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
  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 ]

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
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 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
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

Contacts
Contact: Gerd Greger, PhD +49 611 1720-1610 gerd.greger@abbvie.com
Contact: Elisabeth Glaser-Caldow #49 611 1720-1235 elisabeth.glaser@abbvie.com

  Show 423 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Bianca Wittig, 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: August 20, 2014
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

ClinicalTrials.gov processed this record on August 21, 2014