Early Predictive parameters of Immunosuppressivetherapy in Crohn's disease (EPIC)
- Conditions
- K50Crohn disease [regional enteritis]
- Registration Number
- DRKS00010935
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 341
Inclusion Criteria
Patients with a recent diagnosis (not more than 6 months) of active Crohn's
disease
= 18 years
naïve to conventional immunosuppressives (thiopurines, methotrexate,
calcineurin inhibitors, etc) and biologics at baseline
Exclusion Criteria
Patients whose diagnosis of active Crohn's disease was made more than 6 months ago
Patients who are not naïve to conventional immunosuppressives (thiopurines,
methotrexate, calcineurin inhibitors, etc) and biologics at baseline
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients (in %) who need immunosuppressive therapy within 24 months from enrollment with at least one of the defined major predictive parameters:<br>- age at onset<br>- ileocolonic disease<br>- joint manifestations<br>- cutaneous manifestations<br>- steroids at first flare<br>- no response to steroids at any flare
- Secondary Outcome Measures
Name Time Method Proportion of patients (in %) who are hospitalized because of their Crohn’s disease within 24 months from enrollment with at least one of the above stated major predictive parameters<br>