Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00179478
Status:
COMPLETED
Last Update Posted:
2017-09-06
First Post:
2005-09-12
Brief Title:
Long Term Study of Avonex Therapy Following a First Attack of Multiple Sclerosis
Sponsor:
Beth Israel Deaconess Medical Center
Organization:
Beth Israel Deaconess Medical Center
Study Overview
Official Title:
Controlled High-risk Avonex Multiple Sclerosis Prevention Study in Ongoing Neurologic Surveillance CHAMPIONS10
Status:
COMPLETED
Status Verified Date:
2017-08
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:
CHAMPIONS10
Brief Summary:
The current study is a continuation of the 5 year extension study of the phase III CHAMPS study see reference This study was designed to determine if immediate initiation of therapy with Interferon Beta-1a AVONEX after a first attack of multiple sclerosis MS continues to delay the development of further attacks CDMS and the development of neurological disability over a 10 year period of observation The initial 5 year extension study called CHAMPIONS5 reported that immediate initiation of interferon Beta-1a AVONEX after a first attack of MS continued to delay the development of CDMS and lowered relapse rates compared to delayed initiation of disease modifying treatment usually with AVONEX either at the time of a second attack or at the end of the phase III study 24 months The study was extended to 10 years to determine if these effects are sustained and result in less long term permanent disability
Detailed Description:
The CHAMPS study determined that immediate initiation of interferon beta 1a therapy AVONEX immediately following a first clinical demyelinating event in high risk patients ie those with at least 2 asymptomatic white matter lesions on cranial MR imaging 3 mm in diameter or ovoid delayed the development of clinical definite Multiple Sclerosis CDMSas defined by a second clinically verifiable attack involving another part of the central nervous system over 2 years of observation and significantly decreased the development of new or enlarging white matter lesions on MRI over 18 months see reference The current study is a long term extension of a cohort of CHAMPS study site and participants The three main aims of the study are as follows
1 To determine the long term neurological outcome in patients treated with interferon beta 1a AVONEX from onset of a first clinical demyelinating event
2 To determine if immediate initiation of AVONEX therapy the CHAMPS Avonex treatment group confers long term benefits compared to delayed initiation of therapy the CHAMPS placebo group on the rate of development of CDMS annualized relapse rates the development of permanent disability and MR measures of disease activity and progression
3 To determine predictors of long term disease activity and disability in patients following a first clinical demyelinating event
1 To determine the long term neurological outcome in patients treated with interferon beta 1a AVONEX from onset of a first clinical demyelinating event
2 To determine if immediate initiation of AVONEX therapy the CHAMPS Avonex treatment group confers long term benefits compared to delayed initiation of therapy the CHAMPS placebo group on the rate of development of CDMS annualized relapse rates the development of permanent disability and MR measures of disease activity and progression
3 To determine predictors of long term disease activity and disability in patients following a first clinical demyelinating event
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 |
|---|---|---|---|
| C-850 Extension study | OTHER | Biogen Inc | None |