Crohn's Disease Clinical Trial
— IDEAOfficial title:
Improvement of Work Productivity and Quality of Life With Anti-TNF Therapies Used in Crohn's Disease in Routine Clinical Practice in Turkey
Verified date | February 2016 |
Source | AbbVie |
Contact | n/a |
Is FDA regulated | No |
Health authority | Turkey: Ethics CommitteeTurkey: Ministry of Health |
Study type | Observational |
This post marketing observational study (PMOS) is designed to collect long-term data on the work productivity and changes in quality of life measurements with anti-Tumor Necrosis Factor therapies in patients with moderate to severe Crohn's disease whom are intolerant or/and unresponsive to conventional therapy.
Status | Completed |
Enrollment | 104 |
Est. completion date | February 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Male or female patients between 18-65 years of age with moderately/severely (Crohn's Disease Activity Index 220-450) active Crohn's disease with/without fistula formation - Patients who are able to provide authorization to use and disclose information related with the study - Proven diagnosis of Crohn's Disease in accordance with international diagnostic criteria such as European Crohn's and Colitis Organisation (ECCO) guidelines - Patients for whom the physician has initiated Crohn's disease treatment with anti-Tumor Necrosis Factors in accordance with Turkish Ministry of Health regulations and reimbursements. Exclusion Criteria: - Subject has a history of any kind of biological therapy and/or anti-Tumor Necrosis Factor treatments for Crohn's disease or other indications - Subject has septic complications (active infection and/or active Tuberculosis, undrained abscess) - Patients who have bowel obstructions and fibrotic strictures - Subject has received any investigational drug within 30 days prior to the Visit 1 at baseline - For any reason, subject is considered by the investigator to be an unsuitable. |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Turkey | Site Reference ID/Investigator# 62756 | Ankara | |
Turkey | Site Reference ID/Investigator# 67902 | Ankara | |
Turkey | Site Reference ID/Investigator# 67904 | Ankara | |
Turkey | Site Reference ID/Investigator# 67909 | Bornova, Izmir | |
Turkey | Site Reference ID/Investigator# 67905 | Edirne | |
Turkey | Site Reference ID/Investigator# 67907 | Istanbul | |
Turkey | Site Reference ID/Investigator# 67912 | Istanbul | |
Turkey | Site Reference ID/Investigator# 67915 | Istanbul | |
Turkey | Site Reference ID/Investigator# 93553 | Istanbul | |
Turkey | Site Reference ID/Investigator# 67913 | Izmir | |
Turkey | Site Reference ID/Investigator# 67914 | Izmir | |
Turkey | Site Reference ID/Investigator# 93554 | Kocaeli | |
Turkey | Site Reference ID/Investigator# 94495 | Konya | |
Turkey | Site Reference ID/Investigator# 67910 | Mersin | |
Turkey | Site Reference ID/Investigator# 67906 | Sihhiye Ankara |
Lead Sponsor | Collaborator |
---|---|
AbbVie |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of Work Absenteeism | To collect the number of missed working days and the number of working days | 12 months | No |
Primary | Total Work Productivity Impairment (TWPI) | To collect Total Work Productivity Impairment by Total Work Productivity Impairment Scale | 12 months | No |
Primary | Total Activity Impairment (TAI) scales | To collect Total Activity Impairment by Total Activity Impairment Scale | 12 months | No |
Secondary | Average Short Form Health Survey-36 (SF-36) score change | Day 0 to 12 months | No | |
Secondary | Average Inflammatory Bowel Disease Questionnaire (IBDQ) score change | Day 0 to 12 months | No | |
Secondary | Number of Subjects with Serious Adverse Events | 12 months | Yes |
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