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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04032756
Other study ID # Protocol V1.4 31.05.2019
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date August 1, 2019
Est. completion date November 15, 2020

Study information

Verified date September 2021
Source Ced Service GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Terminated
Enrollment 50
Est. completion date November 15, 2020
Est. primary completion date November 15, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Locations

Country Name City State
Germany Gastroenterologische Gemeinschaftspraxis Minden Minden Niedersachsen

Sponsors (2)

Lead Sponsor Collaborator
Ced Service GmbH Pfizer

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary partial Mayo score = 1 plus a bleeding subscore of 0) in the inductionphase (week 16) The primary endpoint is steroid-free remission (remission: partial Mayo score = 1 plus a bleeding subscore of 0) in the inductionphase (week 16). For this endpoint it will be only captured if there is a current use of steroids at the time of the visit. So the patient will be asked for current steroid use at time of visit at week 16 and if he has received steroids within the last 4 weeks prior to time point of the visit. 07/01/2019 - 03/31/2023
Secondary occurrence of serious side effects (e.g., death, tumor, tuberculosis, severe infections, or side effects leading to hospitalization) Online documentation of safety and efficacy in induction and maintenance therapy including the occurrence of serious side effects (e.g., death, tumor, tuberculosis, severe infections, or side effects leading to hospitalization) 07/01/2019 - 03/31/2023
Secondary response: partial Mayo Score reduction of = 3 accompanied by a decrease of at least 30% from baseline and remission: partial Mayo score = 1 plus a bleeding subscore of 0 - Efficacy Efficacy (response: partial Mayo Score reduction of = 3 accompanied by a decrease of at least 30% from baseline and remission: partial Mayo score = 1 plus a bleeding subscore of 0) of induction therapy (week 8 and 16) and maintenance therapy (months 6 to 24) and efficacy (response and remission) in different subpopulations, e.g. based on a previous biologic therapy or not. 07/01/2019 - 03/31/2023
Secondary hospitalization days via question in questionnaire Obtaining health economic data in UC patients on Tofacitinib / biologics therapy (hospitalization) 07/01/2019 - 03/31/2023
Secondary psychosocial impairments - EQ-5D Obtaining data of the course from UC patients with a new therapy (Tofacitinib / biologics) related to treatment strategy and psychosocial impairments 07/01/2019 - 03/31/2023
Secondary EQ-5D quality of life Obtaining health economic data in UC patients on Tofacitinib / biologics therapy (quality of life) 07/01/2019 - 03/31/2023
Secondary early retirement via question in questionnaire Obtaining health economic data in UC patients on Tofacitinib / biologics therapy (early retirement) 07/01/2019 - 03/31/2023
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