Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043732
Status:
COMPLETED
Last Update Posted:
2010-04-27
First Post:
2002-08-12
Brief Title:
Safety Study of SCIO-469 to Treat Patients With Active Rheumatoid Arthritis Receiving Methotrexate
Sponsor:
Scios Inc
Organization:
Scios Inc
Study Overview
Official Title:
A Phase II Multicenter Randomized Double-Blind Placebo-Controlled Dose-Escalating Study of SCIO-469 in Patients in Active Rheumatoid Arthritis Receiving Methotrexate
Status:
COMPLETED
Status Verified Date:
2010-04
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:
The main objective of the study is to evaluate the safety and tolerability of six escalating doses of SCIO-469 in RA patients SCIO-469 belongs to a new class of treatments that inhibit p38 kinase a stimulatory modulator of pro-inflammatory factors including tumor necrosis factor-alpha TNF-alpha interleukin-1 IL-1 and cyclooxygenase-2 COX-2 all of which are known to contribute to both symptoms and disease progression in patients with Rheumatoid Arthritis
Detailed Description:
This multicenter randomized double-blind placebo-controlled dose-escalating study will assess the safety tolerability efficacy PK and pharmacodynamics of SCIO-469 in patients with active RA who also are receiving methotrexate A total of 120 subjects will be randomly assigned and treated in one of seven dose groups with the total daily dose of SCIO-469 ranging from 0 to 180 mg Dose groups will be staggered over four Treatment Periods Safety and available PK data from a Treatment Period with lower dose groups will be reviewed prior to initiating higher dose groups in the next Treatment Period Placebo subjects will be randomized in all Treatment Periods Study drug will be taken for 30 days Each subject will be followed for approximately 4 weeks after completing the 30-day Treatment Period Safety will be assessed by way of physical examination medical history vital signs orthostatic vital signs chest radiograph 12-lead electrocardiogram ECG clinical laboratory evaluations including serum chemistry hematology qualitative urinalysis and liver function tests purified protein derivative test for tuberculosis neurological tests adverse events and concomitant medications through out the study Study drug will be administered for 30 days at one of the following dosage strengths 30 mg 60 mg 90 mg One group of subjects will get 60 mg for one week followed by 120 for one week followed by 180 mg for two 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