DICE Incidence Capture 2.0: Determinants, Incidence, and consequences of Corticosteroid Excess in IBD in Germany
- Conditions
- K50K51Crohn disease [regional enteritis]Ulcerative colitis
- Registration Number
- DRKS00033064
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 375
•Patients diagnosed with IBD >1 year
•Patient attending IBD clinic visit (or clinical assessments performed by phone/web, where applicable)
•Signed patient consent
•Available medical chart documentation over the last 12 months
•Post-colectomy UC patients with disease limited to the colon
•Patients <19 years old
•Patients that are currently receiving or have received investigational products and enrolled in clinical studies during the last 12 months
•Any of the following conditions:
-Solid organ transplantation (any)
-Adrenal insufficiency/Addison’s disease/hypopituitarism,
-Autoimmune hepatitis
-Polymyalgia rheumatica
-Uveitis
-Systemic lupus erythematosus
-Rheumatoid arthritis
-Giant cell arteritis
-Vasculitis (various subtypes/pseudonyms)
- haemolytic anaemia
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Administration of steroids within the last 12 months as reported by the physician via the SAT.<br>Fulfilment of 1 or more criteria defining steroid dependency and/or steroid use contravening official guidelines as reported by the physician ((i) the prescription of >1 steroid course or (ii) inability to wean steroids below 10 mg/day prednisolone or 3 mg/day budesonide within 3 months of starting steroids or (iii) disease flare within 3 months of stopping steroids).
- Secondary Outcome Measures
Name Time Method •Administration of steroids within the last 12 months as reported by the patient.<br>•Differences in administration of steroids within the last 12 months as reported by the patient and by the physician.<br>•Administration of steroids for more than 50% of the last 12 months as reported by the patient.<br>•Prescription of a bone protection medication as reported by the physician via the SAT.<br>•Treatment with a biologic or a small molecule alongside administration of steroids within the last 12 months as reported by the physician via the SAT.<br>•Number of oral steroid courses received by patients within the last 12 months as reported by the physician via the SAT.<br>•Duration of steroid treatment received by the patients within the last 12 months as reported by the physician via the SAT.