Tofacitinib Registry of Patients With Ulcerative Colitis in Germany

NCT ID: NCT04032756

Last Updated: 2021-10-08

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2020-11-15

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

UC-patients (age at enrollment: 18-80 years) receiving a newly introduced Tofacitinib therapy (n=360). Previous treatment(s) with biologics or immunosuppressants is (are) permitted. About 20-30% of the Tofacitinib patients will biologic-naiv.

No interventions assigned to this group

Group 2

UC-patients (age at enrollment: 18-80 years) receiving a newly introduced biologics therapy (n=120). Previous treatment(s) with biologics or immunosuppressants is (are) allowed.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients with moderate to severe Ulcerative Colitis aged 18-80 years at enrollment
• Written informed consent is given

Exclusion Criteria

• Malignant disease in history (except for non-melanoma skin cancer)
• Any contraindication according to the SmPC of the respective medication

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Ced Service GmbH

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gastroenterologische Gemeinschaftspraxis Minden

Minden, Lower Saxony, Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

Protocol V1.4 31.05.2019

Identifier Type: -

Identifier Source: org_study_id