CEDUR - German IBD Registry (CEDUR)

December 21, 2025 updated by: ImmunoRegister gUG

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Crohn's Disease Activity Index (CDAI)
Time Frame: Up to 10 years of follow-up
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
Time Frame: Up to 10 years of follow-up
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)
Time Frame: Up to 10 years of follow-up
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)
Time Frame: Up to 10 years of follow-up
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)
Time Frame: Up to 10 years of follow-up
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
Time Frame: Up to 10 years of follow-up
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
Time Frame: Up to 10 years of follow-up
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)
Time Frame: Up to 10 years of follow-up
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Disease activity over time
Time Frame: Up to 10 years of follow-up
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)
Time Frame: Up to 10 years of follow-up
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
Time Frame: Up to 10 years of follow-up
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ImmunoRegister gUG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stefanie Howaldt, MD, ImmunoRegister gUG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2036

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2036

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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