Ignite Creation Date:
2024-05-06 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03505008
Status:
UNKNOWN
Last Update Posted:
2021-09-01
First Post:
2018-04-16
Brief Title:
Evaluation of the Optimal MTX Dose as an Add-on Therapy to Adalimumab for RA Patients in Japan South Korea and Taiwan
Sponsor:
Keio University
Organization:
Keio University
Study Overview
Official Title:
MIRACLE Methotrexate Inadequate Response Patient With Rheumatoid Arthritis Treated by Adalimumab in Combination With Low-dose Methotrexate Study
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
None
Brief Summary:
This study will be conducted in Japan South Korea and Taiwan to evaluate the optimal dosage of methotrexate MTX as an add-on therapy to adalimumab ADA in participants with rheumatoid arthritis RA who have not achieved remission by MTX monotherapy
Detailed Description:
The erythrocyte MTX-polyglutamates MTX-PG concentration will be measured to evaluate its relationship to the efficacy and safety of MTX therapy
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?:
None
Is an FDA AA801 Violation?:
None