DICE INCIDENCE CAPTURE: Determinants, Incidence, and consequences of Corticosteroid Excess in IBD

DICE INCIDENCE CAPTURE: Determinants, Incidence, and consequences of Corticosteroid Excess in IBD - DICE

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00025270

Enrollment

3500

Registered

2021-07-12

Start date

2021-07-26

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. Web-based Steroid Assessment Tool (SAT) for collecting patient-level data on the use of corticosteroids in IBD patients from files 2. Questionnaire on

this questionnaire asks the Centre about the facilities and services to which it has access. 3. Patient questionnaire for collecting data on past use of steroids and patient attitudes to steroids.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients diagnosed with IBD >1year Patient attending IBD clinic visit (or clinical assessments performed by phone/web, where applicable)

Exclusion criteria

Exclusion criteria: Suspected but not yet confirmed IBD Post-colectomy UC patients with no evidence for Crohn's disease Patients <18 years old Patients receiving investigational products and enrolled in clinical studies Any of the following conditions: Solid organ transplantation (any), adrenal insufficiency/Addison’s disease/hypopituitarism, Autoimmune hepatitis, Polymyalgia rheumatica, Uveitis, Systemic lupus erythematousus, Rheumatoid arthritis, Giant cell arteritis, Vasculitis (various subtypes/pseudonyms), haemolytic anaemia

Design outcomes

Primary

Measure	Time frame
To determine incidence of steroid exposure and excess for patients with IBD and to identify associated variables that may influence these at both patient level (e.g. disease subtype, prescribed medications) and system level (e.g. access to IBD specialists. There will be three sources of data: 1. Web-based Steroid Assessment Tool (SAT) for collecting patient-level data on the use of corticosteroids in IBD patients from files 2. Questionnaire on the criteria for the provision of services, which collects information on the Centre; this questionnaire asks the Centre about the facilities and services to which it has access. • Academic or public centre • Population size in the centre’s catchment area • IBD Telephone Service • Structure of the IBD department, e.g. number of gastroenterologists, caregivers and trainees • Access to multidisciplinary teams and frequency of meetings • Research institutions This will take into account differences in facilities/health systems to assess steroid use globally and in individual countries. 3. Patient questionnaire with overlapping questions asked by the physician in SAT and additional questions on the patient’s attitude towards steroids Explanatory variables: • Disease subtype (e.g. Crohn’s disease, ulcerative colitis) • Severe illness • Use of thiopurines • Use of 5-ASA (5-aminosalicylic acid) • Use of targeted therapies • Recent start of targeted therapy • Type of study center (e.g. tertiary care, teaching hospital, university hospital) • Trainee-led clinics • Presence of IBD study nurse • Multidisciplinary meeting team • Presence of IBD telephone service • Specialised IBD center The data are collected in total and by subgroup, e.g. The incidence of these adverse reactions is estimated by the following factors: age, sex, and severity, using absolute frequencies and percentages. 95% confidence intervals for prevalence are calculated. A simple logistic regression is performed for primary endpoints to separate	—

Measure

Time frame

To determine incidence of steroid exposure and excess for patients with IBD and to identify associated variables that may influence these at both patient level (e.g. disease subtype, prescribed medications) and system level (e.g. access to IBD specialists. There will be three sources of data: 1. Web-based Steroid Assessment Tool (SAT) for collecting patient-level data on the use of corticosteroids in IBD patients from files 2. Questionnaire on the criteria for the provision of services, which collects information on the Centre; this questionnaire asks the Centre about the facilities and services to which it has access. • Academic or public centre • Population size in the centre’s catchment area • IBD Telephone Service • Structure of the IBD department, e.g. number of gastroenterologists, caregivers and trainees • Access to multidisciplinary teams and frequency of meetings • Research institutions This will take into account differences in facilities/health systems to assess steroid use globally and in individual countries. 3. Patient questionnaire with overlapping questions asked by the physician in SAT and additional questions on the patient’s attitude towards steroids Explanatory variables: • Disease subtype (e.g. Crohn’s disease, ulcerative colitis) • Severe illness • Use of thiopurines • Use of 5-ASA (5-aminosalicylic acid) • Use of targeted therapies • Recent start of targeted therapy • Type of study center (e.g. tertiary care, teaching hospital, university hospital) • Trainee-led clinics • Presence of IBD study nurse • Multidisciplinary meeting team • Presence of IBD telephone service • Specialised IBD center The data are collected in total and by subgroup, e.g. The incidence of these adverse reactions is estimated by the following factors: age, sex, and severity, using absolute frequencies and percentages. 95% confidence intervals for prevalence are calculated. A simple logistic regression is performed for primary endpoints to separate

—

Countries

Australia, Belgium, France, Germany, Israel, Italy, Spain, Turkey

Contacts

Public ContactStefan Rath

AbbVie Deutschland GmbH & Co. KG

stefan.rath@abbvie.com+49 151 14038337

Outcome results

None listed

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