Ignite Creation Date:
2024-05-05 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00551707
Status:
COMPLETED
Last Update Posted:
2014-04-29
First Post:
2007-10-29
Brief Title:
Multicenter Study to Evaluate CRx-102 vs Each of Its Components to Treat Active Rheumatoid Arthritis
Sponsor:
Zalicus
Organization:
Zalicus
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multi-Center Study to Evaluate the Superiority of CRx-102 Over Each of Its Components When Given to Subjects With Active Rheumatoid Arthritis RA
Status:
COMPLETED
Status Verified Date:
2014-03
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:
MARS-1
Brief Summary:
CRx-102 is a synergistic combination drug candidate containing the cardiovascular drug dipyridamole and a very low dose of the glucocorticoid prednisolone CRx-102 is believed to work through a novel mechanism of action in which dipyridamole selectively amplifies the anti-inflammatory and immunomodulatory activities of the glucocorticoid without replicating the dose-dependent adverse effects CRx-102 has been associated with clinical benefit in proof of concept studies in subjects with hand Osteoarthritis OA and Rheumatoid Arthritis RA
In this trial CRx-102 will be given to subjects with active RA as an add-on therapy to existing stable doses of Disease Modifying Anti-Rheumatic Drugs DMARDs including methotrexate MTX sulfasalazine hydroxychloroquine leflunomide or azathioprine MTX in combination with other DMARDs eg sulfasalazine or hydroxychloroquine will be permitted to reflect the current standard of care practices within rheumatology
In this trial CRx-102 will be given to subjects with active RA as an add-on therapy to existing stable doses of Disease Modifying Anti-Rheumatic Drugs DMARDs including methotrexate MTX sulfasalazine hydroxychloroquine leflunomide or azathioprine MTX in combination with other DMARDs eg sulfasalazine or hydroxychloroquine will be permitted to reflect the current standard of care practices within rheumatology
Detailed Description:
The study was discontinued before the enrollment objective was met Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP Therefore only the CRP values over time and the percent change in C-reactive protein CRP values in the As-Treated population were calculated
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