Ignite Creation Date:
2024-05-05 @ 11:11 PM
Last Modification Date:
2024-10-26 @ 10:29 AM
Study NCT ID:
NCT01270035
Status:
UNKNOWN
Last Update Posted:
2011-06-27
First Post:
2011-01-04
Brief Title:
Efficacy and Safety of Adalimumab 80 mg Every Other Week With Methotrexate
Sponsor:
Keio University
Organization:
Keio University
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2010-12
Last Known Status:
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:
In Japan as well as in other countries the dose of adalimumab ADA is limited to 40 mg every other week when used in combination with methotrexate MTX for patients with rheumatoid arthritis RA However ADA 80 mg with MTX may be required for some RA patients especially for those with high disease activity Therefore we tried to increase the ADA dose to 80 mg every other week with concomitant MTX only if the disease activity did not decrease below moderate activity defined by DAS28 32 The primary endpoint was the rate of patients who achieved disease remission DAS28 26 at 30 weeks with this predifined treatment strategy
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