Status:
COMPLETED
Anti-Tumor Necrosis Factor (TNF) Treatments, Work Productivity and Quality of Life in Crohn's Disease
Lead Sponsor:
AbbVie
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-65 years
Brief Summary
This multicenter, prospective, post marketing observational study (PMOS) was designed to demonstrate long-term effects of anti-Tumor Necrosis Factor therapies on Work Productivity and Impairment scale...
Detailed Description
Male or female participants between 18 - 65 years of age with moderate to severe CD for whom the treating physician had recently initiated an anti-TNF treatment were included in this study. Anti-TNF t...
Eligibility Criteria
Inclusion
- Male or female participants between 18-65 years of age with moderately to severely (Crohn's Disease Activity Index 220-450) active Crohn's Disease with or without fistula formation
- Participants who were able to provide authorization to use and disclose information related to the study
- Proven diagnosis of Crohn's Disease in accordance with international diagnostic criteria such as European Crohn's and Colitis Organization (ECCO) guidelines
- Participants for whom the physician had initiated anti-Tumor Necrosis Factor treatment in accordance with Turkish Ministry of Health regulations and reimbursements
Exclusion
- Participants who had a history of any kind of biological therapy and/or anti-Tumor Necrosis Factor treatments for Crohn's Disease or other indications
- Participants who had septic complications (active infection and/or active tuberculosis (TB), undrained abscess)
- Participants who had bowel obstructions and fibrotic strictures
- Participants who had received any investigational drug within 30 days prior to the Visit 1 at baseline
- For any reason, participants who were considered by the investigator to be unsuitable
Key Trial Info
Start Date :
May 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT01860846
Start Date
May 1 2013
End Date
February 1 2016
Last Update
June 16 2017
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.