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| 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 |
| 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.
|
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 |
Community sample: patients with Crohn's Disease
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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| Study Director: | Bianca Wittig, MD | Abbott Germany, Medical Department |
More Information
| 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 |
|
Crohn's Disease Humira Long-term efficacy and safety Routine clinical setting |
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
Adalimumab Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |