Early Predictive parameters for a progressive disease course In ulcerative Colitis patients [EPICOL]
- Conditions
- K51.9Ulcerative colitis, unspecified
- Registration Number
- DRKS00010933
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 310
Inclusion Criteria
• Patients with a recent, proven diagnosis of active UC (not more than 6 months from baseline)
• Age = 18 years
• Naïve to treatment with conventional immunosuppressants (thiopurines, calcineurin inhibitors, or equivalent therapy) and /or TNF antagonists (or equivalent biologic) at baseline
• No prior UC-related surgery
Exclusion Criteria
• Patients whose diagnosis of active UC was made more than 6 months ago;
• Patients who are not naïve to treatment with conventional immunosuppressants (thiopurines, calcineurin inhibitors, or equivalent therapy) and/or TNF antagonists (or equivalent biologic) at baseline;
• Proctitis (up to 15 cm);
• Prior UC-related surgery;
• Pregnancy
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Prospectively evaluate the major predictive clinical parameters available during the early phase of ulcerative colitis disease in a large patient population. <br>- Identify patients at an early disease stage who subsequently will exhibit a severe UC course, defined as the need for hospitalization (primary endpoint) and/or need for immunosuppressive treatment (e.g. thiopurines, calcineurin inhibitors, Tumor Necrosis Factor [TNF] antagonists; secondary endpoint).
- Secondary Outcome Measures
Name Time Method - Identify a rationale that allows early intensive treatment with immunomodulating agents (e.g. thiopurines, calcineurin inhibitors, TNF antagonists) of patients at high risk for a severe UC course