Drug Safety on Biological-therapy through clinical Pharmaceutical care on Inflammatory Bowel Disease.A Prospective Study to determine the influence of Pharmaceutical care on patients Knowledge, drug safety and Quality of Life.
Not Applicable
- Conditions
- K50.9K51.9Crohn disease, unspecifiedUlcerative colitis, unspecified
- Registration Number
- DRKS00020374
- Lead Sponsor
- Apotheke des Universitätsklinikum Erlangen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 127
Inclusion Criteria
IBD Patients, receiving a biological therapy at the Medizinische Klinik 1 - Hochschulambulanz Erlangen
At least 3 months of biological therapy
clinical Remission or mild disease (Partial Mayo Score = 6 or HBI = 8)
female or male
Age: at least 18 years old
Fill in questionnaire
Exclusion Criteria
Missing German language skills
cognitive limitations
Patients which won't accept the Trial
oral Glucocorticoid therapy for active disease
Pregnant or breastfeeding women
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction of adverse events after 12 months of biological therapy<br>Improvement of health related quality of life after 12 months
- Secondary Outcome Measures
Name Time Method Improvement of fatigue after 12 months<br>Improvement of medical knowledge (biological) after 12 months<br>Unsolved medication errors after 12 months
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie drug safety improvements in IBD patients receiving clinical pharmaceutical care?
How does pharmaceutical care compare to standard-of-care in managing adverse events for Crohn's disease and ulcerative colitis?
Are there specific biomarkers associated with enhanced quality of life outcomes in biological therapy for IBD?
What adverse events are commonly reported in DRKS00020374 and how are they managed in clinical practice?
What combination therapies show promise in improving drug safety for K50.9 and K51.9 disease subtypes?