K51
Conditions
Interventions
Group 1: CU patients starting a new ustekinumab therapy (n=250).
Group 2: CU patients starting a new anti-TNF-alpha/anti-integrin/small molecule therapy other than ustekinumab (n=350).
Sponsors
CED Service GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients who, according to the doctor's decision, are to be treated with Ustekinumab or another biologic or Tofacitinib. - Ulcerative colitis patients between the ages of 18 and 80 at inclusion. - In-label use according to the summary of product characteristics of the respective medication.
Exclusion criteria
Exclusion criteria: Planned surgical intervention with hospitalization. - Malignant disease in history (except "Non-Melanoma Skin Cancer"). - All contraindications according to the summary of product characteristics of the respective medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical remission (defined as: partial mayo score =1 plus a bleeding subscore =0) at the end of the induction phase (week 16) | — |
Secondary
| Measure | Time frame |
|---|---|
| Investigation of Real world efficacy during (week 8) and at the end of the induction phase (week 16) and during the course of the disease (after 6 months, as well as after 1 and 3 years) in biologics-experienced and -naïve CU patients - with ustekinumab and other CU therapies (i.e. ustekinumab, vedolizumab, anti-TNF-alpha and tofacitinib (the latter only in biologics-pretreated patients): - clinical remission - the steroid-free remission - symptomatic remission (pMayo score without PGA) - of clinical response (Partial Mayo Score reduction of =3 accompanied by a reduction of at least 30% compared to baseline) - the quality of life (EQ-5D) | — |
Countries
Germany
Contacts
Public ContactSamantha Fajardo Salmon
CED Service GmbH
Outcome results
None listed