Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398106
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-03
First Post:
2024-04-24
Brief Title:
Proactive TDM Versus Standard Use of Biologics in Psoriasis
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
Proactive Therapeutic Drug Monitoring Versus Routine Care With the Novel Biologics in Psoriasis a Pragmatic Multicentric Randomised Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HELIOS
Brief Summary:
Biologics are effective agents for the treatment of psoriasis The newest generation of biologics block interleukin 17 and 23 Physicians always prescribe these drugs in a fixed dose but this may lead to under- and overdosing in some patients Underdosing may lead to inadequate response or loss of response over time Overdosage on the other hand can lead to higher risk of side effects and higher costs for the healthcare system In daily clinical practice physicians often tackle this real-world issue by blind trial- and- error dose modifications or switching to another biologic In this study we want to rationalize these dose modifications and optimize dosing based on the drug concentrations measured in the blood of the patient ie therapeutic drug monitoring Depending on the drug concentration the interval between injections will be lengthened or shortened with the aim to reach the required drug concentration to reach the best clinical result The trial will be conducted in 14 Belgian hospitals where patients will be divided into 2 study groups a group that will be advised on the dosing scheme of their biologic based on the measured drug concentration and a group that continues dosing as in daily clinical practice We will monitor if the clinical response and quality of life remains stable With this study we will track drug concentrations as we believe that they can guide dosing of biologics and we hope to achieve better safety lower healthcare expenses and higher patients treatment satisfaction while striving for the best clinical response
Detailed Description:
Rationale
Biologics are effective agents for the treatment of psoriasis The newest generation of biologics block interleukin 17 and 23 Physicians always prescribe these drugs in a fixed dose but this may lead to under- and overdosing in some patients Underdosing may lead to inadequate response or loss of response over time Overdosage on the other hand can lead to higher risk of side effects and higher costs for the healthcare system In daily clinical practice physicians often tackle this real-world issue by blind trial- and- error dose modifications or switching to another biologic In this study we want to rationalize these dose modifications and optimize dosing based on the drug concentrations measured in the blood of the patient ie therapeutic drug monitoring
Objectives The primary goal is to assess if proactive TDM is non-inferior compared to standard of care with respect to sustained disease control defined as an absolute PASI 2 OR a delta PASI from baseline 50 during at least 80 of all 3-monthly study visits over a period of 18 months in patients with moderate to severe psoriasis treated with novel biologics secukinumab ixekizumab or guselkumab Secondary goals are
To compare proactive TDM to standard of care with respect to disease activity quality of life treatment satisfaction and costs of treatment cost-effectiveness To identify baseline predictors for sustained disease control To evaluate the cost-effectiveness of proactive TDM To evaluate the safety of proactive TDM
Study design A multicentre pragmatic randomised controlled non-inferiority trial
Study population
Patients with moderate-to-severe psoriasis treated with secukinumab or ixekizumab IL-17 inhibitors or guselkumab IL-23 inhibitor in daily clinical practice for at least 6 months on standard dosing maintenance phase A total of 210 patients will be randomized 11 to the intervention group TDM based dosing or continuation of usual care
Intervention Stepwise treatment modifications based on drug levels if the drug level is belowabove the target the dose of the biologic will be increaseddecreased by stepwise interval shorteninglengthening - first modified by 33 and then 50 increase or decrease If the target is still not reached at the next study visit the dosing interval will be shortened or prolonged with one additional week at each additional visit until the target is reached
In case the dosing regimen shifts from dose increase to dose decrease or vice versa the dosing interval will be shortened or prolonged with one additional week at each additional visit until the target is reached
Biologics are effective agents for the treatment of psoriasis The newest generation of biologics block interleukin 17 and 23 Physicians always prescribe these drugs in a fixed dose but this may lead to under- and overdosing in some patients Underdosing may lead to inadequate response or loss of response over time Overdosage on the other hand can lead to higher risk of side effects and higher costs for the healthcare system In daily clinical practice physicians often tackle this real-world issue by blind trial- and- error dose modifications or switching to another biologic In this study we want to rationalize these dose modifications and optimize dosing based on the drug concentrations measured in the blood of the patient ie therapeutic drug monitoring
Objectives The primary goal is to assess if proactive TDM is non-inferior compared to standard of care with respect to sustained disease control defined as an absolute PASI 2 OR a delta PASI from baseline 50 during at least 80 of all 3-monthly study visits over a period of 18 months in patients with moderate to severe psoriasis treated with novel biologics secukinumab ixekizumab or guselkumab Secondary goals are
To compare proactive TDM to standard of care with respect to disease activity quality of life treatment satisfaction and costs of treatment cost-effectiveness To identify baseline predictors for sustained disease control To evaluate the cost-effectiveness of proactive TDM To evaluate the safety of proactive TDM
Study design A multicentre pragmatic randomised controlled non-inferiority trial
Study population
Patients with moderate-to-severe psoriasis treated with secukinumab or ixekizumab IL-17 inhibitors or guselkumab IL-23 inhibitor in daily clinical practice for at least 6 months on standard dosing maintenance phase A total of 210 patients will be randomized 11 to the intervention group TDM based dosing or continuation of usual care
Intervention Stepwise treatment modifications based on drug levels if the drug level is belowabove the target the dose of the biologic will be increaseddecreased by stepwise interval shorteninglengthening - first modified by 33 and then 50 increase or decrease If the target is still not reached at the next study visit the dosing interval will be shortened or prolonged with one additional week at each additional visit until the target is reached
In case the dosing regimen shifts from dose increase to dose decrease or vice versa the dosing interval will be shortened or prolonged with one additional week at each additional visit until the target is reached
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-509637-39-00 | CTIS | None | None |
| KCE-22-1375 | OTHER_GRANT | KCE | None |