Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089921
Status:
COMPLETED
Last Update Posted:
2010-10-18
First Post:
2004-08-17
Brief Title:
SPRiNG SCIO-469 Patients With Rheumatoid Arthritis Not Receiving Methotrexate
Sponsor:
Scios Inc
Organization:
Scios Inc
Study Overview
Official Title:
A 24-Week Randomized Double-Blind Placebo-Controlled Parallel Group Study of the Efficacy of Oral SCIO-469 in Subjects With Active Rheumatoid Arthritis Who Are Not Receiving DMARDs Other Than Hydroxychloroquine
Status:
COMPLETED
Status Verified Date:
2010-10
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:
The primary objective of this study is to determine the efficacy of oral SCIO-469 in patients with rheumatoid arthritis who are not receiving liver damaging hepatotoxic disease-modifying anti-rheumatic drugs DMARDs
Detailed Description:
This is a 24 week randomized study drug assigned by chance double blind neither physician nor patient knows the name of the assigned drug placebo controlled parallel group study assessing the safety and effectiveness of oral SCIO-469 in treating patients with rheumatoid arthritis who are not receiving liver damaging hepatotoxic disease-modifying anti-rheumatic drugs DMARDs The patient will participate in the study for approximately 183 days Safety measures will include vital signs blood pressure pulse rate breathing rate 12-lead electro-cardiogram adverse events concomitant medications and clinical laboratory evaluations including serum chemistry hematology qualitative urinalysis and liver function tests The patient may be assigned to receive 30 mg capsule orally by mouth as one or two capsules three times daily or receive 100 mg tablet orally once daily or placebo no active drug orally as two capsules three times daily and placebo tablet orally once daily for 24 weeks
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| B007 | None | None | None |
| SCIO-469ARA2003 | None | None | None |