Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211887
Status:
COMPLETED
Last Update Posted:
2014-04-03
First Post:
2005-09-13
Brief Title:
Combination Therapy in Patients With Relapsing-Remitting Multiple Sclerosis MSCombiRx
Sponsor:
Fred Lublin
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
A Multi-Center Double-Blind Randomized Study Comparing the Combined Use of Interferon Beta-1a and Glatiramer Acetate to Either Agent Alone in Patients With Relapsing-Remitting Multiple Sclerosis CombiRx
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:
None
Brief Summary:
This is for a randomized clinical trial RCT to determine if the combined use of interferon beta-1a IFN and glatiramer acetate GA is a measurably better therapy than either agent used individually in patients with relapsing-remitting RR multiple sclerosis MS
Detailed Description:
This is a multicenter double blind randomized trial examining combination therapy versus single agent therapy with three-year follow-up on the last patient randomized All patients will remain on therapy until the last patient completes the study All patients will then be transitioned based on the findings to open label of combination with continued follow-up or some recommendation about single agent therapy While the study design benefits from having two arms of single agent therapy to examine the important question of whether there are differences between the single agents the primary interest is in combination therapy Therefore a two-group combination versus single agent concept was used - splitting the population into single agent and combination therapy equally The single agent arm is divided into two groups IFN and GA providing for 3 treatment arms IFN intramuscularly IM and GA subcutaneously SC 50 of the patients IFN IM and placebo SC 25 of the patients and GA SC and placebo IM 25 of the patients
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 |
|---|---|---|---|
| U01NS045719 | NIH | None | httpsreporternihgovquickSearchU01NS045719 |
| 02-0526 | None | None | None |
| CRC | None | None | None |