Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223301
Status:
COMPLETED
Last Update Posted:
2013-04-22
First Post:
2005-09-19
Brief Title:
Safety Study of Combination Therapy With Intramuscular Avonex and Oral Cellcept in Patients With Multiple Sclerosis
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
A One-Year Prospective Randomized Placebo-Controlled Double-Blind Phase IIIII Safety Trial of Combination Therapy With IFN Beta-1a Avonex and Mycophenolate Mofetil Cellcept in Early Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2013-04
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:
1 To determine the safety and tolerability of oral Cellcept when used in combination with weekly intramuscular Avonex in early MS
2 To document changes in exacerbation frequency
3 To document the incidence of mild moderate and severe exacerbations in the treated groups categorical analysis
4 To document changes in the level of sustained disability as measured by the expanded disability status score EDSS and ambulation index AI
5 To document changes in quality of life measures
6 To assess fatigue with the validated fatigue assessment inventory
7 Neuroimmunological studiesAt baseline 6 and 12 months after treatment
2 To document changes in exacerbation frequency
3 To document the incidence of mild moderate and severe exacerbations in the treated groups categorical analysis
4 To document changes in the level of sustained disability as measured by the expanded disability status score EDSS and ambulation index AI
5 To document changes in quality of life measures
6 To assess fatigue with the validated fatigue assessment inventory
7 Neuroimmunological studiesAt baseline 6 and 12 months after treatment
Detailed Description:
Design Uni-center double-blind randomized placebo-controlled study of Avonex placebo vs Avonex Cellcept
Rationale A number of immunopathogenic mechanisms have been hypothesized to figure prominently in the processes that culminate in the characteristic plaque lesion These include the role of cytokines chemokines excitatory amino acids free radicals superoxides and nitric oxide synthetase products Recognizing that the disease process in MS involves a cascade of biological events sets the stage for strategically targeting specific immunopathogenetic steps through rational combination therapy regimens We now propose a combination clinical trial utilizing Avonex and mycophenolate mofetil MMF a novel agent with a broad spectrum of anti- inflammatory mechanisms
Study population MS patients who have been diagnosed with clinically definite laboratory supported definite or monosymptomatic MS meeting CHAMPS criteria ref of either sex who are between the ages of 21 and 50 inclusive
Treatment Groups 12 patients in each group ALL patients on Intramuscular Avonex CellceptPlacebo will be started at 250mg bid for one week and then escalated by 250mg bid until a target dose of 1000mg bid is achieved and Avonex 30 mcg IM q week
Patients also see an examining physician every three months have brain MRI scans done every other month and donate WBCs through a procedure called leukapheresis done every six months
Efficacy ParametersEvaluations EDSS PSAT MSFC and MRI relapse rate and safety measures
Safety ParametersEvaluations Safety will be assessed by virtue of changes in T2FLAIR lesions number and volume and in gadolinium enhancements measured at 6 and 12 months after treatment initiation compared to baseline measurements derived from one pretreatment run- in scan In addition a variety of clinical assessments will be performed for the period of 12 months of treatment We will enroll 12 patients in each group 24 total
Rationale A number of immunopathogenic mechanisms have been hypothesized to figure prominently in the processes that culminate in the characteristic plaque lesion These include the role of cytokines chemokines excitatory amino acids free radicals superoxides and nitric oxide synthetase products Recognizing that the disease process in MS involves a cascade of biological events sets the stage for strategically targeting specific immunopathogenetic steps through rational combination therapy regimens We now propose a combination clinical trial utilizing Avonex and mycophenolate mofetil MMF a novel agent with a broad spectrum of anti- inflammatory mechanisms
Study population MS patients who have been diagnosed with clinically definite laboratory supported definite or monosymptomatic MS meeting CHAMPS criteria ref of either sex who are between the ages of 21 and 50 inclusive
Treatment Groups 12 patients in each group ALL patients on Intramuscular Avonex CellceptPlacebo will be started at 250mg bid for one week and then escalated by 250mg bid until a target dose of 1000mg bid is achieved and Avonex 30 mcg IM q week
Patients also see an examining physician every three months have brain MRI scans done every other month and donate WBCs through a procedure called leukapheresis done every six months
Efficacy ParametersEvaluations EDSS PSAT MSFC and MRI relapse rate and safety measures
Safety ParametersEvaluations Safety will be assessed by virtue of changes in T2FLAIR lesions number and volume and in gadolinium enhancements measured at 6 and 12 months after treatment initiation compared to baseline measurements derived from one pretreatment run- in scan In addition a variety of clinical assessments will be performed for the period of 12 months of treatment We will enroll 12 patients in each group 24 total
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