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

This study is currently recruiting participants.
Verified May 2013 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01083680
First received: February 26, 2010
Last updated: May 21, 2013
Last verified: May 2013
  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 Intervention
Crohn´s Disease
Biological: adalimumab (Humira)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Long-time Documentation of the Safety and Efficacy of HUMIRA in Patients With Sever Active Crohn's Disease

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 ] [ Designated as safety issue: Yes ]
  • Compliance with the self-injection via the HUMIRA-PEN, [ Time Frame: Months 0, 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: No ]
  • Rate of adverse events [ Time Frame: Months 0, 3, 6, 9, 12, 18, 24 ] [ Designated as safety issue: Yes ]
  • Long-term improvement of patients Quality of Life [ Time Frame: Months 0, 3, 6, 12, 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 2500
Study Start Date: June 2007
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Crohn's Disease patients
Patients with Crohn's Disease
Biological: adalimumab (Humira)
In week 0: 80 mg adalimumab (Humira), week 2: 40 mg adalimumab (Humira), followed by 40 mg every other week.
Other Name: Humira-PEN

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 and older
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01083680

Contacts
Contact: Gerd Greger, PhD +49 6122 58-1610 gerd.greger@abbvie.com
Contact: Elisabeth Glaser-Caldow #49 6122 581235 elisabeth.glaser@abbvie.com

  Hide Study Locations
Locations
Germany
Site Reference ID/Investigator# 58770 Recruiting
Aachen, Germany, 52074
Principal Investigator: Site Reference ID/Investigator# 58770            
Site Reference ID/Investigator# 91100 Recruiting
Aichhalden, Germany, 78733
Principal Investigator: Site Reference ID/Investigator# 91100            
Site Reference ID/Investigator# 48900 Recruiting
Altenburg, Germany, 04600
Principal Investigator: Site Reference ID/Investigator# 48900            
Site Reference ID/Investigator# 64006 Recruiting
Altenholz, Germany, 24161
Principal Investigator: Site Reference ID/Investigator# 64006            
Site Reference ID/Investigator# 35047 Recruiting
Alzey, Germany, 55232
Principal Investigator: Site Reference ID/Investigator# 35047            
Site Reference ID/Investigator# 35062 Recruiting
Augsburg, Germany, 86150
Principal Investigator: Site Reference ID/Investigator# 35062            
Site Reference ID/Investigator# 48899 Recruiting
Bad Berka, Germany, 99438
Principal Investigator: Site Reference ID/Investigator# 48899            
Site Reference ID/Investigator# 58751 Recruiting
Bad Homburg, Germany, 61348
Principal Investigator: Site Reference ID/Investigator# 58751            
Site Reference ID/Investigator# 67702 Recruiting
Bad Homburg, Germany, 61348
Principal Investigator: Site Reference ID/Investigator# 67702            
Site Reference ID/Investigator# 48888 Recruiting
Bad Lausick, Germany, 04651
Principal Investigator: Site Reference ID/Investigator# 48888            
Site Reference ID/Investigator# 53216 Recruiting
Bad Salzungen, Germany, 36433
Principal Investigator: Site Reference ID/Investigator# 53216            
Site Reference ID/Investigator# 73842 Recruiting
Bad Wildungen, Germany, 34537
Principal Investigator: Site Reference ID/Investigator# 73842            
Site Reference ID/Investigator# 91099 Recruiting
Baden-Baden, Germany, 76530
Principal Investigator: Site Reference ID/Investigator# 91099            
Site Reference ID/Investigator# 73847 Recruiting
Baden-Baden, Germany, 76530
Principal Investigator: Site Reference ID/Investigator# 73847            
Site Reference ID/Investigator# 53217 Recruiting
Bayreuth, Germany, 95444
Principal Investigator: Site Reference ID/Investigator# 53217            
Site Reference ID/Investigator# 33443 Recruiting
Bayreuth, Germany, 95444
Principal Investigator: Site Reference ID/Investigator# 33443            
Site Reference ID/Investigator# 6070 Recruiting
Berlin, Germany, 13353
Principal Investigator: Site Reference ID/Investigator# 6070            
Site Reference ID/Investigator# 73846 Recruiting
Berlin, Germany, 12437
Principal Investigator: Site Reference ID/Investigator# 73846            
Site Reference ID/Investigator# 34240 Recruiting
Berlin, Germany, 10713
Principal Investigator: Site Reference ID/Investigator# 34240            
Site Reference ID/Investigator# 33455 Recruiting
Berlin, Germany, 12200
Principal Investigator: Site Reference ID/Investigator# 33455            
Site Reference ID/Investigator# 91101 Recruiting
Berlin, Germany, 12619
Principal Investigator: Site Reference ID/Investigator# 91101            
Site Reference ID/Investigator# 33701 Recruiting
Berlin, Germany, 10437
Principal Investigator: Site Reference ID/Investigator# 33701            
Site Reference ID/Investigator# 33645 Recruiting
Berlin, Germany, 13437
Principal Investigator: Site Reference ID/Investigator# 33645            
Site Reference ID/Investigator# 33663 Recruiting
Berlin, Germany, 10367
Principal Investigator: Site Reference ID/Investigator# 33663            
Site Reference ID/Investigator# 33671 Recruiting
Berlin, Germany, 10825
Principal Investigator: Site Reference ID/Investigator# 33671            
Site Reference ID/Investigator# 33679 Recruiting
Berlin, Germany, 10318
Principal Investigator: Site Reference ID/Investigator# 33679            
Site Reference ID/Investigator# 33684 Recruiting
Berlin, Germany, 12619
Principal Investigator: Site Reference ID/Investigator# 33684            
Site Reference ID/Investigator# 33698 Recruiting
Berlin, Germany, 10117
Principal Investigator: Site Reference ID/Investigator# 33698            
Site Reference ID/Investigator# 33699 Recruiting
Berlin, Germany, 10825
Principal Investigator: Site Reference ID/Investigator# 33699            
Site Reference ID/Investigator# 33700 Recruiting
Berlin, Germany, 10249
Principal Investigator: Site Reference ID/Investigator# 33700            
Site Reference ID/Investigator# 33706 Recruiting
Berlin, Germany, 13086
Principal Investigator: Site Reference ID/Investigator# 33706            
Site Reference ID/Investigator# 34244 Recruiting
Berlin, Germany, 10719
Principal Investigator: Site Reference ID/Investigator# 34244            
Site Reference ID/Investigator# 58764 Recruiting
Berlin, Germany, 13125
Principal Investigator: Site Reference ID/Investigator# 58764            
Site Reference ID/Investigator# 34242 Recruiting
Berlin, Germany, 10437
Principal Investigator: Site Reference ID/Investigator# 34242            
Site Reference ID/Investigator# 58758 Recruiting
Berlin, Germany, 10825
Principal Investigator: Site Reference ID/Investigator# 58758            
Site Reference ID/Investigator# 48883 Recruiting
Berlin, Germany, 10117
Principal Investigator: Site Reference ID/Investigator# 48883            
Site Reference ID/Investigator# 58749 Recruiting
Berlin, Germany, 12621
Principal Investigator: Site Reference ID/Investigator# 58749            
Site Reference ID/Investigator# 34248 Recruiting
Berlin, Germany, 14089
Principal Investigator: Site Reference ID/Investigator# 34248            
Site Reference ID/Investigator# 73834 Recruiting
Bernau, Germany, 83233
Principal Investigator: Site Reference ID/Investigator# 73834            
Site Reference ID/Investigator# 105656 Recruiting
Biberach, Germany, 88400
Principal Investigator: Site Reference ID/Investigator# 105656            
Site Reference ID/Investigator# 34278 Recruiting
Bielefeld, Germany, 33609
Principal Investigator: Site Reference ID/Investigator# 34278            
Site Reference ID/Investigator# 73835 Recruiting
Bitburg, Germany, 54634
Principal Investigator: Site Reference ID/Investigator# 73835            
Site Reference ID/Investigator# 34281 Recruiting
Bitterfeld, Germany, 6749
Principal Investigator: Site Reference ID/Investigator# 34281            
Site Reference ID/Investigator# 58765 Recruiting
Bochum, Germany, 44787
Principal Investigator: Site Reference ID/Investigator# 58765            
Site Reference ID/Investigator# 53237 Recruiting
Bonn, Germany, 53173
Principal Investigator: Site Reference ID/Investigator# 53237            
Site Reference ID/Investigator# 73843 Recruiting
Bonn, Germany, 53111
Principal Investigator: Site Reference ID/Investigator# 73843            
Site Reference ID/Investigator# 53273 Recruiting
Bonn, Germany, 53115
Principal Investigator: Site Reference ID/Investigator# 53273            
Site Reference ID/Investigator# 53253 Recruiting
Bonn, Germany, 53225
Principal Investigator: Site Reference ID/Investigator# 53253            
Site Reference ID/Investigator# 34304 Recruiting
Brandenburg, Germany, 14776
Principal Investigator: Site Reference ID/Investigator# 34304            
Site Reference ID/Investigator# 35654 Recruiting
Braunschweig, Germany, 38100
Principal Investigator: Site Reference ID/Investigator# 35654            
Site Reference ID/Investigator# 48902 Recruiting
Bremen, Germany, 28259
Principal Investigator: Site Reference ID/Investigator# 48902            
Site Reference ID/Investigator# 105638 Recruiting
Bremerhaven, Germany, 27570
Principal Investigator: Site Reference ID/Investigator# 105638            
Site Reference ID/Investigator# 34690 Recruiting
Bremervoerde, Germany, 27432
Principal Investigator: Site Reference ID/Investigator# 34690            
Site Reference ID/Investigator# 48884 Recruiting
Buchholz, Germany, 21244
Principal Investigator: Site Reference ID/Investigator# 48884            
Site Reference ID/Investigator# 34693 Recruiting
Buende, Germany, 32257
Principal Investigator: Site Reference ID/Investigator# 34693            
Site Reference ID/Investigator# 53178 Recruiting
Buende, Germany, 32257
Principal Investigator: Site Reference ID/Investigator# 53178            
Site Reference ID/Investigator# 53282 Recruiting
Burglengenfeld, Germany, 93133
Principal Investigator: Site Reference ID/Investigator# 53282            
Site Reference ID/Investigator# 53143 Recruiting
Chemnitz, Germany, 09130
Principal Investigator: Site Reference ID/Investigator# 53143            
Site Reference ID/Investigator# 34701 Recruiting
Chemnitz, Germany, 9126
Principal Investigator: Site Reference ID/Investigator# 34701            
Site Reference ID/Investigator# 34702 Recruiting
Chemnitz, Germany, 9127
Principal Investigator: Site Reference ID/Investigator# 34702            
Site Reference ID/Investigator# 34705 Recruiting
Coburg, Germany, 96450
Principal Investigator: Site Reference ID/Investigator# 34705            
Site Reference ID/Investigator# 34706 Recruiting
Coesfeld, Germany, 48653
Principal Investigator: Site Reference ID/Investigator# 34706            
Site Reference ID/Investigator# 53152 Recruiting
Coesfeld, Germany, 48653
Principal Investigator: Site Reference ID/Investigator# 53152            
Site Reference ID/Investigator# 53124 Recruiting
Cologne, Germany, 51063
Principal Investigator: Site Reference ID/Investigator# 53124            
Site Reference ID/Investigator# 53342 Recruiting
Cottbus, Germany, 03046
Principal Investigator: Site Reference ID/Investigator# 53342            
Site Reference ID/Investigator# 34714 Recruiting
Cottbus, Germany, 3048
Principal Investigator: Site Reference ID/Investigator# 34714            
Site Reference ID/Investigator# 34713 Recruiting
Cottbus, Germany, 3048
Principal Investigator: Site Reference ID/Investigator# 34713            
Site Reference ID/Investigator# 53285 Recruiting
Dachau, Germany, 85221
Principal Investigator: Site Reference ID/Investigator# 53285            
Site Reference ID/Investigator# 35624 Recruiting
Darmstadt, Germany, 64293
Principal Investigator: Site Reference ID/Investigator# 35624            
Site Reference ID/Investigator# 53157 Recruiting
Darmstadt, Germany, 64287
Principal Investigator: Site Reference ID/Investigator# 53157            
Site Reference ID/Investigator# 35623 Recruiting
Darmstadt, Germany, 64293
Principal Investigator: Site Reference ID/Investigator# 35623            
Site Reference ID/Investigator# 34719 Recruiting
Darmstadt, Germany, 64283
Principal Investigator: Site Reference ID/Investigator# 34719            
Site Reference ID/Investigator# 34721 Recruiting
Datteln, Germany, 45711
Principal Investigator: Site Reference ID/Investigator# 34721            
Site Reference ID/Investigator# 58776 Recruiting
Detmold, Germany, 32756
Principal Investigator: Site Reference ID/Investigator# 58776            
Site Reference ID/Investigator# 34732 Recruiting
Dingolfing, Germany, 84130
Principal Investigator: Site Reference ID/Investigator# 34732            
Site Reference ID/Investigator# 34733 Recruiting
Dinkelsbuehl, Germany, 91550
Principal Investigator: Site Reference ID/Investigator# 34733            
Site Reference ID/Investigator# 34735 Recruiting
Dippoldiswalde, Germany, 1744
Principal Investigator: Site Reference ID/Investigator# 34735            
Site Reference ID/Investigator# 34743 Recruiting
Dortmund, Germany, 44263
Principal Investigator: Site Reference ID/Investigator# 34743            
Site Reference ID/Investigator# 35638 Recruiting
Dresden, Germany, 1307
Principal Investigator: Site Reference ID/Investigator# 35638            
Site Reference ID/Investigator# 34757 Recruiting
Dresden, Germany, 1279
Principal Investigator: Site Reference ID/Investigator# 34757            
Site Reference ID/Investigator# 34745 Recruiting
Dresden, Germany, 1309
Principal Investigator: Site Reference ID/Investigator# 34745            
Site Reference ID/Investigator# 34761 Recruiting
Dresden, Germany, 01067
Principal Investigator: Site Reference ID/Investigator# 34761            
Site Reference ID/Investigator# 73841 Recruiting
Dresden, Germany, 01069
Principal Investigator: Site Reference ID/Investigator# 73841            
Site Reference ID/Investigator# 34770 Recruiting
Duesseldorf, Germany, 40237
Principal Investigator: Site Reference ID/Investigator# 34770            
Site Reference ID/Investigator# 48895 Recruiting
Ebern, Germany, 96106
Principal Investigator: Site Reference ID/Investigator# 48895            
Site Reference ID/Investigator# 99800 Recruiting
Eichstaett, Germany, 85072
Principal Investigator: Site Reference ID/Investigator# 99800            
Site Reference ID/Investigator# 48898 Recruiting
Eisenach, Germany, 99817
Principal Investigator: Site Reference ID/Investigator# 48898            
Site Reference ID/Investigator# 34791 Recruiting
Ellefeld, Germany, 8236
Principal Investigator: Site Reference ID/Investigator# 34791            
Site Reference ID/Investigator# 34798 Recruiting
Emden, Germany, 26721
Principal Investigator: Site Reference ID/Investigator# 34798            
Site Reference ID/Investigator# 34806 Recruiting
Erfurt, Germany, 99084
Principal Investigator: Site Reference ID/Investigator# 34806            
Site Reference ID/Investigator# 35192 Recruiting
Erlangen, Germany, 91052
Principal Investigator: Site Reference ID/Investigator# 35192            
Site Reference ID/Investigator# 34819 Recruiting
Erlangen, Germany, D-91054
Principal Investigator: Site Reference ID/Investigator# 34819            
Site Reference ID/Investigator# 34818 Recruiting
Erlangen, Germany, D-91054
Principal Investigator: Site Reference ID/Investigator# 34818            
Site Reference ID/Investigator# 34822 Recruiting
Eschweiler, Germany, 52249
Principal Investigator: Site Reference ID/Investigator# 34822            
Site Reference ID/Investigator# 91102 Recruiting
Essen, Germany, 45147
Principal Investigator: Site Reference ID/Investigator# 91102            
Site Reference ID/Investigator# 34826 Recruiting
Essen, Germany, D-45239
Principal Investigator: Site Reference ID/Investigator# 34826            
Site Reference ID/Investigator# 53168 Recruiting
Essen, Germany, 45138
Principal Investigator: Site Reference ID/Investigator# 53168            
Site Reference ID/Investigator# 53165 Recruiting
Euskirchen, Germany, 53879
Principal Investigator: Site Reference ID/Investigator# 53165            
Site Reference ID/Investigator# 34835 Recruiting
Frankfurt, Germany, 60389
Principal Investigator: Site Reference ID/Investigator# 34835            
Site Reference ID/Investigator# 34836 Recruiting
Frankfurt, Germany, 60318
Principal Investigator: Site Reference ID/Investigator# 34836            
Site Reference ID/Investigator# 34850 Recruiting
Frankfurt, Germany, 60318
Principal Investigator: Site Reference ID/Investigator# 34850            
Site Reference ID/Investigator# 34862 Recruiting
Freiburg, Germany, D-79106
Principal Investigator: Site Reference ID/Investigator# 34862            
Site Reference ID/Investigator# 34858 Recruiting
Freiburg, Germany, 79098
Principal Investigator: Site Reference ID/Investigator# 34858            
Site Reference ID/Investigator# 34864 Recruiting
Freital, Germany, 1705
Principal Investigator: Site Reference ID/Investigator# 34864            
Site Reference ID/Investigator# 34869 Recruiting
Fuerth, Germany, 90762
Principal Investigator: Site Reference ID/Investigator# 34869            
Site Reference ID/Investigator# 34874 Recruiting
Garbsen, Germany, 30827
Principal Investigator: Site Reference ID/Investigator# 34874            
Site Reference ID/Investigator# 34875 Recruiting
Gardelegen, Germany, 39638
Principal Investigator: Site Reference ID/Investigator# 34875            
Site Reference ID/Investigator# 34876 Recruiting
Garmisch-Partenkirchen, Germany, 82467
Principal Investigator: Site Reference ID/Investigator# 34876            
Site Reference ID/Investigator# 73844 Recruiting
Gedern, Germany, 63688
Principal Investigator: Site Reference ID/Investigator# 73844            
Site Reference ID/Investigator# 99801 Recruiting
Germering, Germany, 82110
Principal Investigator: Site Reference ID/Investigator# 99801            
Site Reference ID/Investigator# 58750 Recruiting
Gifhorn, Germany, 38518
Principal Investigator: Site Reference ID/Investigator# 58750            
Site Reference ID/Investigator# 53202 Recruiting
Gilching, Germany, 82205
Principal Investigator: Site Reference ID/Investigator# 53202            
Site Reference ID/Investigator# 34891 Recruiting
Goeda, Germany, 2633
Principal Investigator: Site Reference ID/Investigator# 34891            
Site Reference ID/Investigator# 34892 Recruiting
Goerlitz, Germany, 02827
Principal Investigator: Site Reference ID/Investigator# 34892            
Site Reference ID/Investigator# 73845 Recruiting
Goettingen, Germany, 37073
Principal Investigator: Site Reference ID/Investigator# 73845            
Site Reference ID/Investigator# 53204 Recruiting
Grevenbroich, Germany, 41515
Principal Investigator: Site Reference ID/Investigator# 53204            
Site Reference ID/Investigator# 34909 Recruiting
Gruenstadt, Germany, 67269
Principal Investigator: Site Reference ID/Investigator# 34909            
Site Reference ID/Investigator# 34915 Recruiting
Hagen, Germany, 58089
Principal Investigator: Site Reference ID/Investigator# 34915            
Site Reference ID/Investigator# 34934 Recruiting
Halle, Germany, 6110
Principal Investigator: Site Reference ID/Investigator# 34934            
Site Reference ID/Investigator# 58756 Recruiting
Halle, Germany, 06120
Principal Investigator: Site Reference ID/Investigator# 58756            
Site Reference ID/Investigator# 99807 Recruiting
Halle, Germany, 06120
Principal Investigator: Site Reference ID/Investigator# 99807            
Site Reference ID/Investigator# 34933 Recruiting
Halle, Germany, 6108
Principal Investigator: Site Reference ID/Investigator# 34933            
Site Reference ID/Investigator# 99798 Recruiting
Halle, Germany, 06114
Principal Investigator: Site Reference ID/Investigator# 99798            
Site Reference ID/Investigator# 34927 Recruiting
Halle, Germany, 06108
Principal Investigator: Site Reference ID/Investigator# 34927            
Site Reference ID/Investigator# 34916 Recruiting
Halle, Germany, 6122
Principal Investigator: Site Reference ID/Investigator# 34916            
Site Reference ID/Investigator# 35002 Recruiting
Hamburg, Germany, 22609
Principal Investigator: Site Reference ID/Investigator# 35002            
Site Reference ID/Investigator# 34987 Recruiting
Hamburg, Germany, 22587
Principal Investigator: Site Reference ID/Investigator# 34987            
Site Reference ID/Investigator# 34979 Recruiting
Hamburg, Germany, 22607
Principal Investigator: Site Reference ID/Investigator# 34979            
Site Reference ID/Investigator# 34978 Recruiting
Hamburg, Germany, 22081
Principal Investigator: Site Reference ID/Investigator# 34978            
Site Reference ID/Investigator# 34990 Recruiting
Hamburg, Germany, 20249
Principal Investigator: Site Reference ID/Investigator# 34990            
Site Reference ID/Investigator# 34976 Recruiting
Hamburg, Germany, 20249
Principal Investigator: Site Reference ID/Investigator# 34976            
Site Reference ID/Investigator# 34975 Recruiting
Hamburg, Germany, 22303
Principal Investigator: Site Reference ID/Investigator# 34975            
Site Reference ID/Investigator# 34948 Recruiting
Hamburg, Germany, 22415
Principal Investigator: Site Reference ID/Investigator# 34948            
Site Reference ID/Investigator# 35108 Recruiting
Hamburg, Germany, 20148
Principal Investigator: Site Reference ID/Investigator# 35108            
Site Reference ID/Investigator# 73837 Recruiting
Hamburg, Germany, 21073
Principal Investigator: Site Reference ID/Investigator# 73837            
Site Reference ID/Investigator# 35439 Recruiting
Hamburg, Germany, 20148
Principal Investigator: Site Reference ID/Investigator# 35439            
Site Reference ID/Investigator# 58767 Recruiting
Hamburg, Germany, 21031
Principal Investigator: Site Reference ID/Investigator# 58767            
Site Reference ID/Investigator# 99802 Recruiting
Hamburg, Germany, 20249
Principal Investigator: Site Reference ID/Investigator# 99802            
Site Reference ID/Investigator# 58763 Recruiting
Hamburg, Germany, 22081
Principal Investigator: Site Reference ID/Investigator# 58763            
Site Reference ID/Investigator# 58742 Recruiting
Hamburg, Germany, 20354
Principal Investigator: Site Reference ID/Investigator# 58742            
Site Reference ID/Investigator# 105655 Recruiting
Hamburg, Germany, 20249
Principal Investigator: Site Reference ID/Investigator# 105655            
Site Reference ID/Investigator# 58772 Recruiting
Hamburg, Germany, 22041
Principal Investigator: Site Reference ID/Investigator# 58772            
Site Reference ID/Investigator# 35013 Recruiting
Hameln, Germany, 31785
Principal Investigator: Site Reference ID/Investigator# 35013            
Site Reference ID/Investigator# 35016 Recruiting
Hamm, Germany, 59065
Principal Investigator: Site Reference ID/Investigator# 35016            
Site Reference ID/Investigator# 99806 Recruiting
Hamm, Germany, 59075
Principal Investigator: Site Reference ID/Investigator# 99806            
Site Reference ID/Investigator# 33787 Recruiting
Hannover, Germany, 30625
Principal Investigator: Site Reference ID/Investigator# 33787            
Site Reference ID/Investigator# 53145 Recruiting
Hanover, Germany, 30625
Principal Investigator: Site Reference ID/Investigator# 53145            
Site Reference ID/Investigator# 35031 Recruiting
Hanover, Germany, 30449
Principal Investigator: Site Reference ID/Investigator# 35031            
Site Reference ID/Investigator# 67703 Recruiting
Hausham, Germany, 83734
Principal Investigator: Site Reference ID/Investigator# 67703            
Site Reference ID/Investigator# 67705 Recruiting
Hechingen, Germany, 72379
Principal Investigator: Site Reference ID/Investigator# 67705            
Site Reference ID/Investigator# 48885 Recruiting
Heidelberg, Germany, 69120
Principal Investigator: Site Reference ID/Investigator# 48885            
Site Reference ID/Investigator# 33814 Recruiting
Heidelberg, Germany, 69120
Principal Investigator: Site Reference ID/Investigator# 33814            
Site Reference ID/Investigator# 81618 Recruiting
Heidenau, Germany, 01809
Principal Investigator: Site Reference ID/Investigator# 81618            
Site Reference ID/Investigator# 33821 Recruiting
Herne, Germany, 44623
Principal Investigator: Site Reference ID/Investigator# 33821            
Site Reference ID/Investigator# 33822 Recruiting
Herne, Germany, 44649
Principal Investigator: Site Reference ID/Investigator# 33822            
Site Reference ID/Investigator# 35473 Recruiting
Hildesheim, Germany, 31135
Principal Investigator: Site Reference ID/Investigator# 35473            
Site Reference ID/Investigator# 64002 Recruiting
Hoyerswerda, Germany, 02977
Principal Investigator: Site Reference ID/Investigator# 64002            
Site Reference ID/Investigator# 81616 Recruiting
Illingen, Germany, 66557
Principal Investigator: Site Reference ID/Investigator# 81616            
Site Reference ID/Investigator# 81615 Recruiting
Iserlohn, Germany, 58644
Principal Investigator: Site Reference ID/Investigator# 81615            
Site Reference ID/Investigator# 33939 Recruiting
Jena Lebeda Ost, Germany, 07747
Principal Investigator: Site Reference ID/Investigator# 33939            
Site Reference ID/Investigator# 53162 Recruiting
Karlsruhe, Germany, 76133
Principal Investigator: Site Reference ID/Investigator# 53162            
Site Reference ID/Investigator# 35486 Recruiting
Kassel, Germany, 34117
Principal Investigator: Site Reference ID/Investigator# 35486            
Site Reference ID/Investigator# 35485 Recruiting
Kassel, Germany, 34117
Principal Investigator: Site Reference ID/Investigator# 35485            
Site Reference ID/Investigator# 48901 Recruiting
Kiel, Germany, 24105
Principal Investigator: Site Reference ID/Investigator# 48901            
Site Reference ID/Investigator# 33976 Recruiting
Kiel, Germany, D-24105
Principal Investigator: Site Reference ID/Investigator# 33976            
Site Reference ID/Investigator# 33973 Recruiting
Kiel, Germany, 24105
Principal Investigator: Site Reference ID/Investigator# 33973            
Site Reference ID/Investigator# 58773 Recruiting
Kirchheim, Germany, 85551
Principal Investigator: Site Reference ID/Investigator# 58773            
Site Reference ID/Investigator# 53149 Recruiting
Kitzingen, Germany, 97318
Principal Investigator: Site Reference ID/Investigator# 53149            
Site Reference ID/Investigator# 48897 Recruiting
Koblenz, Germany, 56068
Principal Investigator: Site Reference ID/Investigator# 48897            
Site Reference ID/Investigator# 73836 Recruiting
Koblenz, Germany, 56068
Principal Investigator: Site Reference ID/Investigator# 73836            
Site Reference ID/Investigator# 48903 Recruiting
Koblenz, Germany, 56068
Principal Investigator: Site Reference ID/Investigator# 48903            
Site Reference ID/Investigator# 53275 Recruiting
Krefeld, Germany, 47798
Principal Investigator: Site Reference ID/Investigator# 53275            
Site Reference ID/Investigator# 91103 Recruiting
Landshut, Germany, 84028
Principal Investigator: Site Reference ID/Investigator# 91103            
Site Reference ID/Investigator# 34094 Recruiting
Lehrte, Germany, 31275
Principal Investigator: Site Reference ID/Investigator# 34094            
Site Reference ID/Investigator# 34101 Recruiting
Leipzig, Germany, 04103
Principal Investigator: Site Reference ID/Investigator# 34101            
Site Reference ID/Investigator# 35127 Recruiting
Leipzig, Germany, 04105
Principal Investigator: Site Reference ID/Investigator# 35127            
Site Reference ID/Investigator# 58752 Recruiting
Leipzig, Germany, 04129
Principal Investigator: Site Reference ID/Investigator# 58752            
Site Reference ID/Investigator# 73833 Recruiting
Leverkusen, Germany, 51375
Principal Investigator: Site Reference ID/Investigator# 73833            
Site Reference ID/Investigator# 58747 Recruiting
Leverkusen, Germany, 51375
Principal Investigator: Site Reference ID/Investigator# 58747            
Site Reference ID/Investigator# 34134 Recruiting
Luebeck, Germany, 23552
Principal Investigator: Site Reference ID/Investigator# 34134            
Site Reference ID/Investigator# 33409 Recruiting
Luebeck, Germany, 23538
Principal Investigator: Site Reference ID/Investigator# 33409            
Site Reference ID/Investigator# 73840 Recruiting
Luebeck, Germany, 23560
Principal Investigator: Site Reference ID/Investigator# 73840            
Site Reference ID/Investigator# 34140 Recruiting
Lueneburg, Germany, 21339
Principal Investigator: Site Reference ID/Investigator# 34140            
Site Reference ID/Investigator# 34151 Recruiting
Magdeburg, Germany, 39120
Principal Investigator: Site Reference ID/Investigator# 34151            
Site Reference ID/Investigator# 34153 Recruiting
Mainz, Germany, 55116
Principal Investigator: Site Reference ID/Investigator# 34153            
Site Reference ID/Investigator# 34177 Recruiting
Mainz, Germany, 55131
Principal Investigator: Site Reference ID/Investigator# 34177            
Site Reference ID/Investigator# 64004 Recruiting
Malente, Germany, 23714
Principal Investigator: Site Reference ID/Investigator# 64004            
Site Reference ID/Investigator# 64005 Recruiting
Mannheim, Germany, 68167
Principal Investigator: Site Reference ID/Investigator# 64005            
Site Reference ID/Investigator# 34181 Recruiting
Mannheim, Germany, 68165
Principal Investigator: Site Reference ID/Investigator# 34181            
Site Reference ID/Investigator# 35128 Recruiting
Mannheim, Germany, 68161
Principal Investigator: Site Reference ID/Investigator# 35128            
Site Reference ID/Investigator# 48887 Recruiting
Marburg, Germany, 35037
Principal Investigator: Site Reference ID/Investigator# 48887            
Site Reference ID/Investigator# 35130 Recruiting
Markkleeberg, Germany, 04416
Principal Investigator: Site Reference ID/Investigator# 35130            
Site Reference ID/Investigator# 35129 Recruiting
Markkleeberg, Germany, 04416
Principal Investigator: Site Reference ID/Investigator# 35129            
Site Reference ID/Investigator# 105640 Recruiting
Meitingen, Germany, 86405
Principal Investigator: Site Reference ID/Investigator# 105640            
Site Reference ID/Investigator# 48904 Recruiting
Meuselwitz, Germany, 04610
Principal Investigator: Site Reference ID/Investigator# 48904            
Site Reference ID/Investigator# 34204 Recruiting
Minden, Germany, 32423
Principal Investigator: Site Reference ID/Investigator# 34204            
Site Reference ID/Investigator# 53148 Recruiting
Moenchengladbach, Germany, 41063
Principal Investigator: Site Reference ID/Investigator# 53148            
Site Reference ID/Investigator# 53163 Recruiting
Moenchengladbach, Germany, 41236
Principal Investigator: Site Reference ID/Investigator# 53163            
Site Reference ID/Investigator# 53283 Recruiting
Moers, Germany, 47441
Principal Investigator: Site Reference ID/Investigator# 53283            
Site Reference ID/Investigator# 53154 Recruiting
Moessingen, Germany, 72116
Principal Investigator: Site Reference ID/Investigator# 53154            
Site Reference ID/Investigator# 48890 Recruiting
Muenster, Germany, 48129
Principal Investigator: Site Reference ID/Investigator# 48890            
Site Reference ID/Investigator# 99804 Recruiting
Muenster, Germany, 48129
Principal Investigator: Site Reference ID/Investigator# 99804            
Site Reference ID/Investigator# 35133 Recruiting
Muenster, Germany, 48153
Principal Investigator: Site Reference ID/Investigator# 35133            
Site Reference ID/Investigator# 34045 Recruiting
Muenster, Germany, 48159
Principal Investigator: Site Reference ID/Investigator# 34045            
Site Reference ID/Investigator# 35301 Recruiting
Muenster, Germany, 48153
Principal Investigator: Site Reference ID/Investigator# 35301            
Site Reference ID/Investigator# 58744 Recruiting
Munich, Germany, 81669
Principal Investigator: Site Reference ID/Investigator# 58744            
Site Reference ID/Investigator# 73839 Recruiting
Munich, Germany, 80539
Principal Investigator: Site Reference ID/Investigator# 73839            
Site Reference ID/Investigator# 53169 Recruiting
Munich, Germany, 81369
Principal Investigator: Site Reference ID/Investigator# 53169            
Site Reference ID/Investigator# 81617 Recruiting
Munich, Germany, 81925
Principal Investigator: Site Reference ID/Investigator# 81617            
Site Reference ID/Investigator# 99803 Recruiting
Munich, Germany, 80331
Principal Investigator: Site Reference ID/Investigator# 99803            
Site Reference ID/Investigator# 34038 Recruiting
Munich, Germany, 80639
Principal Investigator: Site Reference ID/Investigator# 34038            
Site Reference ID/Investigator# 91098 Recruiting
Munich, Germany, 81377
Principal Investigator: Site Reference ID/Investigator# 91098            
Site Reference ID/Investigator# 105637 Recruiting
Munich, Germany, 81545
Principal Investigator: Site Reference ID/Investigator# 105637            
Site Reference ID/Investigator# 34033 Recruiting
Munich, Germany, 81373
Principal Investigator: Site Reference ID/Investigator# 34033            
Site Reference ID/Investigator# 58754 Recruiting
Munich, Germany, 81675
Principal Investigator: Site Reference ID/Investigator# 58754            
Site Reference ID/Investigator# 99799 Recruiting
Munich, Germany, 80331
Principal Investigator: Site Reference ID/Investigator# 99799            
Site Reference ID/Investigator# 35308 Recruiting
Neubrandenburg, Germany, 17033
Principal Investigator: Site Reference ID/Investigator# 35308            
Site Reference ID/Investigator# 35307 Recruiting
Neubrandenburg, Germany, 17033
Principal Investigator: Site Reference ID/Investigator# 35307            
Site Reference ID/Investigator# 34069 Recruiting
Neumuenster, Germany, 24534
Principal Investigator: Site Reference ID/Investigator# 34069            
Site Reference ID/Investigator# 53172 Recruiting
Neuruppin, Germany, 16816
Principal Investigator: Site Reference ID/Investigator# 53172            
Site Reference ID/Investigator# 34073 Recruiting
Neustadt, Germany, 1844
Principal Investigator: Site Reference ID/Investigator# 34073            
Site Reference ID/Investigator# 58769 Recruiting
Neuwied, Germany, 56564
Principal Investigator: Site Reference ID/Investigator# 58769            
Site Reference ID/Investigator# 53159 Recruiting
Neuwied, Germany, 56564
Principal Investigator: Site Reference ID/Investigator# 53159            
Site Reference ID/Investigator# 58759 Recruiting
Nienburg, Germany, 31582
Principal Investigator: Site Reference ID/Investigator# 58759            
Site Reference ID/Investigator# 34156 Recruiting
Nienburg, Germany, 31582
Principal Investigator: Site Reference ID/Investigator# 34156            
Site Reference ID/Investigator# 34162 Recruiting
Nordhausen, Germany, 99734
Principal Investigator: Site Reference ID/Investigator# 34162            
Site Reference ID/Investigator# 53166 Recruiting
Nuremberg, Germany, 90449
Principal Investigator: Site Reference ID/Investigator# 53166            
Site Reference ID/Investigator# 51866 Recruiting
Offenburg, Germany, 77652
Principal Investigator: Site Reference ID/Investigator# 51866            
Site Reference ID/Investigator# 33493 Recruiting
Oldenburg, Germany, 26122
Principal Investigator: Site Reference ID/Investigator# 33493            
Site Reference ID/Investigator# 33494 Recruiting
Oldenburg, Germany, 26121
Principal Investigator: Site Reference ID/Investigator# 33494            
Site Reference ID/Investigator# 48891 Recruiting
Oldenburg, Germany, 26123
Principal Investigator: Site Reference ID/Investigator# 48891            
Site Reference ID/Investigator# 33500 Recruiting
Osnabrueck, Germany, 49074
Principal Investigator: Site Reference ID/Investigator# 33500            
Site Reference ID/Investigator# 33498 Recruiting
Osnabrueck, Germany, 49078
Principal Investigator: Site Reference ID/Investigator# 33498            
Site Reference ID/Investigator# 35331 Recruiting
Osnabrueck, Germany, 49076
Principal Investigator: Site Reference ID/Investigator# 35331            
Site Reference ID/Investigator# 33501 Recruiting
Paderborn, Germany, 33098
Principal Investigator: Site Reference ID/Investigator# 33501            
Site Reference ID/Investigator# 33502 Recruiting
Paderborn, Germany, 33098
Principal Investigator: Site Reference ID/Investigator# 33502            
Site Reference ID/Investigator# 35337 Recruiting
Papenburg, Germany, 26871
Principal Investigator: Site Reference ID/Investigator# 35337            
Site Reference ID/Investigator# 33525 Recruiting
Plauen, Germany, 8523
Principal Investigator: Site Reference ID/Investigator# 33525            
Site Reference ID/Investigator# 33460 Recruiting
Potsdam, Germany, 14467
Principal Investigator: Site Reference ID/Investigator# 33460            
Site Reference ID/Investigator# 33463 Recruiting
Potsdam, Germany, 14471
Principal Investigator: Site Reference ID/Investigator# 33463            
Site Reference ID/Investigator# 105639 Recruiting
Radevormwald, Germany, 42477
Principal Investigator: Site Reference ID/Investigator# 105639            
Site Reference ID/Investigator# 33489 Recruiting
Recklinghausen, Germany, 45659
Principal Investigator: Site Reference ID/Investigator# 33489            
Site Reference ID/Investigator# 53344 Recruiting
Regensburg, Germany, 93053
Principal Investigator: Site Reference ID/Investigator# 53344            
Site Reference ID/Investigator# 58761 Recruiting
Remscheid, Germany, 42859
Principal Investigator: Site Reference ID/Investigator# 58761            
Site Reference ID/Investigator# 53142 Recruiting
Rinteln, Germany, 31737
Principal Investigator: Site Reference ID/Investigator# 53142            
Site Reference ID/Investigator# 33924 Recruiting
Rostock, Germany, 18107
Principal Investigator: Site Reference ID/Investigator# 33924            
Site Reference ID/Investigator# 48886 Recruiting
Rostock, Germany, 18057
Principal Investigator: Site Reference ID/Investigator# 48886            
Site Reference ID/Investigator# 33932 Recruiting
Rottenburg, Germany, 72108
Principal Investigator: Site Reference ID/Investigator# 33932            
Site Reference ID/Investigator# 34012 Recruiting
Ruedersdorf, Germany, 15562
Principal Investigator: Site Reference ID/Investigator# 34012            
Site Reference ID/Investigator# 91113 Recruiting
Saarbruecken, Germany, 66111
Principal Investigator: Site Reference ID/Investigator# 91113            
Site Reference ID/Investigator# 91115 Recruiting
Sauerlach, Germany, 82054
Principal Investigator: Site Reference ID/Investigator# 91115            
Site Reference ID/Investigator# 73838 Recruiting
Schleswig, Germany, 24837
Principal Investigator: Site Reference ID/Investigator# 73838            
Site Reference ID/Investigator# 34029 Recruiting
Schmalkalden, Germany, 98574
Principal Investigator: Site Reference ID/Investigator# 34029            
Site Reference ID/Investigator# 48892 Recruiting
Schwalmstadt, Germany, 34613
Principal Investigator: Site Reference ID/Investigator# 48892            
Site Reference ID/Investigator# 35137 Recruiting
Schwarz, Germany, 17252
Principal Investigator: Site Reference ID/Investigator# 35137            
Site Reference ID/Investigator# 33545 Recruiting
Schweinfurt, Germany, 97421
Principal Investigator: Site Reference ID/Investigator# 33545            
Site Reference ID/Investigator# 33551 Recruiting
Schwerin, Germany, 19053
Principal Investigator: Site Reference ID/Investigator# 33551            
Site Reference ID/Investigator# 58760 Recruiting
Solingen, Germany, 42651
Principal Investigator: Site Reference ID/Investigator# 58760            
Site Reference ID/Investigator# 53286 Recruiting
Stade, Germany, 21682
Principal Investigator: Site Reference ID/Investigator# 53286            
Site Reference ID/Investigator# 33582 Recruiting
Stade, Germany, 21682
Principal Investigator: Site Reference ID/Investigator# 33582            
Site Reference ID/Investigator# 33581 Recruiting
Stade, Germany, 21682
Principal Investigator: Site Reference ID/Investigator# 33581            
Site Reference ID/Investigator# 33593 Recruiting
Stralsund, Germany, 18439
Principal Investigator: Site Reference ID/Investigator# 33593            
Site Reference ID/Investigator# 48896 Recruiting
Strausberg, Germany, 15344
Principal Investigator: Site Reference ID/Investigator# 48896            
Site Reference ID/Investigator# 48894 Recruiting
Stuhr, Germany, 28816
Principal Investigator: Site Reference ID/Investigator# 48894            
Site Reference ID/Investigator# 53263 Recruiting
Stuttgart, Germany, 70565
Principal Investigator: Site Reference ID/Investigator# 53263            
Site Reference ID/Investigator# 33599 Recruiting
Stuttgart, Germany, 70565
Principal Investigator: Site Reference ID/Investigator# 33599            
Site Reference ID/Investigator# 33612 Recruiting
Stuttgart, Germany, D-70376
Principal Investigator: Site Reference ID/Investigator# 33612            
Site Reference ID/Investigator# 35385 Recruiting
Stuttgart, Germany, 70176
Principal Investigator: Site Reference ID/Investigator# 35385            
Site Reference ID/Investigator# 91114 Recruiting
Teuchern, Germany, 06682
Principal Investigator: Site Reference ID/Investigator# 91114            
Site Reference ID/Investigator# 58753 Recruiting
Traunstein, Germany, 83278
Principal Investigator: Site Reference ID/Investigator# 58753            
Site Reference ID/Investigator# 33630 Recruiting
Tuebingen, Germany, 72076
Principal Investigator: Site Reference ID/Investigator# 33630            
Site Reference ID/Investigator# 73848 Recruiting
Tutzing, Germany, 82327
Principal Investigator: Site Reference ID/Investigator# 73848            
Site Reference ID/Investigator# 48893 Recruiting
Uelzen, Germany, 29525
Principal Investigator: Site Reference ID/Investigator# 48893            
Site Reference ID/Investigator# 33726 Recruiting
Ulm, Germany, 89081
Principal Investigator: Site Reference ID/Investigator# 33726            
Site Reference ID/Investigator# 58771 Recruiting
Ulm, Germany, 89073
Principal Investigator: Site Reference ID/Investigator# 58771            
Site Reference ID/Investigator# 53164 Recruiting
Urbach, Germany, 73660
Principal Investigator: Site Reference ID/Investigator# 53164            
Site Reference ID/Investigator# 33731 Recruiting
Vechta, Germany, 49377
Principal Investigator: Site Reference ID/Investigator# 33731            
Site Reference ID/Investigator# 53251 Recruiting
Vilshofen, Germany, 94474
Principal Investigator: Site Reference ID/Investigator# 53251            
Site Reference ID/Investigator# 33744 Recruiting
Waren, Germany, 17192
Principal Investigator: Site Reference ID/Investigator# 33744            
Site Reference ID/Investigator# 53287 Recruiting
Weilheim, Germany, 82362
Principal Investigator: Site Reference ID/Investigator# 53287            
Site Reference ID/Investigator# 33763 Recruiting
Wiesbaden, Germany, 65185
Principal Investigator: Site Reference ID/Investigator# 33763            
Site Reference ID/Investigator# 35409 Recruiting
Wiesbaden, Germany, 65189
Principal Investigator: Site Reference ID/Investigator# 35409            
Site Reference ID/Investigator# 33769 Recruiting
Wilhelmshaven, Germany, 26382
Principal Investigator: Site Reference ID/Investigator# 33769            
Site Reference ID/Investigator# 67704 Recruiting
Witten, Germany, 58452
Principal Investigator: Site Reference ID/Investigator# 67704            
Site Reference ID/Investigator# 53146 Recruiting
Wittenberge, Germany, 19322
Principal Investigator: Site Reference ID/Investigator# 53146            
Site Reference ID/Investigator# 35083 Recruiting
Wriezen, Germany, 16269
Principal Investigator: Site Reference ID/Investigator# 35083            
Site Reference ID/Investigator# 73849 Recruiting
Wuerselen, Germany, 52146
Principal Investigator: Site Reference ID/Investigator# 73849            
Site Reference ID/Investigator# 81619 Recruiting
Wuerselen, Germany, 52146
Principal Investigator: Site Reference ID/Investigator# 81619            
Site Reference ID/Investigator# 99805 Recruiting
Wuerzburg, Germany, 97070
Principal Investigator: Site Reference ID/Investigator# 99805            
Site Reference ID/Investigator# 33868 Recruiting
Zittau, Germany, 2763
Principal Investigator: Site Reference ID/Investigator# 33868            
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Stefan Simianer, MD AbbVie Deutschland GmbH & Co. KG, Medical Department
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( 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: May 21, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

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

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

ClinicalTrials.gov processed this record on May 21, 2013