Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584162
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-06-22
Brief Title:
Subcutaneous Interval Lengthening of Vedolizumab for Economic Research
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Subcutaneous Vedolizumab Drug De-escalation Using Therapeutic Drug Monitoring in Inflammatory Bowel Disease a Randomized Controlled Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SILVER
Brief Summary:
Rationale Subcutaneous vedolizumab is an effective maintenance therapy for patients with inflammatory bowel disease Patients using subcutaneous vedolizumab every 2 weeks have higher vedolizumab serum trough concentrations than those who are treated with intravenous vedolizumab every 4-8 weeks Since biologic therapies such as vedolizumab are expensive lengthening of the injection interval de-escalation is of interest to reduce health care costs However maintaining remission while extending vedolizumab injection intervals has not been evaluated yet but represents a critical component of both medical and societal costs Studies have suggested that higher vedolizumab serum concentrations are associated with superior clinical outcomes Our strategy is to administer subcutaneous vedolizumab with prolonged intervals using therapeutic drug monitoring ie dose based on vedolizumab concentrations to reduce medical and societal costs while preserving remission
Objectives To evaluate whether subcutaneous vedolizumab therapeutic drug monitoring TDM-guided de-escalation will be cost-effective compared to normal dosing regimen in patients with inflammatory bowel disease in remission The secondary objective is to investigate the efficacy of TDM-guided de-escalation subcutaneous vedolizumab dosing compared to standard dosing
Study design This is a single-centre randomized controlled open-label pilot study
Study population 40 patients with inflammatory bowel disease Crohns disease or ulcerative colitis in steroid-free clinical and biochemical remission with subcutaneous vedolizumab maintenance therapy of 108 mg every other week for at least 6 months
Intervention Patients will be randomized 11 to the TDM-guided subcutaneous vedolizumab de-escalation strategy versus standard care eg continuing standard subcutaneous vedolizumab dosing regimen of 108 mg every other week
Main study parametersendpoints Primary endpoint cost-effectiveness of the TDM-guided de-escalation group compared to the standard dosing group over 48 weeks Secondary endpoints include proportion of patients with sustained clinical remission based on Harvey-Bradshaw Index or Simple Clinical Colitis Activity Index proportion of patients with sustained biochemical remission based on c-reactive protein and fecal calprotectin pharmacokinetic differences vedolizumab levels and immunogenicity safety and quality of life measured by SIBDQ and EQ-5D-5L
Objectives To evaluate whether subcutaneous vedolizumab therapeutic drug monitoring TDM-guided de-escalation will be cost-effective compared to normal dosing regimen in patients with inflammatory bowel disease in remission The secondary objective is to investigate the efficacy of TDM-guided de-escalation subcutaneous vedolizumab dosing compared to standard dosing
Study design This is a single-centre randomized controlled open-label pilot study
Study population 40 patients with inflammatory bowel disease Crohns disease or ulcerative colitis in steroid-free clinical and biochemical remission with subcutaneous vedolizumab maintenance therapy of 108 mg every other week for at least 6 months
Intervention Patients will be randomized 11 to the TDM-guided subcutaneous vedolizumab de-escalation strategy versus standard care eg continuing standard subcutaneous vedolizumab dosing regimen of 108 mg every other week
Main study parametersendpoints Primary endpoint cost-effectiveness of the TDM-guided de-escalation group compared to the standard dosing group over 48 weeks Secondary endpoints include proportion of patients with sustained clinical remission based on Harvey-Bradshaw Index or Simple Clinical Colitis Activity Index proportion of patients with sustained biochemical remission based on c-reactive protein and fecal calprotectin pharmacokinetic differences vedolizumab levels and immunogenicity safety and quality of life measured by SIBDQ and EQ-5D-5L
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None