Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06440629
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-23
Brief Title:
Effect of Proactive Therapeutic Drug Monitoring on Maintenance of Sustained Disease Control in Adults With Rheumatoid Arthritis on a Subcutaneous TNF Inhibitor The Rheumatoid Arthritis Therapeutic DRUg Monitoring Trial RA-DRUM
Sponsor:
Diakonhjemmet Hospital
Organization:
Diakonhjemmet Hospital
Study Overview
Official Title:
A Multi-center Open Randomized 18-month Parallel-group Superiority Study to Compare the Effect of Proactive Therapeutic Drug Monitoring Versus Standard of Care With Regards to Maintenance of Sustained Disease Control Without Flare in Adults With Rheumatoid Arthritis Treated With a Subcutaneous Tumor Necrosis Factor Inhibitor
Status:
RECRUITING
Status Verified Date:
2024-10
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:
RA-DRUM
Brief Summary:
The goal of this clinical trial is to compare therapeutic drug monitoring TDM versus Standard of care in patients with rheumatoid arthritis treated with a subcutaneous tumor necrosis factor inhibitor adalimumab
The main question it aims to answer is
Is TDM superior to standard of care in order to maintain sustained disease control without flares
Participants will be followed with blood sampling every second month measuring serum drug levels and anti-drug antibodies of the TNFi In the TDM-group the researchers will adjust the dosage of the TNFi based on knowledge on optimal therapeutic ranges In the Standard of care group the TNFi will be administered according to standard of care without knowledge of serum drug levels or anti-drug antibodies
The main question it aims to answer is
Is TDM superior to standard of care in order to maintain sustained disease control without flares
Participants will be followed with blood sampling every second month measuring serum drug levels and anti-drug antibodies of the TNFi In the TDM-group the researchers will adjust the dosage of the TNFi based on knowledge on optimal therapeutic ranges In the Standard of care group the TNFi will be administered according to standard of care without knowledge of serum drug levels or anti-drug antibodies
Detailed Description:
There is a considerable variation in serum drug levels among rheumatoid arthritis RA patients on tumor necrosis factor inhibitors TNFi and a high number develop neutralizing anti-drug antibodies ADAb Sub-therapeutic drug levels and ADAb formation are major contributors to TNFi treatment failure and disease flare Proactive therapeutic drug monitoring TDM ie individualized drug dosing based on regular assessments of serum drug levels and ADAb has the potential to optimize the efficacy and safety of TNFi treatment
The aim of the RA-DRUM trial is to assess whether TDM is superior to standard of care in order to maintain sustained disease control without flares in patients with RA treated with the SC TNFi adalimumab
Participants will be randomized to
Administration of TNFi based on proactive TDM TDM group
Administration of TNFi based on standard of care without knowledge of serum drug levels or ADAb status Standard of care group
Participants will be followed for 18 months with on-site visits at baseline 4 8 12 and 18 months and digital visits at 2 6 10 14 and 16 months Blood sampling for serum drug levels and anti-drug antibodies will be done at all visits
The aim of the RA-DRUM trial is to assess whether TDM is superior to standard of care in order to maintain sustained disease control without flares in patients with RA treated with the SC TNFi adalimumab
Participants will be randomized to
Administration of TNFi based on proactive TDM TDM group
Administration of TNFi based on standard of care without knowledge of serum drug levels or ADAb status Standard of care group
Participants will be followed for 18 months with on-site visits at baseline 4 8 12 and 18 months and digital visits at 2 6 10 14 and 16 months Blood sampling for serum drug levels and anti-drug antibodies will be done at all visits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None