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NCT01860846 Clinical Trial

Improvement of Work Productivity and Quality of Life With Anti-Tumor Necrosis Factor (TNF) Therapies Used in Crohn's Disease in Routine Clinical Practice in Turkey

Crohn's Disease Clinical Trial

— IDEA  

Official title:
Improvement of Work Productivity and Quality of Life With Anti-TNF Therapies Used in Crohn's Disease in Routine Clinical Practice in Turkey

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01860846
Other study ID # P13-338
Secondary ID
Status Completed
Phase N/A
First received May 21, 2013
Last updated February 17, 2016
Start date May 2013
Est. completion date February 2016

Study information
Verified date February 2016
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics CommitteeTurkey: Ministry of Health
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

Turkey, 

Outcome
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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Active, not recruiting NCT02316678 - Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics N/A
Completed NCT02193048 - Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
Completed NCT02197780 - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD N/A
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Completed NCT02265588 - Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD). N/A
Recruiting NCT02395354 - Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease N/A
Completed NCT01958827 - A Study of Adalimumab After Dose Escalation in Japanese Subjects With Crohn's Disease Phase 3

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