Trial · NCT06856031
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Drug retention rates analyzed at weeks 54 of vedolizumab treatment | at week 54 | the drug retention rate of vedolizumab |
| Primary | Drug retention rates analyzed at weeks 108 of vedolizumab treatment | at week 108 | the drug retention rate of vedolizumab |
| Secondary | Analyze the impact of baseline MES on VDZ drug retention rates | at week 54 and 108 | Analyze the difference in baseline MES between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment). The Mayo endoscopic score (MES) was used to assess the degree of intestinal inflammation, with a score of MES=0 defined as mucosal healing, MES=1 as mild, MES=2 as moderate, and MES=3 as severe. |
| Secondary | Analyze the impact of baseline disease sites on VDZ drug retention rates | at week 54 and 108 | Analyze the difference in disease sites between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment). Disease sites were categorized into proctitis (E1), left hemicolonitis (E2) and extensive colitis (E3) based on the Montreal UC phenotypic classification criteria. |
| Secondary | Analyze the impact of baseline modified Mayo score on VDZ drug retention rates | at week 54 and 108 | Analyze the difference in the baseline modified Mayo score between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment). The modified Mayo score was employed to assess UC disease activity. A modified Mayo score of ≤5 was defined as mild activity, 6-10 as moderate activity, and ≥11 as severe activity. |
| Secondary | Analyze the impact of duration of disease on VDZ drug retention rates | at week 54 and 108 | Analyze the difference in duration of disease (in years) between VDZ-continued group and VDZ-discontinued group. |
| Secondary | Analyze the impact of baseline C-reactive protein in peripheral blood on VDZ drug retention rates | at week 54 and 108 | Analyze the difference in baseline C-reactive protein (mg/L) in peripheral blood between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment). |
| Secondary | Analyze the impact of baseline erythrocyte sedimentation rate on VDZ drug retention rates | at week 54 and 108 | Analyze the difference in baseline erythrocyte sedimentation rate (mm/h) between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment). |
| Secondary | Analyze the impact of baseline 25(OH) D in peripheral blood on VDZ drug retention rates | at week 54 and 108 | Analyze the difference in baseline 25(OH) D in peripheral blood (ng/mL) between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment). |
| Secondary | Analyze the impact of baseline serum albumin in peripheral blood on VDZ drug retention rates | at week 54 and 108 | Analyze the difference in baseline serum albumin (g/L) in peripheral blood between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment). |
| Secondary | Analysis of the impact of baseline absolute eosinophil count in peripheral blood on VDZ drug retention rates | at week 54 and 108 | Analyze the difference in baseline absolute eosinophil count in peripheral blood (×10\^8) between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment). |
| Secondary | Analysis of the impact of baseline hemoglobin in peripheral blood on VDZ drug retention rates | at week 54 and 108 | Analyze the difference in baseline hemoglobin in peripheral blood (g/L) between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment). |
| Secondary | Analysis of the impact of baseline white blood cell count in peripheral blood on VDZ drug retention rates | at week 54 and 108 | Analyze the difference in baseline white blood cell count in peripheral blood (×10\^9) between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment). |
| Secondary | Analysis of the impact of baseline platelet count in peripheral blood on VDZ drug retention rates | at week 54 and 108 | Analyze the difference in baseline platelet count in peripheral blood (×10\^9) between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment). |
| Secondary | Analysis of the impact of baseline body mass index on VDZ drug retention rates | at week 54 and 108 | Analyze the difference in baseline body mass index between VDZ-continued group and VDZ-discontinued group (Baseline is defined as week 0 of VDZ treatment). Body Mass Index (BMI) is a numerical value derived from an individual's weight and height, calculated by dividing the weight in kilograms by the square of the height in meters (kg/m²). Baseline height (m) and weight (kg) of patients need be collected. |
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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