Tofacitinib Registry of Patients With Ulcerative Colitis in Germany

NCT04032756

Last updated date
Study Location
Gastroenterologische Gemeinschaftspraxis Minden
Minden, Niedersachsen, 32423, Germany
Contact
0431-5929575600

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ulcerative Colitis, Biologics, Tofacitiniib, Chronic Inflammatory Small Bowel Disease, Inflammatory Bowel Diseases, Bowel Disease, CED
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-80 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with moderate to severe Ulcerative Colitis aged 18-80 years at enrollment

- Written informed consent is given

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Malignant disease in history (except for non-melanoma skin cancer)


- Any contraindication according to the SmPC of the respective medication

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Ulcerative Colitis, Biologics, Tofacitiniib, Chronic Inflammatory Small Bowel Disease, Inflammatory Bowel Diseases, Bowel Disease, CEDTofacitinib Registry of Patients With Ulcerative Colitis in Germany
NCT04032756
  1. Minden, Niedersachsen
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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-nai?ve 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-nai?ve 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[email protected]
Contact: Karen Schmidt, M.Sc.0431-5929575335[email protected]
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