CEDUR - German IBD Registry

NCT07319442 | Recruiting

• 1 other identifier: HW-PV5539
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ulcerative Colitis (UC); Indeterminate Colitis; Crohn Disease (CD)

Keywords

IBD; Registry; Crohn's disease; Ulcerative Colitis; Real-world-data; Germany; Quality of care; pharmaeconomics; safety; long-term follow-up; patient journey; treatment algorithm

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (3)

• Change in Disease activity over time

  Up to 10 years of follow-up

• Treatment persistence (drug persistence)

  Up to 10 years of follow-up

• Incidence of adverse events and serious adverse events

  Up to 10 years of follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Crohn Disease Ulcerative Colitis Indterminate Colitis

You may not qualify if:

• Other gastrointestinal disorders than above

Sponsors & Collaborators

• ImmunoRegister gUG: lead

Study Sites (1)

ImmunoRegister gUG

Hamburg, 20251, Germany

RECRUITING

Related Links

• Official website of the sponsor organization ImmunoRegister gUG.

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Stefanie Howaldt, MD

  ImmunoRegister gUG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefanie Howaldt, MD

CONTACT

+4940423265150; Howaldt@immunoregister.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: January 6, 2026
• Study Start: May 3, 2018
• Primary Completion (Estimated): May 1, 2036
• Study Completion (Estimated): May 1, 2036
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)