CEDUR - German IBD Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorImmunoRegister gUG
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Crohn Disease Ulcerative Colitis Indterminate Colitis
Disqualifiers
Other gastrointestinal disorders than above
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 10 years of follow-up2
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.
Time frame
Up to 10 years of follow-up3
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.
Time frame
Up to 10 years of follow-up4
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.
Time frame
Up to 10 years of follow-upSecondary outcomes
1
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.
Time frame
Up to 10 years of follow-up2
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.
Time frame
Up to 10 years of follow-up3
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.
Time frame
Up to 10 years of follow-upSponsors and contacts
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Source ClinicalTrials.gov