Ignite Creation Date:
2024-05-06 @ 3:56 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02419638
Status:
WITHDRAWN
Last Update Posted:
2016-02-29
First Post:
2015-04-14
Brief Title:
Comparison of Rebif Compared to Tecifdera on Six-month Outcomes in Patients With Relapsing-remitting MS
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
None
Status:
WITHDRAWN
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Collaborative decision between study PI and sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare two commonly used MS medications IFN β-1a subcutaneous three times per week Rebif and oral twice daily dimethyl fumarate Tecfidera on mean number of new or enlarging T2 lesions at 6 months in adults with relapsing-remitting multiple sclerosis who are prescribed these medications and receive a 6 month MRI scan as standard of care
Detailed Description:
Primary objective To compare two commonly used MS medications IFN β-1a subcutaneous three times per week Rebif and oral twice daily dimethyl fumarate Tecfidera on mean number of new or enlarging T2 lesions at 6 months in adults with relapsing-remitting multiple sclerosis who are prescribed these medications and receive a 6 month MRI scan as standard of care
Key secondary objective To compare Rebif vs Tecfidera in reducing the T2 lesion volume number of T1 black holes gadolinium-enhancing lesions brain parenchymal fraction brain white matter fraction and brain gray matter fraction on the 6 month MRI
Other secondary objectives
To compare the two treatments on the following clinical efficacy measures which are routinely obtained as part of our clinical practice Expanded disability status score EDSS ambulation index AI disease steps and number of relapses In addition we will obtain the MSFC-4 which in addition to the AI which is routinely done will include the symbol digit modalities test SDMT low contrast visual acuity and 9 hole peg test
To compare adherence to the two treatments using an adherence question
Tertiary objectives
To compare the two treatments on optical coherence tomography OCT and visual acuity measures
To compare the following patient reported outcomes MSQOL-54 MSQOL54 Modified MOS Social Support Survey MSSS Modified Fatigue Impact Scale MFIS Center for Epidemiological Studies Depression Scale CES-D
To compare cognitive function using the brief repeatable battery of neuropsychological tests in Multiple Sclerosis BRB which includes the following cognitive measures Symbol Digit Modalities Test SDMT Selective Reminding Test SRT 1036 Spatial Recall Test 1036 Controlled Oral Word Association Test COWAT
To compare the following Pharmacoeconomic outcomes Healthcare Utilization and Costs QUALY Unscheduled visits office ER hospital out-of-pocket expenses eg durable medical equipment copays Work Productivity and Activity Impairment WPAI Treatment satisfaction questionnaire Treatment Satisfaction for Medication Questionnaire TSQM
Design The study is a single center 6-month randomized parallel-group single blind study to compare two FDA approved treatments for MS Rebif and Tecfidera in adults with relapsing-remitting MS 120 subjects will be treated with each medication total 240 patients Randomization will ensure balanced patient groups and prevent bias Patients will be prescribed the medication by their treating physician who will follow the patient in a open fashion as part of standard of care for MS including obtaining MRI imaging at 6 months At 6 months patients will have a neurologic exam by an independent examining physician and administration of questionaires by study staff blinded to their treatment
Methods Relapsing-remitting patients beginning medication and deemed suitable for treatment with Rebif or Tecfidera as part of standard of care for MS will be explained the nature of the study after which informed consent will be obtained They will undergo a baseline visit and then randomized to one of the two treatments Blood samples for biomarker studies will be collected at the baseline visit and at 6 months MRI is obtained prior to therapy and at 6 months as part of standard of care Following the completion of the 6 month study period subjects are able to continue on either of the two treatments or switch to another agent according to their own preference and following discussions with their treating MS neurologist
Subjects who discontinue treatments prior to the 6 month period are free to begin another therapy Upon discontinuation of treatment subjects will complete the end of study EOS visit as soon as possible and will be followed for the duration of the 6-month treatment phase
Key secondary objective To compare Rebif vs Tecfidera in reducing the T2 lesion volume number of T1 black holes gadolinium-enhancing lesions brain parenchymal fraction brain white matter fraction and brain gray matter fraction on the 6 month MRI
Other secondary objectives
To compare the two treatments on the following clinical efficacy measures which are routinely obtained as part of our clinical practice Expanded disability status score EDSS ambulation index AI disease steps and number of relapses In addition we will obtain the MSFC-4 which in addition to the AI which is routinely done will include the symbol digit modalities test SDMT low contrast visual acuity and 9 hole peg test
To compare adherence to the two treatments using an adherence question
Tertiary objectives
To compare the two treatments on optical coherence tomography OCT and visual acuity measures
To compare the following patient reported outcomes MSQOL-54 MSQOL54 Modified MOS Social Support Survey MSSS Modified Fatigue Impact Scale MFIS Center for Epidemiological Studies Depression Scale CES-D
To compare cognitive function using the brief repeatable battery of neuropsychological tests in Multiple Sclerosis BRB which includes the following cognitive measures Symbol Digit Modalities Test SDMT Selective Reminding Test SRT 1036 Spatial Recall Test 1036 Controlled Oral Word Association Test COWAT
To compare the following Pharmacoeconomic outcomes Healthcare Utilization and Costs QUALY Unscheduled visits office ER hospital out-of-pocket expenses eg durable medical equipment copays Work Productivity and Activity Impairment WPAI Treatment satisfaction questionnaire Treatment Satisfaction for Medication Questionnaire TSQM
Design The study is a single center 6-month randomized parallel-group single blind study to compare two FDA approved treatments for MS Rebif and Tecfidera in adults with relapsing-remitting MS 120 subjects will be treated with each medication total 240 patients Randomization will ensure balanced patient groups and prevent bias Patients will be prescribed the medication by their treating physician who will follow the patient in a open fashion as part of standard of care for MS including obtaining MRI imaging at 6 months At 6 months patients will have a neurologic exam by an independent examining physician and administration of questionaires by study staff blinded to their treatment
Methods Relapsing-remitting patients beginning medication and deemed suitable for treatment with Rebif or Tecfidera as part of standard of care for MS will be explained the nature of the study after which informed consent will be obtained They will undergo a baseline visit and then randomized to one of the two treatments Blood samples for biomarker studies will be collected at the baseline visit and at 6 months MRI is obtained prior to therapy and at 6 months as part of standard of care Following the completion of the 6 month study period subjects are able to continue on either of the two treatments or switch to another agent according to their own preference and following discussions with their treating MS neurologist
Subjects who discontinue treatments prior to the 6 month period are free to begin another therapy Upon discontinuation of treatment subjects will complete the end of study EOS visit as soon as possible and will be followed for the duration of the 6-month treatment phase
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