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Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With BG00012 (StarTec)

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
dimethyl fumarate
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting focused on measuring Cognition, Tecfidera, RRMS, BG00012

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Must have a confirmed diagnosis of RRMS according to McDonald criteria (Polman, Reingold et al. 2005).
  • Must have a baseline EDSS between 0.0 and 5.0, inclusive.
  • Must have experienced at least 1 relapse within the 12 months prior to randomization, with a prior brain MRI demonstrating lesion(s) consistent with MS, or show evidence of gadolinium-enhancing lesion(s) of the brain on an MRI performed within the 6 weeks prior to randomization.

Key Exclusion Criteria:

Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of screening:

  • Primary progressive, secondary progressive, or progressive relapsing MS, as defined by Lublin and Reingold (Lublin and Reingold 1996)
  • Severe depression (MADRS score >34) (Montgomery and Asberg 1979)
  • History of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment)
  • An MS relapse that has occurred within the 30 days prior to inclusion AND/OR the participant has not stabilized from a previous relapse prior to inclusion.

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BG00012

Arm Description

BG00012 administered orally at 120 mg twice daily (BID) for the first 7 days and 240 mg BID thereafter.

Outcomes

Primary Outcome Measures

Proportion of patients with worsening in cognitive improvement over 2 years.
As measured by at least 2 standard deviation (SD) below Italian normative data of the Rao's Brief Repeatable Battery of Neuropsychological Tests (BRB) and a 100-item version of the Stroop Test. The Brief Repeatable Battery of Neuropsychological Tests (BRB-N) is a sensitive measure of cognitive impairment in multiple sclerosis (MS) patients. The Stroop Test is a test used to measure a person's sustained attention for word reading and color naming with and without interference.

Secondary Outcome Measures

Change in cognitive impairment index score (CII) over two years
An individual cognitive change index will be measured by calculating changes on the cognitive impairment index (CII) for each participant between year 0 and year 1, and year 0 and year 2. The CII is an individual cognitive change index aimed at providing a more precise assessment of the amount and direction of cognitive changes over time.
Annualized relapse rate at year 1.
Annualized relapse rate at year 2.
Time to relapse over 2 years.
Proportion of patients with 6-month sustained progression of disability as measured by at least a 1.0 point increase from a baseline EDSS>1.0 or at least a 1.5 point increase from a baseline EDSS=0).
The Kurtzke Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis. The EDSS quantifies disability in eight Functional Systems (FS) and allows neurologists to assign a Functional System Score (FSS) in each of these. Each functional system is scored on a scale of 0 (no disability) to 5 or 6 (more severe disability). EDSS steps 1.0 to 4.5 refer to people with MS who are fully ambulatory. EDSS steps 5.0 to 9.5 are defined by the impairment to ambulation.
Assessment of baseline demographic, disease characteristics and related patient reported outcomes that predict CI at two years.
Demographics may include age and gender, disease characteristics may include year of diagnosis and disability and PRO may include fatigue and depression at the time of initiation of BG00012.
Change from baseline in a self rating version of the Montgomery and Asberg Depression Rating Scale (MADRS)
The MADRS instrument has nine questions, with an overall score ranging from 0 to 27 points
Change from baseline in fatigue as measured by the Modified Fatigue Impact Scale (MFIS)
The MFIS is a modified form of the Fatigue Impact Scale based on items derived from interviews with MS patients concerning how fatigue impacts their lives. This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The full-length MFIS consists of 21 items
Change from baseline in Quality of life (QOL) as measured by the EQ-5D Health Survey
The EQ-5D is a widely-used survey instrument for measuring economic preferences for health states. It is a self-administered questionnaire consisting of 5 sets of 3 questions pertaining to specific health states (i.e., mobility, self-care, pain, usual activities, anxiety).
Change from baseline in the Environmental Status Scale (ESS)
The Environmental Status Scale (ESS) is used to quickly evaluate a patient for handicap. It was derived from a measure of socio-economic status. It consists of seven parameters: (1) actual work status, (2) financial and economic status, (3) personal residence or home, (4) personal assistance required, (5) transportation, (6) community services, (7) social activity. Each parameter has a single score from minimum 0 to maximum 5. ESS score is the sum of the points for all 7 parameters: minimum score: 0; maximum score: 35. The higher the score the greater the handicap.

Full Information

First Posted
October 16, 2015
Last Updated
April 26, 2017
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT02579681
Brief Title
Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With BG00012
Acronym
StarTec
Official Title
Single Country Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis Patients Treated With BG00012
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 30, 2014 (Actual)
Primary Completion Date
December 21, 2016 (Actual)
Study Completion Date
December 21, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective(s) of the study are to assess the BG00012 (dimethyl fumarate) treatment effect on cognition over 2 year period in RRMS patients. The secondary objectives of this study are to further assess BG00012 treatment effect on cognition, predictors of cognitive impairment, clinical efficacy, and patient reported outcomes (PRO): depression, fatigue, quality of life, and work and social life activity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting
Keywords
Cognition, Tecfidera, RRMS, BG00012

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BG00012
Arm Type
Experimental
Arm Description
BG00012 administered orally at 120 mg twice daily (BID) for the first 7 days and 240 mg BID thereafter.
Intervention Type
Drug
Intervention Name(s)
dimethyl fumarate
Other Intervention Name(s)
Tecfidera, DMF, BG00012
Intervention Description
dimethyl fumarate administered as per the arm description
Primary Outcome Measure Information:
Title
Proportion of patients with worsening in cognitive improvement over 2 years.
Description
As measured by at least 2 standard deviation (SD) below Italian normative data of the Rao's Brief Repeatable Battery of Neuropsychological Tests (BRB) and a 100-item version of the Stroop Test. The Brief Repeatable Battery of Neuropsychological Tests (BRB-N) is a sensitive measure of cognitive impairment in multiple sclerosis (MS) patients. The Stroop Test is a test used to measure a person's sustained attention for word reading and color naming with and without interference.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Change in cognitive impairment index score (CII) over two years
Description
An individual cognitive change index will be measured by calculating changes on the cognitive impairment index (CII) for each participant between year 0 and year 1, and year 0 and year 2. The CII is an individual cognitive change index aimed at providing a more precise assessment of the amount and direction of cognitive changes over time.
Time Frame
Up to 2 years
Title
Annualized relapse rate at year 1.
Time Frame
Up to one year
Title
Annualized relapse rate at year 2.
Time Frame
Up to 2 years
Title
Time to relapse over 2 years.
Time Frame
2 years
Title
Proportion of patients with 6-month sustained progression of disability as measured by at least a 1.0 point increase from a baseline EDSS>1.0 or at least a 1.5 point increase from a baseline EDSS=0).
Description
The Kurtzke Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis. The EDSS quantifies disability in eight Functional Systems (FS) and allows neurologists to assign a Functional System Score (FSS) in each of these. Each functional system is scored on a scale of 0 (no disability) to 5 or 6 (more severe disability). EDSS steps 1.0 to 4.5 refer to people with MS who are fully ambulatory. EDSS steps 5.0 to 9.5 are defined by the impairment to ambulation.
Time Frame
Up to 2 years
Title
Assessment of baseline demographic, disease characteristics and related patient reported outcomes that predict CI at two years.
Description
Demographics may include age and gender, disease characteristics may include year of diagnosis and disability and PRO may include fatigue and depression at the time of initiation of BG00012.
Time Frame
Up to 2 years
Title
Change from baseline in a self rating version of the Montgomery and Asberg Depression Rating Scale (MADRS)
Description
The MADRS instrument has nine questions, with an overall score ranging from 0 to 27 points
Time Frame
2 years
Title
Change from baseline in fatigue as measured by the Modified Fatigue Impact Scale (MFIS)
Description
The MFIS is a modified form of the Fatigue Impact Scale based on items derived from interviews with MS patients concerning how fatigue impacts their lives. This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The full-length MFIS consists of 21 items
Time Frame
2 years
Title
Change from baseline in Quality of life (QOL) as measured by the EQ-5D Health Survey
Description
The EQ-5D is a widely-used survey instrument for measuring economic preferences for health states. It is a self-administered questionnaire consisting of 5 sets of 3 questions pertaining to specific health states (i.e., mobility, self-care, pain, usual activities, anxiety).
Time Frame
2 years
Title
Change from baseline in the Environmental Status Scale (ESS)
Description
The Environmental Status Scale (ESS) is used to quickly evaluate a patient for handicap. It was derived from a measure of socio-economic status. It consists of seven parameters: (1) actual work status, (2) financial and economic status, (3) personal residence or home, (4) personal assistance required, (5) transportation, (6) community services, (7) social activity. Each parameter has a single score from minimum 0 to maximum 5. ESS score is the sum of the points for all 7 parameters: minimum score: 0; maximum score: 35. The higher the score the greater the handicap.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Must have a confirmed diagnosis of RRMS according to McDonald criteria (Polman, Reingold et al. 2005). Must have a baseline EDSS between 0.0 and 5.0, inclusive. Must have experienced at least 1 relapse within the 12 months prior to randomization, with a prior brain MRI demonstrating lesion(s) consistent with MS, or show evidence of gadolinium-enhancing lesion(s) of the brain on an MRI performed within the 6 weeks prior to randomization. Key Exclusion Criteria: Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of screening: Primary progressive, secondary progressive, or progressive relapsing MS, as defined by Lublin and Reingold (Lublin and Reingold 1996) Severe depression (MADRS score >34) (Montgomery and Asberg 1979) History of malignancy (except basal cell carcinoma that has been completely excised prior to study enrollment) An MS relapse that has occurred within the 30 days prior to inclusion AND/OR the participant has not stabilized from a previous relapse prior to inclusion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Research site
City
Bari
Country
Italy
Facility Name
Research site
City
Cagliari
Country
Italy
Facility Name
Research site
City
Catania
Country
Italy
Facility Name
Research site
City
Cefalu
Country
Italy
Facility Name
Research site
City
Chieti
Country
Italy
Facility Name
Research site
City
Ferrara
Country
Italy
Facility Name
Research site
City
Fidenza
Country
Italy
Facility Name
Research site
City
Firenze
Country
Italy
Facility Name
Research site
City
Gallarate
Country
Italy
Facility Name
Research site
City
Genova
Country
Italy
Facility Name
Research site
City
L'aquila
Country
Italy
Facility Name
Research site
City
Milano
Country
Italy
Facility Name
Research site
City
Napoli
Country
Italy
Facility Name
Research site
City
Orbassano
Country
Italy
Facility Name
Research site
City
Padova
Country
Italy
Facility Name
Research site
City
Palermo
Country
Italy
Facility Name
Research site
City
Pavia
Country
Italy
Facility Name
Research site
City
Roma
Country
Italy

12. IPD Sharing Statement

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Study Assessing Cognition in Relapsing Remitting Multiple Sclerosis (RRMS) Patients Treated With BG00012

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