Biologica in patients with Crohn's disease in Germany

Biologica in patients with Crohn's disease in Germany - BioCrohn

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00009234

Enrollment

1500

Registered

2015-08-17

Start date

2008-09-29

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

Interventions

Group 1: CD patlents (age at enrollment: 18-80 years) receivig a new biologics tiherapy. A former TNF-alpha therapy with other biologics is allowed. The side effects of treatment will be documented in

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Crohn's disease patients (age at inclusion: 18-80 years ) with a new biologics therapy with Adalimumab, Infliximab, Certolizumab, Golimumab or Vedolizumab. 2. Crohn's disease patients (age at inclusion: 18-80 years ) with an early disease history (initial diagnosis < 3 years).

Exclusion criteria

Exclusion criteria: Age under 18 years and over 80 years

Design outcomes

Primary

Measure	Time frame
1. Online documentation of serious siede effects (death, tumor, tuberculosis, serious infection or other siede effects requiring hospitalization) on bioloogics therapy. 2. Online documentation of CD-patients on biologics therapy with special reference to complications and any side elfects. 3. Documentation of disease course (disease activity, phenotype) on biologics therapy. 4. Generation of health econornic data and disease burden data in biologic patients with Crohn's disease (hospitalizations, disability, cost of treatment, quality of life). 5. Generation of follow-up data on CD-patients with early disease (Initiation of documentation < 3 years alter flrst diagnosis) and CD-patients on biologica therapy, with reference to treatment modalities and psychosocial impaiment among patients. 6. Review of genetic disposition of various patient populations to identify possible predictors of likely course/outcome. Data are collected online every 6 months over a period of 60 months . Disease activity is determined by means ofHBI score and the quality of life is determined by patient questionnaires such as WPAI and EQ-5D.	—

Measure

Time frame

1. Online documentation of serious siede effects (death, tumor, tuberculosis, serious infection or other siede effects requiring hospitalization) on bioloogics therapy. 2. Online documentation of CD-patients on biologics therapy with special reference to complications and any side elfects. 3. Documentation of disease course (disease activity, phenotype) on biologics therapy. 4. Generation of health econornic data and disease burden data in biologic patients with Crohn's disease (hospitalizations, disability, cost of treatment, quality of life). 5. Generation of follow-up data on CD-patients with early disease (Initiation of documentation < 3 years alter flrst diagnosis) and CD-patients on biologica therapy, with reference to treatment modalities and psychosocial impaiment among patients. 6. Review of genetic disposition of various patient populations to identify possible predictors of likely course/outcome. Data are collected online every 6 months over a period of 60 months . Disease activity is determined by means ofHBI score and the quality of life is determined by patient questionnaires such as WPAI and EQ-5D.

—

Countries

Germany

Contacts

Public ContactKaren Schmidt

CED Service GmbH

k.schmidt@kompetenznetz-darmerkrankungen.de0431 580-90640

Outcome results

None listed

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