Trial Details
RecruitingBasic Information
| Clinical ID | c2252 |
|---|---|
| Identifier | NL-OMON51420 |
| Trial Title | Subcutaneous vedolizumab drug de-escalation using therapeutic drug monitoring in inflammatory bowel disease: a randomized controlled pilot study - SILVER-study |
| Trial URL | Visit Original Page |
Study Information
| Study Results | No results available |
|---|---|
| Conditions | Crohn's disease and ulcerative colitis inflammatory bowel diseases;10017969 |
| Interventions | Based on concentration measurements, the injection interval will be adjusted to every 2, 3 or 4 weeks. During screening, a serum concentration measurement will be performed in all patients, followed by a finger prick in patients in the intervention group after 8, 14, 24, 30 and 40 weeks. There are 3 moments in the study where the injection interval can be adjusted, and extra control moments to prevent the concentration from falling too far. |
Participant Information
| Sponsor | Amsterdam UMC |
|---|---|
| City | - |
| Country/Region | Netherlands |
Enrollment Criteria
| Sex Requirement | NOT SPECIFIED |
|---|---|
| Age Requirement | ADULT, ELDER, OLDER_ADULT |
Study Design
| Study Type | Interventional |
|---|---|
| Phase | Not Available |
Time Information
| Start Date | 2025-04-24 |
|---|---|
| Primary Completion Date | - |
| Completion Date | - |