Effectiveness and Safety in Patients With Crohn´s Disease in Clinical Routine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01083680
First received: February 26, 2010
Last updated: January 25, 2016
Last verified: January 2016
  Purpose
This study is intended to evaluate the long-term safety and effectiveness of adalimumab in Crohn's Disease patients who are treated as recommended in the product label.

Condition
Crohn´s Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Postmarketing Observational Study to Evaluate the Safety and Efficacy of HUMIRA (Adalimumab sc) for the Treatment of Moderate to Severe Crohn's Disease in Daily Clinical Practice

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Improvement/resolution of signs and symptoms of the acute Crohn's disease (CDAI -100), [ Time Frame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 ] [ Designated as safety issue: Yes ]
  • Compliance with the self-injection via the HUMIRA-PEN, [ Time Frame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 ] [ Designated as safety issue: No ]
  • Rate of adverse events [ Time Frame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 ] [ Designated as safety issue: Yes ]
  • Long-term improvement of patients Quality of Life [ Time Frame: Months 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 ] [ Designated as safety issue: No ]

Enrollment: 3969
Study Start Date: June 2007
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Crohn's Disease patients
Patients with Crohn's Disease

Detailed Description:

Subjects are to be treated in accordance with the most current local product label. Patients will be seen at the site at study enrollment and then at routine office visits through completion of the study (up to 5 years). Subjects will be followed according to normal clinical practice. Adverse events of interest (including reports of opportunistic infections, such as tuberculosis [TB], other serious infections, occurrence of intestinal stricture, new malignancies, lupus/lupus-like illness, demyelinating disorders, congestive heart failure), and serious adverse events (SAE) will be recorded throughout the study. In addition, adverse events of interest will be reported at any time after the last dose if the Investigator believes the event to be related to adalimumab treatment.

Information to evaluate the effectiveness of adalimumab therapy will be collected through administration of patient-reported outcome measurements (PROs) and Physician assessments of disease activity if assessed as part of clinical practice at the study enrollment visit and at subsequent routine visits. The following PROs will be used: Short Inflammatory Bowel Disease Questionnaire (SIBDQ), Health Care Resource Utilization and Work Productivity and Activity Impairment. The Physician assessment of disease activity will be collected using the Physician Global Assessments Form. Information about medications taken for CD will be collected.

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community sample: patients with Crohn's Disease
Criteria

Inclusion Criteria: - Severe, active Crohn's Disease in patients with insufficient response to a complete and adequate therapy of glucocorticoid and/or immunosuppressive drug and/or hypersensitivity against such a therapy or in patients where such a therapy is contraindicated.

Exclusion Criteria: - Hypersensitivity against the drug or one of the other ingredients

  • active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections)
  • Moderate to severe cardiac insufficiency.
  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: NCT01083680

  Hide Study Locations
Locations
Germany
Site Reference ID/Investigator# 58770
Aachen, Germany, 52074
Site Reference ID/Investigator# 91100
Aichhalden, Germany, 78733
Site Reference ID/Investigator# 48900
Altenburg, Germany, 04600
Site Reference ID/Investigator# 64006
Altenholz, Germany, 24161
Site Reference ID/Investigator# 35047
Alzey, Germany, 55232
Site Reference ID/Investigator# 125626
Andernach, Germany, 56626
Site Reference ID/Investigator# 35062
Augsburg, Germany, 86150
Site Reference ID/Investigator# 48899
Bad Berka, Germany, 99438
Site Reference ID/Investigator# 58751
Bad Homburg, Germany, 61348
Site Reference ID/Investigator# 67702
Bad Homburg, Germany, 61348
Site Reference ID/Investigator# 48888
Bad Lausick, Germany, 04651
Site Reference ID/Investigator# 53216
Bad Salzungen, Germany, 36433
Site Reference ID/Investigator# 73842
Bad Wildungen, Germany, 34537
Site Reference ID/Investigator# 73847
Baden-Baden, Germany, 76530
Site Reference ID/Investigator# 33443
Bayreuth, Germany, 95444
Site Reference ID/Investigator# 53217
Bayreuth, Germany, 95444
Site Reference ID/Investigator# 125625
Beilngries, Germany, 92339
Site Reference ID/Investigator# 145596
Bergisch Gladbach, Germany, 51465
Site Reference ID/Investigator# 33698
Berlin, Germany, 10117
Site Reference ID/Investigator# 48883
Berlin, Germany, 10117
Site Reference ID/Investigator# 33700
Berlin, Germany, 10249
Site Reference ID/Investigator# 33679
Berlin, Germany, 10318
Site Reference ID/Investigator# 33663
Berlin, Germany, 10367
Site Reference ID/Investigator# 33701
Berlin, Germany, 10437
Site Reference ID/Investigator# 34242
Berlin, Germany, 10437
Site Reference ID/Investigator# 34240
Berlin, Germany, 10713
Site Reference ID/Investigator# 34244
Berlin, Germany, 10719
Site Reference ID/Investigator# 33671
Berlin, Germany, 10825
Site Reference ID/Investigator# 33699
Berlin, Germany, 10825
Site Reference ID/Investigator# 58758
Berlin, Germany, 10825
Site Reference ID/Investigator# 33455
Berlin, Germany, 12200
Site Reference ID/Investigator# 73846
Berlin, Germany, 12437
Site Reference ID/Investigator# 33684
Berlin, Germany, 12619
Site Reference ID/Investigator# 91101
Berlin, Germany, 12619
Site Reference ID/Investigator# 58749
Berlin, Germany, 12621
Site Reference ID/Investigator# 33706
Berlin, Germany, 13086
Site Reference ID/Investigator# 58764
Berlin, Germany, 13125
Site Reference ID/Investigator# 33643
Berlin, Germany, 13353
Site Reference ID/Investigator# 6070
Berlin, Germany, 13353
Site Reference ID/Investigator# 33645
Berlin, Germany, 13437
Site Reference ID/Investigator# 34248
Berlin, Germany, 14089
Site Reference ID/Investigator# 73834
Bernau, Germany, 83233
Site Reference ID/Investigator# 105656
Biberach, Germany, 88400
Site Reference ID/Investigator# 34278
Bielefeld, Germany, 33609
Site Reference ID/Investigator# 125629
Bielefeld, Germany, 33649
Site Reference ID/Investigator# 73835
Bitburg, Germany, 54634
Site Reference ID/Investigator# 34281
Bitterfeld, Germany, 6749
Site Reference ID/Investigator# 125624
Bocholt, Germany, 46397
Site Reference ID/Investigator# 58765
Bochum, Germany, 44787
Site Reference ID/Investigator# 73843
Bonn, Germany, 53111
Site Reference ID/Investigator# 53273
Bonn, Germany, 53115
Site Reference ID/Investigator# 53237
Bonn, Germany, 53173
Site Reference ID/Investigator# 53253
Bonn, Germany, 53225
Site Reference ID/Investigator# 34304
Brandenburg, Germany, 14776
Site Reference ID/Investigator# 35654
Braunschweig, Germany, 38100
Site Reference ID/Investigator# 48902
Bremen, Germany, 28259
Site Reference ID/Investigator# 105638
Bremerhaven, Germany, 27570
Site Reference ID/Investigator# 34690
Bremervoerde, Germany, 27432
Site Reference ID/Investigator# 48884
Buchholz, Germany, 21244
Site Reference ID/Investigator# 34693
Buende, Germany, 32257
Site Reference ID/Investigator# 53178
Buende, Germany, 32257
Site Reference ID/Investigator# 53282
Burglengenfeld, Germany, 93133
Site Reference ID/Investigator# 144061
Chemnitz, Germany, 09111
Site Reference ID/Investigator# 137305
Chemnitz, Germany, 09130
Site Reference ID/Investigator# 53143
Chemnitz, Germany, 09130
Site Reference ID/Investigator# 34701
Chemnitz, Germany, 9126
Site Reference ID/Investigator# 34702
Chemnitz, Germany, 9127
Site Reference ID/Investigator# 34705
Coburg, Germany, 96450
Site Reference ID/Investigator# 34706
Coesfeld, Germany, 48653
Site Reference ID/Investigator# 53152
Coesfeld, Germany, 48653
Site Reference ID/Investigator# 53124
Cologne, Germany, 51063
Site Reference ID/Investigator# 125623
Cologne, Germany, 51103
Site Reference ID/Investigator# 53342
Cottbus, Germany, 03046
Site Reference ID/Investigator# 34713
Cottbus, Germany, 3048
Site Reference ID/Investigator# 34714
Cottbus, Germany, 3048
Site Reference ID/Investigator# 53285
Dachau, Germany, 85221
Site Reference ID/Investigator# 137361
Damme, Germany, 49401
Site Reference ID/Investigator# 34719
Darmstadt, Germany, 64283
Site Reference ID/Investigator# 53157
Darmstadt, Germany, 64287
Site Reference ID/Investigator# 35623
Darmstadt, Germany, 64293
Site Reference ID/Investigator# 35624
Darmstadt, Germany, 64293
Site Reference ID/Investigator# 34721
Datteln, Germany, 45711
Site Reference ID/Investigator# 58776
Detmold, Germany, 32756
Site Reference ID/Investigator# 34732
Dingolfing, Germany, 84130
Site Reference ID/Investigator# 34733
Dinkelsbuehl, Germany, 91550
Site Reference ID/Investigator# 34735
Dippoldiswalde, Germany, 1744
Site Reference ID/Investigator# 34743
Dortmund, Germany, 44263
Site Reference ID/Investigator# 34761
Dresden, Germany, 01067
Site Reference ID/Investigator# 73841
Dresden, Germany, 01069
Site Reference ID/Investigator# 34757
Dresden, Germany, 1279
Site Reference ID/Investigator# 35638
Dresden, Germany, 1307
Site Reference ID/Investigator# 34745
Dresden, Germany, 1309
Site Reference ID/Investigator# 34770
Duesseldorf, Germany, 40237
Site Reference ID/Investigator# 48895
Ebern, Germany, 96106
Site Reference ID/Investigator# 99800
Eichstaett, Germany, 85072
Site Reference ID/Investigator# 48898
Eisenach, Germany, 99817
Site Reference ID/Investigator# 34791
Ellefeld, Germany, 8236
Site Reference ID/Investigator# 34798
Emden, Germany, 26721
Site Reference ID/Investigator# 137295
Emsdetten, Germany, 48282
Site Reference ID/Investigator# 34806
Erfurt, Germany, 99084
Site Reference ID/Investigator# 35192
Erlangen, Germany, 91052
Site Reference ID/Investigator# 125622
Erlangen, Germany, 91054
Site Reference ID/Investigator# 34818
Erlangen, Germany, 91054
Site Reference ID/Investigator# 34822
Eschweiler, Germany, 52249
Site Reference ID/Investigator# 53168
Essen, Germany, 45138
Site Reference ID/Investigator# 91102
Essen, Germany, 45147
Site Reference ID/Investigator# 34826
Essen, Germany, D-45239
Site Reference ID/Investigator# 53165
Euskirchen, Germany, 53879
Site Reference ID/Investigator# 34836
Frankfurt, Germany, 60318
Site Reference ID/Investigator# 34850
Frankfurt, Germany, 60318
Site Reference ID/Investigator# 34835
Frankfurt, Germany, 60389
Site Reference ID/Investigator# 137296
Freiburg, Germany, 79095
Site Reference ID/Investigator# 34858
Freiburg, Germany, 79098
Site Reference ID/Investigator# 34864
Freital, Germany, 1705
Site Reference ID/Investigator# 114635
Fuerstenzell, Germany, 94081
Site Reference ID/Investigator# 34869
Fuerth, Germany, 90762
Site Reference ID/Investigator# 144063
Fulda, Germany, 36039
Site Reference ID/Investigator# 144060
Gaggenau, Germany, 76571
Site Reference ID/Investigator# 34874
Garbsen, Germany, 30827
Site Reference ID/Investigator# 34875
Gardelegen, Germany, 39638
Site Reference ID/Investigator# 34876
Garmisch-Partenkirchen, Germany, 82467
Site Reference ID/Investigator# 73844
Gedern, Germany, 63688
Site Reference ID/Investigator# 137333
Geldern, Germany, 47608
Site Reference ID/Investigator# 99801
Germering, Germany, 82110
Site Reference ID/Investigator# 58750
Gifhorn, Germany, 38518
Site Reference ID/Investigator# 53202
Gilching, Germany, 82205
Site Reference ID/Investigator# 137360
Gilching, Germany
Site Reference ID/Investigator# 34891
Goeda, Germany, 2633
Site Reference ID/Investigator# 34892
Goerlitz, Germany, 02827
Site Reference ID/Investigator# 73845
Goettingen, Germany, 37073
Site Reference ID/Investigator# 53204
Grevenbroich, Germany, 41515
Site Reference ID/Investigator# 34909
Gruenstadt, Germany, 67269
Site Reference ID/Investigator# 125627
Hagenow, Germany, 19230
Site Reference ID/Investigator# 34915
Hagen, Germany, 58089
Site Reference ID/Investigator# 34927
Halle, Germany, 06108
Site Reference ID/Investigator# 34917
Halle, Germany, 06114
Site Reference ID/Investigator# 99798
Halle, Germany, 06114
Site Reference ID/Investigator# 34945
Halle, Germany, 06120
Site Reference ID/Investigator# 58756
Halle, Germany, 06120
Site Reference ID/Investigator# 99807
Halle, Germany, 06120
Site Reference ID/Investigator# 34933
Halle, Germany, 6108
Site Reference ID/Investigator# 34934
Halle, Germany, 6110
Site Reference ID/Investigator# 34916
Halle, Germany, 6122
Site Reference ID/Investigator# 35108
Hamburg, Germany, 20148
Site Reference ID/Investigator# 35439
Hamburg, Germany, 20148
Site Reference ID/Investigator# 105655
Hamburg, Germany, 20249
Site Reference ID/Investigator# 34976
Hamburg, Germany, 20249
Site Reference ID/Investigator# 34990
Hamburg, Germany, 20249
Site Reference ID/Investigator# 99802
Hamburg, Germany, 20249
Site Reference ID/Investigator# 58742
Hamburg, Germany, 20354
Site Reference ID/Investigator# 58767
Hamburg, Germany, 21031
Site Reference ID/Investigator# 58772
Hamburg, Germany, 22041
Site Reference ID/Investigator# 58763
Hamburg, Germany, 22081
Site Reference ID/Investigator# 34975
Hamburg, Germany, 22303
Site Reference ID/Investigator# 34948
Hamburg, Germany, 22415
Site Reference ID/Investigator# 34987
Hamburg, Germany, 22587
Site Reference ID/Investigator# 34979
Hamburg, Germany, 22607
Site Reference ID/Investigator# 35002
Hamburg, Germany, 22609
Site Reference ID/Investigator# 35013
Hameln, Germany, 31785
Site Reference ID/Investigator# 35016
Hamm, Germany, 59065
Site Reference ID/Investigator# 99806
Hamm, Germany, 59075
Site Reference ID/Investigator# 33787
Hannover, Germany, 30625
Site Reference ID/Investigator# 35031
Hanover, Germany, 30449
Site Reference ID/Investigator# 67703
Hausham, Germany, 83734
Site Reference ID/Investigator# 67705
Hechingen, Germany, 72379
Site Reference ID/Investigator# 125618
Heidelberg, Germany, 69120
Site Reference ID/Investigator# 144062
Heidelberg, Germany, 69120
Site Reference ID/Investigator# 33814
Heidelberg, Germany, 69120
Site Reference ID/Investigator# 125619
Heidelberg, Germany, 69121
Site Reference ID/Investigator# 81618
Heidenau, Germany, 01809
Site Reference ID/Investigator# 33821
Herne, Germany, 44623
Site Reference ID/Investigator# 33822
Herne, Germany, 44649
Site Reference ID/Investigator# 141565
Hildesheim, Germany, 31135
Site Reference ID/Investigator# 125630
Hof, Germany, 95028
Site Reference ID/Investigator# 64002
Hoyerswerda, Germany, 02977
Site Reference ID/Investigator# 81616
Illingen, Germany, 66557
Site Reference ID/Investigator# 81615
Iserlohn, Germany, 58644
Site Reference ID/Investigator# 33939
Jena Lebeda Ost, Germany, 07747
Site Reference ID/Investigator# 125631
Jena, Germany, 07743
Site Reference ID/Investigator# 53162
Karlsruhe, Germany, 76133
Site Reference ID/Investigator# 35485
Kassel, Germany, 34117
Site Reference ID/Investigator# 35486
Kassel, Germany, 34117
Site Reference ID/Investigator# 33973
Kiel, Germany, 24105
Site Reference ID/Investigator# 48901
Kiel, Germany, 24105
Site Reference ID/Investigator# 33976
Kiel, Germany, D-24105
Site Reference ID/Investigator# 58773
Kirchheim, Germany, 85551
Site Reference ID/Investigator# 53149
Kitzingen, Germany, 97318
Site Reference ID/Investigator# 48897
Koblenz, Germany, 56068
Site Reference ID/Investigator# 48903
Koblenz, Germany, 56068
Site Reference ID/Investigator# 73836
Koblenz, Germany, 56068
Site Reference ID/Investigator# 137337
Kothen (Anhalt), Germany, 06366
Site Reference ID/Investigator# 53275
Krefeld, Germany, 47798
Site Reference ID/Investigator# 91103
Landshut, Germany, 84028
Site Reference ID/Investigator# 34094
Lehrte, Germany, 31275
Site Reference ID/Investigator# 34101
Leipzig, Germany, 04103
Site Reference ID/Investigator# 35127
Leipzig, Germany, 04105
Site Reference ID/Investigator# 58752
Leipzig, Germany, 04129
Site Reference ID/Investigator# 58747
Leverkusen, Germany, 51375
Site Reference ID/Investigator# 73833
Leverkusen, Germany, 51375
Site Reference ID/Investigator# 35128
Ludwigshafen, Germany, 67071
Site Reference ID/Investigator# 33409
Luebeck, Germany, 23538
Site Reference ID/Investigator# 34134
Luebeck, Germany, 23552
Site Reference ID/Investigator# 73840
Luebeck, Germany, 23560
Site Reference ID/Investigator# 34140
Lueneburg, Germany, 21339
Site Reference ID/Investigator# 34151
Magdeburg, Germany, 39120
Site Reference ID/Investigator# 34153
Mainz, Germany, 55116
Site Reference ID/Investigator# 125628
Mainz, Germany, 55131
Site Reference ID/Investigator# 64004
Malente, Germany, 23714
Site Reference ID/Investigator# 34181
Mannheim, Germany, 68165
Site Reference ID/Investigator# 64005
Mannheim, Germany, 68167
Site Reference ID/Investigator# 48887
Marburg, Germany, 35037
Site Reference ID/Investigator# 35129
Markkleeberg, Germany, 04416
Site Reference ID/Investigator# 35130
Markkleeberg, Germany, 04416
Site Reference ID/Investigator# 105640
Meitingen, Germany, 86405
Site Reference ID/Investigator# 48904
Meuselwitz, Germany, 04610
Site Reference ID/Investigator# 34204
Minden, Germany, 32423
Site Reference ID/Investigator# 53148
Moenchengladbach, Germany, 41063
Site Reference ID/Investigator# 53163
Moenchengladbach, Germany, 41236
Site Reference ID/Investigator# 53283
Moers, Germany, 47441
Site Reference ID/Investigator# 53154
Moessingen, Germany, 72116
Site Reference ID/Investigator# 114656
Muenster, Germany, 48129
Site Reference ID/Investigator# 48890
Muenster, Germany, 48129
Site Reference ID/Investigator# 35133
Muenster, Germany, 48153
Site Reference ID/Investigator# 35301
Muenster, Germany, 48153
Site Reference ID/Investigator# 99799
Munich, Germany, 80331
Site Reference ID/Investigator# 73839
Munich, Germany, 80539
Site Reference ID/Investigator# 34038
Munich, Germany, 80639
Site Reference ID/Investigator# 53169
Munich, Germany, 81369
Site Reference ID/Investigator# 34033
Munich, Germany, 81373
Site Reference ID/Investigator# 91098
Munich, Germany, 81377
Site Reference ID/Investigator# 105637
Munich, Germany, 81545
Site Reference ID/Investigator# 58744
Munich, Germany, 81669
Site Reference ID/Investigator# 58754
Munich, Germany, 81675
Site Reference ID/Investigator# 81617
Munich, Germany, 81925
Site Reference ID/Investigator# 34045
Munster, Germany, 48159
Site Reference ID/Investigator# 35307
Neubrandenburg, Germany, 17033
Site Reference ID/Investigator# 35308
Neubrandenburg, Germany, 17033
Site Reference ID/Investigator# 114655
Neumuenster, Germany, 24534
Site Reference ID/Investigator# 34069
Neumuenster, Germany, 24534
Site Reference ID/Investigator# 53172
Neuruppin, Germany, 16816
Site Reference ID/Investigator# 34073
Neustadt, Germany, 1844
Site Reference ID/Investigator# 53159
Neuwied, Germany, 56564
Site Reference ID/Investigator# 58769
Neuwied, Germany, 56564
Site Reference ID/Investigator# 34156
Nienburg, Germany, 31582
Site Reference ID/Investigator# 58759
Nienburg, Germany, 31582
Site Reference ID/Investigator# 34162
Nordhausen, Germany, 99734
Site Reference ID/Investigator# 53166
Nuremberg, Germany, 90449
Site Reference ID/Investigator# 51866
Offenburg, Germany, 77652
Site Reference ID/Investigator# 33494
Oldenburg, Germany, 26121
Site Reference ID/Investigator# 48891
Oldenburg, Germany, 26123
Site Reference ID/Investigator# 33500
Osnabrueck, Germany, 49074
Site Reference ID/Investigator# 35331
Osnabrueck, Germany, 49076
Site Reference ID/Investigator# 33498
Osnabrueck, Germany, 49078
Site Reference ID/Investigator# 33501
Paderborn, Germany, 33098
Site Reference ID/Investigator# 33502
Paderborn, Germany, 33098
Site Reference ID/Investigator# 35337
Papenburg, Germany, 26871
Site Reference ID/Investigator# 33525
Plauen, Germany, 8523
Site Reference ID/Investigator# 125617
Pohlheim, Germany, 35415
Site Reference ID/Investigator# 33460
Potsdam, Germany, 14467
Site Reference ID/Investigator# 33463
Potsdam, Germany, 14471
Site Reference ID/Investigator# 105639
Radevormwald, Germany, 42477
Site Reference ID/Investigator# 33489
Recklinghausen, Germany, 45659
Site Reference ID/Investigator# 53344
Regensburg, Germany, 93053
Site Reference ID/Investigator# 58761
Remscheid, Germany, 42859
Site Reference ID/Investigator# 53142
Rinteln, Germany, 31737
Site Reference ID/Investigator# 48886
Rostock, Germany, 18057
Site Reference ID/Investigator# 33924
Rostock, Germany, 18107
Site Reference ID/Investigator# 125620
Rotenburg, Germany, 27356
Site Reference ID/Investigator# 33928
Rotenburg, Germany, 27356
Site Reference ID/Investigator# 33932
Rottenburg, Germany, 72108
Site Reference ID/Investigator# 34012
Ruedersdorf, Germany, 15562
Site Reference ID/Investigator# 137358
Saarbrucken, Germany, 66121
Site Reference ID/Investigator# 91113
Saarbruecken, Germany, 66111
Site Reference ID/Investigator# 145595
Sankt Augustin, Germany, 53757
Site Reference ID/Investigator# 91115
Sauerlach, Germany, 82054
Site Reference ID/Investigator# 73838
Schleswig, Germany, 24837
Site Reference ID/Investigator# 34029
Schmalkalden, Germany, 98574
Site Reference ID/Investigator# 48892
Schwalmstadt, Germany, 34613
Site Reference ID/Investigator# 35137
Schwarz, Germany, 17252
Site Reference ID/Investigator# 33545
Schweinfurt, Germany, 97421
Site Reference ID/Investigator# 33551
Schwerin, Germany, 19053
Site Reference ID/Investigator# 58760
Solingen, Germany, 42651
Site Reference ID/Investigator# 137359
Speyer, Germany, 67346
Site Reference ID/Investigator# 33581
Stade, Germany, 21682
Site Reference ID/Investigator# 53286
Stade, Germany, 21682
Site Reference ID/Investigator# 33593
Stralsund, Germany, 18439
Site Reference ID/Investigator# 48896
Strausberg, Germany, 15344
Site Reference ID/Investigator# 48894
Stuhr, Germany, 28816
Site Reference ID/Investigator# 35385
Stuttgart, Germany, 70176
Site Reference ID/Investigator# 33599
Stuttgart, Germany, 70565
Site Reference ID/Investigator# 53263
Stuttgart, Germany, 70565
Site Reference ID/Investigator# 33612
Stuttgart, Germany, D-70376
Site Reference ID/Investigator# 91114
Teuchern, Germany, 06682
Site Reference ID/Investigator# 58753
Traunstein, Germany, 83278
Site Reference ID/Investigator# 125621
Tuebingen, Germany, 72076
Site Reference ID/Investigator# 33630
Tuebingen, Germany, 72076
Site Reference ID/Investigator# 34177
Tuebingen, Germany, 72076
Site Reference ID/Investigator# 73848
Tutzing, Germany, 82327
Site Reference ID/Investigator# 48893
Uelzen, Germany, 29525
Site Reference ID/Investigator# 58771
Ulm, Germany, 89073
Site Reference ID/Investigator# 33726
Ulm, Germany, 89081
Site Reference ID/Investigator# 53164
Urbach, Germany, 73660
Site Reference ID/Investigator# 33731
Vechta, Germany, 49377
Site Reference ID/Investigator# 53251
Vilshofen, Germany, 94474
Site Reference ID/Investigator# 33744
Waren, Germany, 17192
Site Reference ID/Investigator# 53287
Weilheim, Germany, 82362
Site Reference ID/Investigator# 33763
Wiesbaden, Germany, 65185
Site Reference ID/Investigator# 48889
Wiesbaden, Germany, 65189
Site Reference ID/Investigator# 33769
Wilhelmshaven, Germany, 26382
Site Reference ID/Investigator# 53146
Wittenberge, Germany, 19322
Site Reference ID/Investigator# 67704
Witten, Germany, 58452
Site Reference ID/Investigator# 35083
Wriezen, Germany, 16269
Site Reference ID/Investigator# 73849
Wuerselen, Germany, 52146
Site Reference ID/Investigator# 81619
Wuerselen, Germany, 52146
Site Reference ID/Investigator# 33719
Wuerzburg, Germany, 97080
Site Reference ID/Investigator# 33868
Zittau, Germany, 2763
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Bianca Wittig, MD AbbVie Deutschland GmbH & Co. KG, Medical Department
  More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01083680     History of Changes
Other Study ID Numbers: P10-278 
Study First Received: February 26, 2010
Last Updated: January 25, 2016
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by AbbVie:
Routine clinical setting
Long-term efficacy and safety
Crohn's Disease
Humira

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 25, 2016