NCT04032756

Tofacitinib Registry of Patients With Ulcerative Colitis in Germany

Tofacitinib Registry of Patients With Ulcerative Colitis in Germany - Documentation of Tofacitinib Induction and Maintenance Therapy in Conjunction With Long-term Outcome and Predictors of Response

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Ced Service GmbH · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

Summary

This registry on Tofacitinib and biologics (anti-integrin/anti-TNF) in the treatment of ulcerative colitis (UC) patients in Germany will extend the prospective documentation of safety issues and efficacy in induction and maintenance therapy of Tofacitinib (Xeljanz®) in addition to other biologics used in Germany with a particular interest in predictors of long-term responses and favorable disease outcome or to predict severe side effects caused by therapy with Januskinase(JAK)- inhibitors/biologics.

Detailed description

This is an Investigator-initiated non-randomized, non-interventional observational prospective long- term research (IIR) as part of the normal treatment of UC patients for the safety and efficacy of Tofacitinib / biologic therapies. As of 01st July 2019, UC patients who have been provided Tofacitinib / biologics for UC according the respective label by the treating physician may be prospectively included in an online database by the participating study centers by 31st March 2021. An interim analysis is planned at the end of patients ́ recruitment with respect of the induction phase (week 16) for October 2021 with a first publication of the data in a peer-reviewed journal (e.g., JCC, GUT, UEG Journal). Up to 480 patients (including about 360 UC patients with Tofacitinib and about 120 UC patients with biologics) will be included in the online documentation. A specification to the study centers regarding the group inclusion (patients treated with Tofacitinib (group 1) or a biologics (group 2)) will not be made; this means, each study center can include patients in both groups. The CED Service GmbH assume that approximately 20-30% of Tofacitinib patients will be biologic-naïve UC patients, many of whom will represent early disease patients (\< 2 years after first diagnosis).

Conditions

• Colitis, Ulcerative
• Biologics
• Tofacitiniib
• Chronic Inflammatory Small Bowel Disease
• Bowel Diseases, Inflammatory
• Bowel Disease
• CED

Timeline

• Start date: 2019-08-01
• Primary completion: 2020-11-15
• Completion: 2020-11-15
• First posted: 2019-07-25
• Last updated: 2021-10-08

Locations

1 site across 1 country: Germany