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


N/A
18 Years
65 Years
Open (Enrolling)
Both
Crohn's Disease

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Trial Information

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


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.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Evaluation of Work Absenteeism

Outcome Description:

To collect the number of missed working days and the number of working days

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Mahmut Gücük, MD

Investigator Role:

Study Director

Investigator Affiliation:

AbbVie

Authority:

Turkey: Ministry of Health

Study ID:

P13-338

NCT ID:

NCT01860846

Start Date:

May 2013

Completion Date:

November 2015

Related Keywords:

  • Crohn's Disease
  • Crohn's disease
  • Crohn Disease

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