Trial · NCT06788340
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The fraction of patients in steroid-free remission | at the end of the observation period (48 weeks) | ((for CD defined by PRO2 ≤ 4, for UC defined by PRO2 = 0) AND a fecal calprotectin ≤200) |
| Secondary | The fraction of the observation period (48 weeks) where the disease is in steroid-free remission | this is registered every 4th week throughout the study duration of 48 weeks. | for CD defined by patient reported outcome 2 (PRO2) stool frequency \<= 3 and abdominal pain \< = 1, for UC defined by PRO2, number of abnormal stools for the patient, bleeding from the rectum = 0) AND a fecal calprotectin ≤ 200. |
| Secondary | The financial costs associated with the two treatment strategies over the observation period (12 months) | through study completion, an average of 48 weeks | expenditure on medicines (both expenditure on the purchase of medicines and expenditure on the administration of medicines), expenses for doctor visits / visits to a nurse, possibly expenses for hospitalization, possibly expenses for surgery, possibly expenses for sick leave and possibly expenses for early retirement. After end of study, the investigators will collect data on sick leave etc. from the national patient registry. |
| Secondary | Endoscopic healing of the mucosa | at completion of study, approximately 48 weeks | for CD assessed by Simple Endoscopic Score for Crohn's Disease (SES-CD) \<3; and for UC assessed on the basis of the Ulcerative Colitis Endoscopic Index of Severity (UCEIS)≤1. If disease is primarily located in the small intestine, MRI or capsule endoscopy will be used instead, and assessed by the simplified MaRIA score \<1 or Lewis score ≤135, respectively |
| Secondary | Changes in quality of life during the study period | 48 weeks | assessed by Short Inflammatory Bowel Disease Questionnaire (SIBDQ) difference between baseline and end of study. Improvement of quality of life indicated by a positive change of the SIBDQ. SIBDQ is collected at inclusion, week 24 and week 48. A higher the score, indicates a better outcome, Maksimum score of 70 points. |
| Secondary | Quality of life as QALYs | 48 weeks | assessed by the EuroQol-5 dimensions-5 levels questionnaire (EQ-5D-5L) and converted to QALYs. The cost per QALY will also be calculated. EQ-5D-5L is collected every 8th week throughout the study. Score ranges from 5-25, a higher score indicating poorer quality of life. |
| Secondary | Clinical Disease Activity | 48 weeks | assessed by Simplified Clinical Colitis Activity Index (SCCAI) for UC and Harvey-Bradshaw Index (HBI) for CD. These are collected at inclusion and every 24th week thereafter. SCCAI score ranges from 0-19, a higher score indicating a more severe disease activity. HBI score ranges from 0-20, a higher score indicating more severe disease activity. |
| Secondary | Inflammatory burden over the observational period | 48 weeks | CRP, albumin, hemoglobin, leukocyte counts and fecal calprotectin. These will be collected every 4th week |
| Secondary | Expenses for analysis of drug concentration | 48 weeks | patients will have drug concentrations analyzed every 4th week, the price of this will be collected |
| Secondary | Expenses for drugs | 48 weeks | patients will typically administer sc VDZ every 4th to 2nd week, iv VDZ every 12th to 4th week and UST every 12th to 4th week |
| Secondary | Drug persistency | 48 weeks | number of patients switching to another treatment during the study |
| Secondary | Disease flares | 48 weeks | assessed by consumption of glucocorticoids or IBD-related surgery |
| Secondary | Fatigue | 48 weeks. | to assess if treating according to a PK-model results in less fatigue measured by Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F). Patients are asked to register how fatigued they feel every 4th week throughout the study. The VAS-F is a visual analogue scale that goes from 0-10, 10 indicating severe fatigue. |
| Secondary | Disease impact on work productivity and performance of daily activities | 48 weeks | Assessed by difference in Work Productivity and Activity Impairment questionnaire (WPAI) scores and changes in scores between patients in the intervention- and control group. WPAI is collected at inclusion and every 24th week throughout the study. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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