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Recruiting NCT07319442

CEDUR - German IBD Registry

— Observational Ulcerative Colitis (UC) Indeterminate Colitis Crohn Disease (CD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Ulcerative Colitis (UC), Indeterminate Colitis, Crohn Disease (CD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Long-term Observation of IBD Patients, a Nationwide German IBD Registry "CEDUR"

Overview

The CEDUR registry systematically collects real-world data on inflammatory bowel disease (IBD) patients in Germany. The registry aims to assess quality of care, disease activity, treatment effectiveness, safety, and pharmacoeconomic aspects under routine clinical conditions.

Detailed description

CEDUR is a multicenter, web-based, observational registry for adult IBD patients in Germany. The registry includes Crohn's disease, ulcerative colitis, and indeterminate colitis. Data are collected prospectively from physicians and patients, covering clinical parameters, quality of life, treatment patterns, and safety outcomes. The registry supports the evaluation of care quality, cost-effectiveness, and long-term therapy outcomes under real-life conditions.

Primary outcome measures

  • Crohn's Disease Activity Index (CDAI) [Time frame: Up to 10 years of follow-up]
  • Partial Mayo Score [Time frame: Up to 10 years of follow-up]
  • Mayo Score (Full Mayo Score) [Time frame: Up to 10 years of follow-up]
  • Simple Endoscopic Score for Crohn's Disease (SES-CD) [Time frame: Up to 10 years of follow-up]
  • Short Inflammatory Bowel Disease Questionnaire (SIBDQ) [Time frame: Up to 10 years of follow-up]
  • PROMIS-10 Global Health Score [Time frame: Up to 10 years of follow-up]
  • Bowel Urgency Score [Time frame: Up to 10 years of follow-up]
  • Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) [Time frame: Up to 10 years of follow-up]
Secondary outcome measures (3)
  • Change in Disease activity over time [Time frame: Up to 10 years of follow-up]
  • Treatment persistence (drug persistence) [Time frame: Up to 10 years of follow-up]
  • Incidence of adverse events and serious adverse events [Time frame: Up to 10 years of follow-up]

Eligibility criteria

Inclusion criteria

  • Crohn Disease Ulcerative Colitis Indterminate Colitis

Exclusion criteria

  • Other gastrointestinal disorders than above

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Germany · 1 center
  • ImmunoRegister gUG — Hamburg

Identifiers

NCT: NCT07319442 · HW-PV5539

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗