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Trial record 1 of 1 for:    NCT04032756
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Tofacitinib Registry of Patients With Ulcerative Colitis in Germany (TOFA-UC)

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ClinicalTrials.gov Identifier: NCT04032756
Recruitment Status : Recruiting
First Posted : July 25, 2019
Last Update Posted : February 18, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Ced Service GmbH

Tracking Information
First Submitted Date July 19, 2019
First Posted Date July 25, 2019
Last Update Posted Date February 18, 2020
Actual Study Start Date August 1, 2019
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 23, 2019)
partial Mayo score ≤ 1 plus a bleeding subscore of 0) in the inductionphase (week 16) [ Time Frame: 07/01/2019 - 03/31/2023 ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 23, 2019)
  • occurrence of serious side effects (e.g., death, tumor, tuberculosis, severe infections, or side effects leading to hospitalization) [ Time Frame: 07/01/2019 - 03/31/2023 ]
    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)
  • 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 [ Time Frame: 07/01/2019 - 03/31/2023 ]
    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.
  • hospitalization days via question in questionnaire [ Time Frame: 07/01/2019 - 03/31/2023 ]
    Obtaining health economic data in UC patients on Tofacitinib / biologics therapy (hospitalization)
  • psychosocial impairments - EQ-5D [ Time Frame: 07/01/2019 - 03/31/2023 ]
    Obtaining data of the course from UC patients with a new therapy (Tofacitinib / biologics) related to treatment strategy and psychosocial impairments
  • EQ-5D quality of life [ Time Frame: 07/01/2019 - 03/31/2023 ]
    Obtaining health economic data in UC patients on Tofacitinib / biologics therapy (quality of life)
  • early retirement via question in questionnaire [ Time Frame: 07/01/2019 - 03/31/2023 ]
    Obtaining health economic data in UC patients on Tofacitinib / biologics therapy (early retirement)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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).

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
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).

Condition
  • Colitis, Ulcerative
  • Biologics
  • Tofacitiniib
  • Chronic Inflammatory Small Bowel Disease
  • Bowel Diseases, Inflammatory
  • Bowel Disease
  • CED
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 23, 2019)
480
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2023
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Sina Franzenburg, M.Sc. 0431-5929575600 s.franzenburg@kompetenznetz-ced.de
Contact: Karen Schmidt, M.Sc. 0431-5929575335 k.schmidt@kompetenznetz-ced.de
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT04032756
Other Study ID Numbers Protocol V1.4 31.05.2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Ced Service GmbH
Study Sponsor Ced Service GmbH
Collaborators Pfizer
Investigators Not Provided
PRS Account Ced Service GmbH
Verification Date February 2020