Clinical trial NCT04032756: Tofacitinib Registry of Patients With Ulcerative Colitis in Germany
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colitis, Ulcerative
Biologics
Tofacitiniib
Chronic Inflammatory Small Bowel Disease
Bowel Diseases, Inflammatory
Bowel Disease
CED
Lead sponsor: Ced Service GmbH
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2019-07-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Up to 480 patients (aged 18-80 years at enrollment) (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).

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).

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

Primary outcomes:
measure: partial Mayo score ≤ 1 plus a bleeding subscore of 0) in the inductionphase (week 16)
timeFrame: 07/01/2019 - 03/31/2023
Secondary outcomes:
measure: occurrence of serious side effects (e.g., death, tumor, tuberculosis, severe infections, or side effects leading to hospitalization)
timeFrame: 07/01/2019 - 03/31/2023
measure: 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
timeFrame: 07/01/2019 - 03/31/2023
measure: hospitalization days via question in questionnaire
timeFrame: 07/01/2019 - 03/31/2023
measure: psychosocial impairments - EQ-5D
timeFrame: 07/01/2019 - 03/31/2023
measure: EQ-5D quality of life
timeFrame: 07/01/2019 - 03/31/2023
measure: early retirement via question in questionnaire
timeFrame: 07/01/2019 - 03/31/2023
Other outcomes:
Locations:
city: Minden
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Minden
state: Niedersachsen
Study officials:
References: