Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649136
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
MethMax Trial MAXimising the METHotrexate Therapy Potential in Patients with Active Rheumatoid Arthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An International Multicentre Interventional Randomised Assessor-blinded Trial to MAXimise the METHotrexate Therapy Potential in Patients with Active Rheumatoid Arthritis
Status:
RECRUITING
Status Verified Date:
2024-10
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:
MethMax
Brief Summary:
The MethMax trial is a prospective international multicentre randomised assessor-blinded parallel-group low intervention study Patients with active rheumatoid arthritis treated with oral methotrexate up to 25mg weekly will be randomised in 5050 fashion to receive 25mg oral vs subcutaneous methotrexate for the period of 24 weeks In regular visits patient reported outcomes clinical disease activity therapy adherence and diverse established and exploratory biomarkers will be assessed
Detailed Description:
Methotrexate is recommended as the first-line therapy in patients with rheumatoid arthritis However a significant proportion of patients does not achieve disease remission with methotrexate monotherapy which can be attributed to multiple reasons We hypothesize that the efficacy limitations of this well-known medication can be to some extent overcome by sufficient dose and route optimisation Furthermore individual factors effecting the treatment response are unknown Thus we aim to evaluate the maximised methotrexate therapy before switching to biologic or targeted synthetic drugs
The MethMax trial is a prospective randomised assessor-blinded parallel-group low-intervention trial including 182 patients across 7 European countries Patients with active rheumatoid arthritis naïve to biologic or targeted synthetic antirheumatic drugs who have been on a stable oral methotrexate therapy for the past 3 months will be randomised in 11 ratio to either 25mg oral or 25mg subcutaneous methotrexate weekly In both arms a short glucocorticoid therapy will be prescribed at baseline visit The active study duration for each patient is 24 weeks After inclusion study visits take place at baseline weeks 4 8 12 16 and 24 The clinical efficacy and safety parameters will be obtained at each visit At predefined timepoints further patient reported outcomes exploratory biomarkers like sweat and blood metabolites as well as medication adherence will be assessed Written consent will be obtained for all participants The study has received regulatory approval via the Clinical Trials Information System and has recently started recruitment at the first centre
The anticipated results will suggest whether the subcutaneous administration of 25mg methotrexate weekly is superior to oral methotrexate 25mg and lower doses in each route respectively The outcomes include clinical disease activity methotrexate metabolism analyses and medication adherence The gained knowledge could lead to individual therapy optimisation and new therapy recommendations
The MethMax trial is a prospective randomised assessor-blinded parallel-group low-intervention trial including 182 patients across 7 European countries Patients with active rheumatoid arthritis naïve to biologic or targeted synthetic antirheumatic drugs who have been on a stable oral methotrexate therapy for the past 3 months will be randomised in 11 ratio to either 25mg oral or 25mg subcutaneous methotrexate weekly In both arms a short glucocorticoid therapy will be prescribed at baseline visit The active study duration for each patient is 24 weeks After inclusion study visits take place at baseline weeks 4 8 12 16 and 24 The clinical efficacy and safety parameters will be obtained at each visit At predefined timepoints further patient reported outcomes exploratory biomarkers like sweat and blood metabolites as well as medication adherence will be assessed Written consent will be obtained for all participants The study has received regulatory approval via the Clinical Trials Information System and has recently started recruitment at the first centre
The anticipated results will suggest whether the subcutaneous administration of 25mg methotrexate weekly is superior to oral methotrexate 25mg and lower doses in each route respectively The outcomes include clinical disease activity methotrexate metabolism analyses and medication adherence The gained knowledge could lead to individual therapy optimisation and new therapy recommendations
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