Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00141934
Status:
COMPLETED
Last Update Posted:
2007-04-05
First Post:
2005-08-31
Brief Title:
A Multicentre Trial to Determine the Efficacy of AD 452 in RA Subjects
Sponsor:
Sosei
Organization:
Sosei
Study Overview
Official Title:
Phase II Randomised Double-Blind Multicentre Placebo-Controlled Dose-Ranging Parallel Group Study to Compare the Efficacy Safety and Tolerability of 3 Strengths of AD 452 in Adults With Active RA Who Are Currently Taking Methotrexate
Status:
COMPLETED
Status Verified Date:
2007-04
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:
None
Brief Summary:
AD 452 is a new drug which is being developed for use in adult patients with RA It is believed that AD 452 may modify the underlying disease of RA as well as improving RA symptoms and in order to establish its efficacy and safety AD 452 is being tested in a 3 month study Patients enrolled in this study will already be taking methotrexate for their RA and they will remain on methotrexate throughout the study An earlier clinical study in 98 subjects with RA on stable background therapy investigated the pharmacokinetics safety and tolerability of AD 452 taken for one month The drug was well tolerated and no significant drug related adverse events were reported
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