Effectiveness of Ustekinumab in Induction and Maintenance Therapy of ulcerative colitis (RUN-UC)

• Conditions: K51; Ulcerative colitis

• Registration Number: DRKS00022043
• Lead Sponsor: CED Service GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 507

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

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.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical remission (defined as: partial mayo score =1 plus a bleeding subscore =0) at the end of the induction phase (week 16)

Secondary Outcome Measures

Name	Time	Method
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):<br>- clinical remission<br>- the steroid-free remission<br>- symptomatic remission (pMayo score without PGA)<br>- of clinical response (Partial Mayo Score reduction of =3 accompanied by a reduction of at least 30% compared to baseline)<br>- the quality of life (EQ-5D)