DICE Incidence Capture 2.0: Determinants, Incidence, and consequences of Corticosteroid Excess in IBD in Germany

DICE Incidence Capture 2.0: Determinants, Incidence, and consequences of Corticosteroid Excess in IBD in Germany - DICE 2.0

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00033064

Enrollment

375

Registered

2024-04-16

Start date

2024-06-24

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K50 K51

Interventions

Group 1: There will be three sources of data: 1. Steroid assessment questionnaire within the eCRF collecting patient level data from charts related to corticosteroid use in IBD patients wihtin the pas

Eligibility

Sex/Gender

All

Age

19 Years to No maximum

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Primary

Measure	Time frame
Administration of steroids within the last 12 months as reported by the physician via the SAT. 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).	—

Measure

Time frame

Administration of steroids within the last 12 months as reported by the physician via the SAT. 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

Measure	Time frame
• Administration of steroids within the last 12 months as reported by the patient. • Differences in administration of steroids within the last 12 months as reported by the patient and by the physician. • Administration of steroids for more than 50% of the last 12 months as reported by the patient. • Prescription of a bone protection medication as reported by the physician via the SAT. • 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. • Number of oral steroid courses received by patients within the last 12 months as reported by the physician via the SAT. • Duration of steroid treatment received by the patients within the last 12 months as reported by the physician via the SAT.	—

Measure

Time frame

• Administration of steroids within the last 12 months as reported by the patient. • Differences in administration of steroids within the last 12 months as reported by the patient and by the physician. • Administration of steroids for more than 50% of the last 12 months as reported by the patient. • Prescription of a bone protection medication as reported by the physician via the SAT. • 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. • Number of oral steroid courses received by patients within the last 12 months as reported by the physician via the SAT. • Duration of steroid treatment received by the patients within the last 12 months as reported by the physician via the SAT.

—

Countries

Germany

Contacts

Public ContactStefan Rath

AbbVie Deutschland GmbH & CO. KG

info@abbvie.com+490611 17200

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026