Crohn Disease (CD), Indeterminate Colitis, Ulcerative Colitis (UC)
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
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.
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.
Interventions
None listed
Sponsors
ImmunoRegister gUG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Crohn Disease Ulcerative Colitis Indterminate Colitis
Exclusion criteria
* Other gastrointestinal disorders than above
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) | 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. |
| Short Inflammatory Bowel Disease Questionnaire (SIBDQ) | 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 | 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 | 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. |
| Crohn's Disease Activity Index (CDAI) | 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 | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment persistence (drug persistence) | 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. |
| Incidence of adverse events and serious adverse events | 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. |
| Change in Disease activity over time | 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. |
Countries
Germany
Contacts
Primary ContactStefanie Howaldt, MD
Outcome results
None listed