N/A
N=106
Anti-Tumor Necrosis Factor (TNF) Treatments, Work Productivity and Quality of Life in Crohn's Disease
Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01860846 ↗Enrolled (actual)
106
Serious AEs
1.9%
Results posted
Jun 2017
Primary outcome: Primary: Work Productivity and Activity Index (WPAI): Absenteeism — 38.3; 14.2 units on a scale — p==0.004
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Feb 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Work Productivity and Activity Index (WPAI): Absenteeism |
38.3; 14.2 | =0.004 sig |
| PRIMARY Work Productivity and Activity Index (WPAI): Presenteeism |
39.8; 21.8 | = 0.022 sig |
| PRIMARY Total Work Productivity Impairment (TWPI) |
24.2; 15.7 | = 0.006 sig |
| PRIMARY Total Activity Impairment (TAI) |
47.0; 30.0 | < 0.001 sig |
| SECONDARY Change in Short Form 36 (SF-36) Health Survey Scores |
62.8; 81.2; 29.3; 67.2; 35.2; 62.8 | < 0.001 sig |
| SECONDARY Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores |
4.5; 5.2; 3.8; 4.9; 4.0; 4.7 | < 0.001 sig |
| SECONDARY Change in Extra-intestinal Symptoms |
20; 8; 7; 3; 0; 0 | — |
| SECONDARY Number of Participants With Serious Adverse Events |
2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01860846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.