Ulcerative Colitis Clinical Trial
Official title:
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05702879 -
Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success
|
||
Not yet recruiting |
NCT05953402 -
A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring
|
||
Recruiting |
NCT05316584 -
A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy
|
N/A | |
Recruiting |
NCT03950232 -
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
|
Phase 3 | |
Completed |
NCT03124121 -
Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels
|
Phase 4 | |
Not yet recruiting |
NCT06100289 -
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
|
Phase 3 | |
Withdrawn |
NCT04209556 -
A Study To Evaluate The Safety And Efficacy Of PF-06826647 In Participants With Moderate To Severe Ulcerative Colitis
|
Phase 2 | |
Terminated |
NCT00061282 -
Clotrimazole Enemas for Pouchitis in Children and Adults
|
Phase 1/Phase 2 | |
Recruiting |
NCT04398550 -
SCD vs. Mediterranean Diet Therapy in Ulcerative Colitis
|
N/A | |
Recruiting |
NCT04314375 -
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis
|
Phase 4 | |
Active, not recruiting |
NCT04857112 -
Study Evaluating Efficacy and Safety of Amiselimod (MT-1303) in Mild to Moderate Ulcerative Colitis
|
Phase 2 | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Active, not recruiting |
NCT04033445 -
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
|
Phase 2/Phase 3 | |
Recruiting |
NCT05428345 -
A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
|
||
Active, not recruiting |
NCT06221995 -
Energy Expenditure in Patients With Ulcerative Colitis Undergoing Surgery
|
||
Recruiting |
NCT04767984 -
Testing Atorvastatin to Lower Colon Cancer Risk in Longstanding Ulcerative Colitis
|
Phase 2 | |
Completed |
NCT02508012 -
Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases
|
N/A | |
Recruiting |
NCT06071312 -
FMT in Patients With Recurrent CDI and Ulcerative Colitis: Single Infusion Versus Sequential Approach
|
Phase 1/Phase 2 | |
Completed |
NCT03760003 -
Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis
|
Phase 2 | |
Not yet recruiting |
NCT05539625 -
Mini-MARVEL - Mitochondrial Antioxidant Therapy in Ulcerative Colitis
|
Phase 2 |