Ulcerative Colitis (UC)CEDURNCT07319442
CEDUR - German IBD Registry
An observational study of Ulcerative Colitis (UC) and Indeterminate Colitis, run by ImmunoRegister gUG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis (UC), Indeterminate Colitis, Crohn Disease (CD)
- How many people
- 10,000 participants
- Where
- 1 siteGermany
- Study dates
- 3 May 2018to May 2036
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Crohn Disease Ulcerative Colitis Indterminate Colitis
Who cannot join
- Other gastrointestinal disorders than above
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
ImmunoRegister gUG
Hamburg, 20251
Stefanie Howaldt, MD, +4930423265150, Howaldt@immunoregister.de
About this study
Official title: 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.
Read the 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.
- 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
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 10 years of follow-up
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to 10 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start3 May 2018
- Primary completionMay 2036 (estimated)
- Study completionMay 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- ImmunoRegister gUG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefanie Howaldt, MD, Principal investigator, ImmunoRegister gUG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319442
- Sponsor's protocol ID
- HW-PV5539
- Acronym
- CEDUR
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Observation of IBD Patients, a Nationwide German IBD Registry "CEDUR"
- ClinicalTrials.gov ID
- NCT07319442
- Acronym / sponsor ID
- CEDUR / HW-PV5539
- Keywords
- IBD, Registry, Crohn's disease, Ulcerative Colitis, Real-world-data, Germany, Quality of care, pharmaeconomics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- ImmunoRegister gUGUniversity, hospital or other
- Study start
- 3 May 2018 (actual)
- Primary completion
- May 2036 (estimated)
- Study completion
- May 2036 (estimated)
- First posted
- 6 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Crohn Disease Ulcerative Colitis Indterminate Colitis
Key exclusion criteria (1 listed)
- Other gastrointestinal disorders than above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Official website of the sponsor organization ImmunoRegister gUG.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefanie Howaldt, MD principal investigator
ImmunoRegister gUG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis (UC) and Indeterminate Colitis, run by ImmunoRegister gUG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stefanie Howaldt, MD (+4940423265150, Howaldt@immunoregister.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crohn's Disease Activity Index (CDAI) (time frame: Up to 10 years of follow-up). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.