Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00326339
Status:
COMPLETED
Last Update Posted:
2009-04-20
First Post:
2006-05-12
Brief Title:
Treatment of Arthritis With Syk Kinase Inhibition TASKI-1
Sponsor:
Rigel Pharmaceuticals
Organization:
Rigel Pharmaceuticals
Study Overview
Official Title:
A Phase II Multicenter Randomized Double-Blind Placebo-Controlled Ascending Dose Dose Ranging Study to Evaluate Up to Three Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate
Status:
COMPLETED
Status Verified Date:
2008-03
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:
None
Brief Summary:
This is a Phase II multicenter randomized double-blind placebo-controlled ascending dose dose ranging study to evaluate up to three doses of R935788 50 mg bid 100 mg bid and 150 mg bid Approximately 180 patients who have had rheumatoid arthritis for a minimum of 12 months and who have been receiving a weekly methotrexate MTX dose for a minimum of 6 months will be enrolled into the study
Detailed Description:
The primary objective of this study is to assess the preliminary efficacy of up to three different dosage regimens of R788 as determined by ACR 20 responder rates at 12 weeks The secondary objectives of this study are to assess the safety of up to three different dosage regimens of R788 as determined by ACR 20 responder rates at 12 weeks and to assess the general clinical and laboratory safety evaluations throughout the study
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