A Study to Generate Real-world Evidence of Guselkumab Effectiveness in Inflammatory Bowel Disease in Germany
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJanssen-Cilag G.m.b.H
About this trial
The purpose of this study is to characterize participants with Crohn's Disease (CD) and Ulcerative Colitis (UC) treated with Guselkumab in a real-world setting, and to assess the clinical effectiveness (how well the treatment works) in the overall population and in different participant subgroups. Furthermore patient-reported outcomes like fatigue, health-related quality of life (HRQoL), sexuality, work productivity and activity as well as treatment satisfaction will be assessed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be eligible for biologic treatment and initiate guselkumab according to the approved indications as described in the current version of the summary of product characteristics
Signed informed consent form is available, allowing data collection and source data verification in accordance with local requirements
By judgement of the treating physician, the participant is able and willing to complete the patient-reported outcome(s) (PROs) assessments for the duration of the study
Disqualifiers
Has a history of more than 4 lines of advanced inflammatory bowel disease (IBD) therapy
Has been previously exposed to interleukin (IL)-23 inhibitors. As an exception, participants with history of ustekinumab exposure may be included
Has had a colectomy and/or a pouch
Is currently enrolled in an interventional clinical study or another non-interventional study from Janssen or Johnson & Johnson (J&J)
Trial population
The study population will include participants with confirmed diagnosis of moderate-to-severe Crohn's disease (CD) or Ulcerative colitis (UC) disease.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
500 Participants
are grouped into 1 trial groupGroup A: Group 1: Moderate-to-Severe Ulcerative Colitis (UC) or Crohn's Disease (CD)
Trial outcomes
Primary outcomes
1
Percentage of Participants Achieving Clinical Remission for Crohn's Disease (CD) as Measured by Harvey-Bradshaw Index (HBI)
Clinical remission for CD is defined as the HBI score less than or equal to (\<=) 4. HBI score is used to assess disease severity and treatment effectiveness.
Time frame
Week 482
Percentage of Participants Achieving Clinical Remission for Ulcerative Colitis (UC) as Measured by Partial Mayo Score (PMS)
Clinical remission for UC is defined as the PMS score \<=2 and a rectal bleeding subscore of 0. Mayo scoring system is used to assess disease severity and treatment effectiveness.
Time frame
Week 48Secondary outcomes
1
Time to Guselkumab Discontinuation
Time to guselkumab discontinuation (treatment persistency) will be reported.
Time frame
Up to Week 962
Change in Stool Frequency Within the First 4 Weeks of Guselkumab Administration
Change in stool frequency for participants will be asked, that is, how many bowel movements they had in last 24 hours, how many of those were very soft or liquid, or how many has occurred during the night.
Time frame
Up to Week 43
Change in Rectal Bleeding Within First 4 Weeks of Guselkumab Administration
Change in rectal bleeding for participants will be asked, that is, how severe were the rectal bleedings in the last 24 hours.
Time frame
Up to Week 44
Change in Abdominal Pain Within the First 4 Weeks of Guselkumab Administration
Change in abdominal pain for participants will be asked, that is, how severe was the abdominal pain in the last 24 hours.
Time frame
Up to Week 4Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov