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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01083680
First received: February 26, 2010
Last updated: August 20, 2014
Last verified: August 2014

February 26, 2010
August 20, 2014
June 2007
December 2019   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT01083680 on ClinicalTrials.gov Archive Site
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Effectiveness and Safety in Patients With Crohn´s Disease in Clinical Routine
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

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Community sample: patients with Crohn's Disease

Crohn´s Disease
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Crohn's Disease patients
Patients with Crohn's Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2500
December 2019
December 2019   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Gerd Greger, PhD +49 611 1720-1610 gerd.greger@abbvie.com
Contact: Elisabeth Glaser-Caldow #49 611 1720-1235 elisabeth.glaser@abbvie.com
Germany
 
NCT01083680
P10-278
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Bianca Wittig, MD AbbVie Deutschland GmbH & Co. KG, Medical Department
AbbVie
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP