Tofacitinib Registry of Patients With Ulcerative Colitis in Germany

NCT04032756 | Terminated

• 1 other identifier: Protocol V1.4 31.05.2019
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• occurrence of serious side effects (e.g., death, tumor, tuberculosis, severe infections, or side effects leading to hospitalization)

  07/01/2019 - 03/31/2023

• 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

  07/01/2019 - 03/31/2023

• hospitalization days via question in questionnaire

  07/01/2019 - 03/31/2023

• psychosocial impairments - EQ-5D

  07/01/2019 - 03/31/2023

• EQ-5D quality of life

  07/01/2019 - 03/31/2023

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ced Service GmbH: lead
• Pfizer: collaborator

Study Sites (1)

Gastroenterologische Gemeinschaftspraxis Minden

Minden, Lower Saxony, 32423, Germany

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases; Intestinal Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 25, 2019
• Study Start: August 1, 2019
• Primary Completion: November 15, 2020
• Study Completion: November 15, 2020
• Last Updated: October 8, 2021

Record last verified: 2021-09

Locations

DE (1)