TARGET Registry A Project of the German Network for Intestinal Diseases in Cooperation With Other Corporate Partners (TARGET)

TARGET Registry A Project of the German Network for Intestinal Diseases in Cooperation With the German Association of Gastroenterologists in Private Practice (Bng) and Other Corporate Partners

By capturing possible or known risk factors, it will be possible to recognize connections between these risk factors and the disease, thus obtaining valuable insights into the cause of the disease. This in turn facilitates an improved evaluation of the treatment situation as well as influencing future framework conditions for preventive measures and planning treatments. Disease registries are thus crucial for the planning and structuring of health policies.

The present registry protocol serves as a basis for the proper implementation of a registry for patients with chronic inflammatory bowel diseases. It describes the study rationale, objectives, design, participant groups, procedures and evaluation methods. Furthermore, it defines the responsibilities of each person involved in maintaining the registry and also forms the basis for decisions regarding evaluation by the Ethics Committee.

Study Overview

• Status: Not yet recruiting
• Conditions: Crohn Disease; Ulcerative Colitis; Indeterminate Colitis
• Intervention / Treatment: Other: No intervention, only standard care

Detailed Description

In view of the high prevalence and currently unsatisfactory treatment status, there is a significant medical demand for more effective treatment options. These require greater knowledge about the condition in the form of full disease progressions while exposed to a wide range of different treatment concepts and influencing factors. It has been possible to significantly increase scientific understanding of the pathogenesis of ulcerative colitis and Crohn's disease over the last few decades. Clinical and experimental results indicate a causal link with gastrointestinal barrier dysfunction and defective regulation of the immune system. However, no evidence has been found to prove that patients with the disease develop an immune deficiency by themselves, resulting in an increased susceptibility to bacterial or viral infections. Furthermore, there are unanswered questions concerning aetiology, risk factors and influencing factors for the early prediction of treatment responses.

The aim of this registry is to expand on previous findings in the field of diagnostic and therapeutic pathways for patients with Crohn's disease, ulcerative colitis and indeterminate colitis undergoing routine administration of a targeted therapy (biologics or another targeted therapy such as Janus kinase therapy) and various different treatment approaches. A data pool is to be generated for this purpose, in order to

• analyse disease progression
• systematize findings about treatment processes
• identify potential influencing factors
• review any new diagnostic procedures
• identify potential test subjects for further study
• evaluate the safety of various treatment concepts

A specific objective has not been defined for this registry as a registry does not per se need to build upon the foundation of a theoretically-deduced research hypothesis. Rather, it acts as a gateway for generating a systematic data repository.

The registry offers researchers the opportunity to formulate their own research hypotheses based on the collected data and to then use the generated data pool to attempt to test their hypothesis. Additional data/variables could also be collected as necessary in order to answer certain questions.

• Study Type: Observational
• Enrollment (Anticipated): 4400

Contacts and Locations

• Study Contact: Name: Sonja Buske; Phone Number: +49 4315929575371; Email: s.buske@kompetenznetz-ced.de
• Study Contact Backup: Name: Sandra Plachta-Danielzik, PD Dr.; Phone Number: +49 4315929575371; Email: splachta-danielzik@kompetenznetz-ced.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Any patient with a confirmed diagnosis of Crohn's disease, ulcerative colitis or indeterminate colitis who is undergoing a targeted therapy is a potential candidate for taking part in the registry.

Description

Inclusion Criteria:

1. Confirmed diagnosis of Crohn's disease or Confirmed diagnosis of ulcerative colitis or Confirmed diagnosis of indeterminate colitis (IBDU)
2. All types of treatment commensurate with the medical practice, independent of any study
3. Age 18-80
4. Ongoing or incipient targeted therapies with biologics and/or other targeted therapies (e.g. Janus kinase inhibitors)
5. Sufficient ability to communicate in German language
6. Patient must be able to recognize the nature, significance and scope of this registry and to act accordingly
7. Computer/Tablet/mobile phone with internet access

Exclusion Criteria:

1. No declaration of consent is given
2. Age < 18 and > 80

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Ongoing or incipient targeted therapies; Ongoing or incipient targeted therapies with biologics and/or other targeted therapies (e.g. Janus kinase inhibitors)

Other: No intervention, only standard care; The aim of this registry is to expand on previous findings in the field of diagnostic and therapeutic pathways for patients with Crohn's disease, ulcerative colitis and indeterminate colitis undergoing routine administration of a targeted therapy (biologics or another targeted therapy such as Janus kinase therapy) and various different treatment approaches. A data pool is to be generated for this purpose, in order to; analyse disease progression; systematize findings about treatment processes; identify potential influencing factors; review any new diagnostic procedures; identify potential test subjects for further study; evaluate the safety of various treatment concepts

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease activity	harvey bradshaw index	3 Years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life (QOL)	The Questioner EQ-5D is a standardized measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D expresses the state of health of the respondents in a one-dimensional measure from 0 (very poor) to 1 (best possible state of health).	3 Years
Use of glucocorticoids	Use of glucocorticoids	3 Years
Need for surgery	Need for surgery	3 Years
Occurrence of side effects and infections	Occurrence of side effects and infections	3 Years
Longevity of started treatments	Longevity of started treatments	3 Years

Collaborators and Investigators

• Sponsor: Ced Service GmbH
• Investigators: Study Director: Sandra Plachta-Danielzik, PD Dr., Kompetenznetz Darmerkrankungen

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2019
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 24, 2019

Study Record Updates

• Last Update Posted (Actual): July 29, 2019
• Last Update Submitted That Met QC Criteria: July 26, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases; Colitis
• Other Study ID Numbers: Version 1.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No