Full Text View
Tabular View
No Study Results Posted
Related Studies
Effectiveness and Safety in Patients With Crohn´s Disease in Clinical Routine
This study is currently recruiting participants.
Verified by Abbott, June 2010
First Received: February 26, 2010   Last Updated: June 21, 2010   History of Changes
Sponsor: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT01083680
  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 Severe Active Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Abbott:

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: 724
Study Start Date: June 2007
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (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.

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's assessment of disease activity will be collected using the Physician's 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@abbott.com
Contact: Elisabeth Glaser-Caldow #49 6122 581235 elisabeth.glaser@abbott.com

  Show 227 Study Locations
Sponsors and Collaborators
Abbott
Investigators
Study Director: Bianca Wittig, MD Abbott Germany, Medical Department
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Department, Wiesbaden Germany ( Dr. Bianca Wittig / Head of Medical Development Immunology (Acting Medical Director) )
ClinicalTrials.gov Identifier: NCT01083680     History of Changes
Other Study ID Numbers: P10-278
Study First Received: February 26, 2010
Last Updated: June 21, 2010
Health Authority: Germany: Paul-Ehrlich-Institut

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

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 September 01, 2010