K50.9 K51.9
Conditions
Interventions
Group 1: Molecular Medicine Arm
Group 2: Best Care Arm
Sponsors
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - The patient gave written consent to the study - Diagnosis of CD/UC confirmed since 3 months - Active moderate-to-severe disease despite medication with 5-ASA, budesonide (max 9mg/d), and/or other immunosuppressants like AZA, 6-MP and MTX o CD: CDAI 221-450 (or PRO2 14-34), CDEIS = 6 with Ulcers in min. 1 segment o UC: Mayo-Score = 6 with Bleeding/diarrhea score of each = 2 and endoscopic mayo score = 2 - Indication for i.v. anti-TNF therapy and completed shared therapy decision through treating physician/patient - Patient is Biologics/JAK inbibitor naive - If anti-inflammatory medication is taken: o Dosing within the respective indication (Mesalamine/5-ASA, sulfasalazine, azathioprine, 6-mercaptopurine, methotrexate) o Prednisolone max. 20mg/d at inclusion
Exclusion criteria
Exclusion criteria: - Other diagnosis or causes of intestinal inflammation, like indeterminate colitis, microscopic colitis, infectious colitis, ischemic colitis, radiation-induced colitis - Prior peri-interventional complications in endoscopic assessments - Patient does not understand the study or is not able to attend the scheduled visits - Hemoglobin levels <10 g/dl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease control: conbined clinical, endoscopic and biochemical remission | — |
Secondary
| Measure | Time frame |
|---|---|
| (i) Clinical Remission ((CDAI) 4 weeks, IBD-related surgery and hospitalization (vii) steroid-free remission (viii) IFX dosing | — |
Countries
Germany
Contacts
Public ContactSabrina Fritz
Universitätsklinikum Schleswig-Holstein, Campus Kiel
Outcome results
None listed