Crohn's disease K50
Conditions
Interventions
Group 1: Retrospective multicenter chart review study with up to 20 sites (secondary use of existing health information)
Approx. 300 CD (Crohn disease) patients in Germany providing written informed c
AMG) Section 67 (6) as well as Good Pharmacoepidemiology Practices
Sponsors
Takeda GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patient has read, understood, and signed the informed consent form 2. Patient = 18 years old at informed consent 3. Patient has received medical care for moderately to severely active CD, including on-label therapy with VDZ, at the study site 4. Patient’s treatment with VDZ i.v. and/or s.c. according to label has been initiated between July 2019 and July 2024 (index date) 5. If patient has been treated by more than one hospital, hospital department, or practice, study site has complete access to patient records 6. Patient’s data include complete baseline information (previous treatment with anti-TNF, prior bowel surgery, prior fistulizing disease, level of albumin and concentration of C-reactive protein) required to calculate the VDZ-CDST score and baseline HBI 7. Patient’s data are available for a period of at least 14 months after the index date 8. All of the following datapoints should theoretically be available to include a patient in the study. However, to ease recruitment, a patient may be included if his/her data include valid HBI data at week 54 (+/- 2 weeks) as per the primary endpoint and at least half of these datapoints at the timepoints outlined in the protocol after baseline o information on clinical remission (HBI < 5), o information on steroid-free remission for patients on steroids at baseline (HBI < 5 and documented non-use of steroids at the visit analyzed), o HBI, o dosing scheme and mode of administration, o line of treatment (VDZ), o date of discontinuing VDZ (if applicable), o subsequent therapy for CD (if applicable), o information on CD related surgery (if applicable).
Exclusion criteria
Exclusion criteria: Not-meeting of any of the above mentioned inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CREM (clinical remission) rates at Week 54 in the three VDZ-CDST response probability categories. Measurement of CREM at week 54. Measurement via HBI (Harvey-Bradshaw Indes)-Score. | — |
Secondary
| Measure | Time frame |
|---|---|
| CREM rates at Week 30 in the three VDZ-CDST response probability categories. SF-CREM (steroid free clinical remission) rates at Week 30 in the three VDZ-CDST response probability categories. SF-CREM rates at Week 54 in the three VDZ-CDST response probability categories. Persistence at Week 14, 30, 38, 46, and 54 in the three VDZ-CDST response probability categories. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of VDZ-CDST in predicting the treatment response as measured by the aforementioned efficacy endpoints, with corresponding 95% CIs, for both VDZ-CDST cut-offs (low versus intermediate/high-probability group, and low/ intermediate versus high- probability group). Concordance index of CREM and SF-CREM at Week 30 and 54. | — |
Countries
Germany
Contacts
Public ContactStefan Schreiber
UKSH Kiel
Outcome results
None listed