Biologica in patients with ulcerative colitis in Germany (BioColitis study)

Biologica in patients with ulcerative colitis in Germany (BioColitis study) - BioColitis Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00009219

Enrollment

1000

Registered

2015-08-11

Start date

2013-04-27

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

Interventions

Group 1: UC patlents (age at enrollment: 18-80 years) receivig a new biologics tiherapy with Adalimumab, lnfliximab, Golimumab or Vedolizumab. A former TNF-alpha therapy with other biologics is all

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Age 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 UC-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 in biologic patients with ulcerative colitis (hospitalizations, disability, cost of treatment, quality of life). 5. Generation of follow-up data on UC-patients with early disease (Initiation of documentation < 2 years alter flrst diagnosis) and UC-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 of partial mayo 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 UC-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 in biologic patients with ulcerative colitis (hospitalizations, disability, cost of treatment, quality of life). 5. Generation of follow-up data on UC-patients with early disease (Initiation of documentation < 2 years alter flrst diagnosis) and UC-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 of partial mayo score and the quality of life is determined by patient questionnaires such as WPAI and EQ-5D .

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Countries

Germany

Outcome results

None listed

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