CEDUR - German IBD Registry (CEDUR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Indeterminate Colitis; Crohn Disease (CD); Ulcerative Colitis (UC)

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.

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Stefanie Howaldt, MD; Phone Number: +4940423265150; Email: Howaldt@immunoregister.de

Study Locations

• Germany
  • Hamburg, Germany, 20251
    • Recruiting
    • ImmunoRegister gUG
    • Contact: Stefanie Howaldt, MD; Phone Number: +4930423265150; Email: Howaldt@immunoregister.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) with a confirmed diagnosis of Crohn's disease, ulcerative colitis, or indeterminate colitis who receive routine medical care in Germany. Patients are recruited by participating gastroenterologists in hospitals and private practices and are followed prospectively within the CEDUR registry for long-term observation of disease course, treatment patterns, safety, and quality of life.

Description

Inclusion Criteria:

• Crohn Disease Ulcerative Colitis Indterminate Colitis

Exclusion Criteria:

• Other gastrointestinal disorders than above

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crohn's Disease Activity Index (CDAI)	The Crohn's Disease Activity Index (CDAI) is a composite clinical score assessing disease activity in patients with Crohn's disease. It incorporates eight variables including stool frequency, abdominal pain, general well-being, extraintestinal manifestations, and laboratory parameters. Scores range from 0 to approximately 600, with higher scores indicating greater disease activity.	Up to 10 years of follow-up
Partial Mayo Score	The Partial Mayo Score is a clinical index used to assess disease activity in ulcerative colitis. It includes stool frequency, rectal bleeding, and physician's global assessment, with scores ranging from 0 to 9. Higher scores indicate more severe disease activity.	Up to 10 years of follow-up
Mayo Score (Full Mayo Score)	The Mayo Score is a composite index used to assess disease activity in ulcerative colitis. It consists of four components: stool frequency, rectal bleeding, physician's global assessment, and endoscopic findings. Total scores range from 0 to 12, with higher scores indicating more severe disease activity.	Up to 10 years of follow-up
Simple Endoscopic Score for Crohn's Disease (SES-CD)	The Simple Endoscopic Score for Crohn's Disease (SES-CD) is an endoscopic index used to quantify mucosal disease activity in Crohn's disease. It assesses ulcer size, ulcerated surface, affected surface, and presence of strictures across bowel segments. Higher scores indicate more severe endoscopic disease activity.	Up to 10 years of follow-up
Short Inflammatory Bowel Disease Questionnaire (SIBDQ)	The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) is a validated patient-reported outcome measure assessing health-related quality of life in patients with inflammatory bowel disease. It consists of 10 items covering bowel, systemic, emotional, and social domains. Total scores range from 10 to 70, with higher scores indicating better quality of life.	Up to 10 years of follow-up
PROMIS-10 Global Health Score	The PROMIS-10 Global Health is a validated patient-reported outcome measure assessing global physical and mental health. It consists of 10 items generating physical and mental health summary scores standardized to a T-score metric. Higher scores indicate better self-reported health status.	Up to 10 years of follow-up
Bowel Urgency Score	The Bowel Urgency Score is a patient-reported measure assessing the severity and frequency of urgency to defecate. The range is from 0-10. Higher scores indicate greater bowel urgency and symptom burden.	Up to 10 years of follow-up
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)	The Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) is a validated patient-reported outcome measure assessing fatigue and its impact on daily functioning in patients with chronic illness. It consists of 13 items, with total scores ranging from 0 to 52. Higher scores indicate less fatigue and better functional status.	Up to 10 years of follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Disease activity over time	Effectiveness of inflammatory bowel disease therapies will be assessed by longitudinal changes in validated disease activity indices, including clinical, endoscopic, and patient-reported outcome measures, during registry follow-up.	Up to 10 years of follow-up
Treatment persistence (drug persistence)	Treatment persistence is defined as the duration of continuous therapy from initiation to discontinuation or switch of treatment for any reason during registry follow-up.	Up to 10 years of follow-up
Incidence of adverse events and serious adverse events	Safety will be assessed by the frequency, type, and severity of adverse events (AEs) and serious adverse events (SAEs) reported by participating physicians during registry follow-up.	Up to 10 years of follow-up

Collaborators and Investigators

• Sponsor: ImmunoRegister gUG
• Investigators: Principal Investigator: Stefanie Howaldt, MD, ImmunoRegister gUG

Publications and helpful links

Helpful Links

• Official website of the sponsor organization ImmunoRegister gUG.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2018
• Primary Completion (Estimated): May 1, 2036
• Study Completion (Estimated): May 1, 2036

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: December 21, 2025
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: December 21, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: safety; Ulcerative Colitis; Registry; IBD; Crohn's disease; long-term follow-up; Germany; Quality of care; patient journey; treatment algorithm; Real-world-data; pharmaeconomics
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Crohn Disease
• Other Study ID Numbers: HW-PV5539

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because the registry collects pseudonymized patient information under strict data protection regulations (GDPR) in Germany. Data are available only in anonymized and aggregated form for approved scientific analyses conducted by the Scientific Advisory Committee.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No