Spain, 15706
Site Reference ID/Investigator# 13552
Seville, Spain, 41007
Site Reference ID/Investigator# 16883
Seville, Spain, 41013
Site Reference ID/Investigator# 16701
Terrasa Barcelona, Spain, 08227
Site Reference ID/Investigator# 16704
Toledo, Spain, 45004
Site Reference ID/Investigator# 10446
Valladolid, Spain, 47010
Site Reference ID/Investigator# 15955
Vigo/Pontevedra, Spain, 36200
Site Reference ID/Investigator# 15025
Zaragoza, Spain, 50009
Site Reference ID/Investigator# 11904
Zaragoza, Spain, 50009
Sweden
Site Reference ID/Investigator# 8151
Boras, Sweden, 50182
Site Reference ID/Investigator# 8327
Gothenburg, Sweden, 41345
Site Reference ID/Investigator# 7851
Gothenburg, Sweden, 416 85
Site Reference ID/Investigator# 7973
Jonkoping, Sweden, 55185
Site Reference ID/Investigator# 8150
Linkoping, Sweden, 581 85
Site Reference ID/Investigator# 8002
Lund, Sweden, 22185
Site Reference ID/Investigator# 7852
Malmo, Sweden, SE-20502
Site Reference ID/Investigator# 7983
Stockholm, Sweden, 171 76
Site Reference ID/Investigator# 7984
Stockholm, Sweden, 114 86
United Kingdom
Site Reference ID/Investigator# 9391
Cardiff, United Kingdom, CF14 4XW
Site Reference ID/Investigator# 9384
Edinburgh, United Kingdom, EH4 2XU
Site Reference ID/Investigator# 16710
Liverpool, United Kingdom, L7 8XP
Site Reference ID/Investigator# 16708
London, United Kingdom, SE1 7EH
Site Reference ID/Investigator# 10477
London, United Kingdom, W12 OHS
Site Reference ID/Investigator# 8455
London, United Kingdom, W2 1NY
Site Reference ID/Investigator# 18921
Manchester, United Kingdom, M13 9WL
Site Reference ID/Investigator# 20547
Oxford, United Kingdom, OX3 9DU
Site Reference ID/Investigator# 7856
Plymouth, United Kingdom, PL6 8DH
Site Reference ID/Investigator# 8140
Portsmouth, United Kingdom, PO6 3LY
Site Reference ID/Investigator# 11684
West Midlands, United Kingdom, WV10 0QP
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Roopal B Thakkar, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00524537     History of Changes
Other Study ID Numbers: P06-134
Study First Received: August 31, 2007
Last Updated: April 8, 2014
Health Authority: Slovakia: State Institute for Drug Control
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Iceland: Icelandic Medicines Control Agency
Denmark: Danish Medicines Agency
Sweden: Medical Products Agency
Portugal: National Pharmacy and Medicines Institute
Hungary: National Institute of Pharmacy
Italy: The Italian Medicines Agency
Germany: Paul-Ehrlich-Institut
Norway: Norwegian Medicines Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Ireland: Irish Medicines Board
South Africa: Medicines Control Council
New Zealand: Medsafe
Czech Republic: State Institute for Drug Control
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Slovenia: Agency for Medicinal Products - Ministry of Health
Greece: Ministry of Health and Welfare
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by AbbVie:
Crohn's Disease

Additional relevant MeSH terms:
Adalimumab
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 21, 2014