Clinical trial NCT01860846: Anti-Tumor Necrosis Factor (TNF) Treatments, Work Productivity and Quality of Life in Crohn's Disease
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Keywords: Crohn's Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2013-05-23
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with Crohn's Disease who at the time of study entry were receiving anti-Tumor Necrosis Factor treatment as prescribed in accordance with Turkish Ministry of Health regulations and reimbursement conditions

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 scales in participants with moderate to severe Crohn's Disease (CD) under routine conditions. Secondary objectives of this study were long-term improvement of Quality of Life (QoL), evaluation of improvement of extraintestinal symptoms and comorbidities, and evaluation of safety.

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 treatments were administered according to the treating physician's decision and applicable product label in Turkey. No interventions were made to the treatment and the participant discontinuance or to the follow-up decisions of the treating physician. Enrolled participants were observed for one year.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Work Productivity and Activity Index (WPAI): Absenteeism
timeFrame: At baseline and 12 months
measure: Work Productivity and Activity Index (WPAI): Presenteeism
timeFrame: At baseline and 12 months
measure: Total Work Productivity Impairment (TWPI)
timeFrame: At baseline and 12 months
measure: Total Activity Impairment (TAI)
timeFrame: At baseline and 12 months
Secondary outcomes:
measure: Change in Short Form 36 (SF-36) Health Survey Scores
timeFrame: At baseline and 12 months
measure: Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores
timeFrame: At baseline and 12 months
measure: Change in Extra-intestinal Symptoms
timeFrame: At baseline and 12 months
measure: Number of Participants With Serious Adverse Events
timeFrame: From the time of informed consent until 30 days or 5 half-lives following the last dose, up to 62 weeks
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Mahmut Gücük, MD
role: STUDY_DIRECTOR
References: