Early Predictive parameters for a progressive disease course In ulcerative Colitis patients [EPICOL]

Early Predictive parameters for a progressive disease course In ulcerative Colitis patients [EPICOL] - EPICOL

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00010933

Enrollment

300

Registered

2016-08-05

Start date

2015-01-15

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

K51.9

Interventions

Group 1: baseline visit: - Patient Demographics (i.e. age, gender, body height and weight, tobacco use) - UC-related medical history (incl. date of first UC flare and date of UC diagnosis, family hist

12]) (if respective data are available) - Mucosal healing status (if respective data are available) - Change in UC-related medication - Change in surgical status - Number/frequency of unscheduled/emer

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
- Prospectively evaluate the major predictive clinical parameters available during the early phase of ulcerative colitis disease in a large patient population. - 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).	—

Measure

Time frame

- Prospectively evaluate the major predictive clinical parameters available during the early phase of ulcerative colitis disease in a large patient population. - 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

Measure	Time frame
- 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	—

Countries

Germany

Contacts

Public ContactSusanne Freibert

AbbVie Deutschland GmbH & Co. KG, Medical Immunology

susanne.freibert@abbvie.com+49 160 90774108

Outcome results

None listed

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