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A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes (PROTEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01930708
Recruitment Status : Active, not recruiting
First Posted : August 29, 2013
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date  ICMJE August 15, 2013
First Posted Date  ICMJE August 29, 2013
Last Update Posted Date June 21, 2019
Actual Study Start Date  ICMJE October 31, 2013
Actual Primary Completion Date March 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 26, 2013)
Annualized Relapse Rate (ARR) [ Time Frame: 12 Months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01930708 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2015)
  • Change from Baseline in Multiple Sclerosis Impact Scale (MSIS-29) score [ Time Frame: 12 Months ]
    This is a validated, 29-item, MS-specific HRQoL scale that measures the physical (20 items) and psychological (9 items) impact of MS on the participant's day-to-day life during the previous 2 weeks. For each item, the subject is asked to circle the number that best describes his or her situation. The numbers for each item range from 1 (not at all) to 5 (extremely).
  • Change from Baseline in Modified Fatigue Impact Scale-5 Item (MFIS-5) score [ Time Frame: 12 Months ]
    This scale consists of 5 statements that describe how fatigue may affect a person. For each statement, the participant is asked to circle the number that best indicates how often fatigue has affected him or her during the previous 4 weeks. The numbers for each question range from 0 (never) to 4 (almost always).
  • Change from Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) score [ Time Frame: 12 Months ]
    This is a validated, 14-item questionnaire that measures a participant's level of satisfaction/dissatisfaction with medication.
  • Change from Baseline in EQ-5D 5 level version (EQ-5D-5L) index [ Time Frame: 12 Months ]
    The widely validated EQ-5D includes 2 components, the EQ-5D descriptive system and the EQ VAS. The EQ-5D descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the subject is instructed to indicate whether he or she has "no problems" (level 1), "slight problems" (level 2), "moderate problems" (level 3), "severe problems (level 4), or "extreme problems/inability" (level 5) on that day. For the EQ VAS, the participant is instructed to mark an "x" on a vertical scale at the point that best describes his or her own health on that day, where 0 represents the "worst health" he or she can imagine and 100 the "best health" he or she can imagine.
  • Change from Baseline in participants-Reported Indices for Multiple Sclerosis-Activity Limitations (PRIMUS-Activity Limitations) score [ Time Frame: 12 Months ]
    This 15-item component of the PRIMUS assesses a participant's ability to carry out various activities of daily living during the previous week without the use of aids (e.g., cane, walker, or wheelchair) or assistance. For each item, the participant is asked whether he or she can perform the activity without difficulty or with difficulty, or is unable to perform the activity.
  • Change from Baseline in Work Productivity and Activity Impairment-Multiple Sclerosis version (WPAI-MS) score [ Time Frame: 12 Months ]
    This 6-item instrument assesses employment status, and, during the previous 7 days, hours of missed work due to MS or other reasons, hours worked (if employed), effect on productivity due to MS while working, and activity impairment attributable to health problems.
  • Change from Baseline in Beck Depression Inventory-Fast Screen (BDI-Fast Screen) score [ Time Frame: 12 Months ]
    This is a 7-item scale that evaluates depression in participants with medical illness during the prior 2 weeks. It has been validated in subjects with MS.
  • Proportion of participants with confirmed (24-week) Expanded Disability Status Scale (EDSS) progression [ Time Frame: 12 Months ]
    The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.
  • Annualized Relapse Rate (ARR) at Baseline (i.e., over the 12 months prior to enrollment) and at Month 6 [ Time Frame: Baseline, 6 Months ]
  • The proportion of participants relapsed [ Time Frame: 12 Months ]
  • Number of participants who are hospitalized/have emergency room visits due to MS relapses or have relapses requiring intravenous (IV) steroid treatment during the study, or who make visits to neurologists/other specialists due to MS [ Time Frame: 12 Months ]
  • Proportion of participants who are hospitalized/have emergency room visits due to MS relapses or have relapses requiring intravenous (IV) steroid treatment during the study, or who make visits to neurologists/other specialists due to MS [ Time Frame: 12 Months ]
  • Proportion of participants who report taking the prescribed DMF dose [ Time Frame: 12 Months ]
  • Percentage of participants who report taking the prescribed DMF dose [ Time Frame: 12 Months ]
  • Reasons reported by participants for not taking prescribed DMF dose [ Time Frame: 12 Months ]
  • Change from baseline in EQ Visual Analog Scale (EQVAS) score [ Time Frame: 12 Months ]
    A component of the EQ-5D, where participants are asked to rate their overall health-related quality of life on a standard vertical 20 cm visual analogue scale (similar to a thermometer) between 100 (best health imaginable) and 0 (worst health imaginable).
Original Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2013)
  • Change from Baseline in Multiple Sclerosis Impact Scale (MSIS-29) score [ Time Frame: 12 Months ]
  • Change from Baseline in Modified Fatigue Impact Scale-5 Item (MFIS-5) score [ Time Frame: 12 Months ]
  • Change from Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) score [ Time Frame: 12 Months ]
  • Change from Baseline in EQ-5D 5 level version (EQ-5D-5L) index [ Time Frame: 12 Months ]
  • Change from Baseline in Patient-Reported Indices for Multiple Sclerosis-Activity Limitations (PRIMUS-Activity Limitations) score [ Time Frame: 12 Months ]
  • Change from Baseline in Work Productivity and Activity Impairment-Multiple Sclerosis version (WPAI-MS) score [ Time Frame: 12 Months ]
  • Change from Baseline in Beck Depression Inventory-Fast Screen (BDI-Fast Screen) score [ Time Frame: 12 Months ]
  • Proportion of subjects with confirmed (24-week) Expanded Disability Status Scale (EDSS) progression [ Time Frame: 12 Months ]
  • Annualized Relapse Rate (ARR) at Baseline (i.e., over the 12 months prior to enrollment) and at Month 6 [ Time Frame: Baseline, 6 Months ]
  • The proportion of subjects relapsed [ Time Frame: 12 Months ]
  • Number of subjects who are hospitalized/have emergency room visits due to MS relapses or have relapses requiring intravenous (IV) steroid treatment during the study, or who make visits to neurologists/other specialists due to MS [ Time Frame: 12 Months ]
  • Proportion of subjects who are hospitalized/have emergency room visits due to MS relapses or have relapses requiring intravenous (IV) steroid treatment during the study, or who make visits to neurologists/other specialists due to MS [ Time Frame: 12 Months ]
  • Proportion of subjects who report taking the prescribed DMF dose [ Time Frame: 12 Months ]
  • Percentage of subjects who report taking the prescribed DMF dose [ Time Frame: 12 Months ]
  • Reasons reported by subjects for not taking prescribed DMF dose [ Time Frame: 12 Months ]
  • Change from baseline in EQ Visual Analog Scale (EQVAS) score [ Time Frame: 12 Months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes
Official Title  ICMJE A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera™ (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects With Relapsing-Remitting Multiple Sclerosis in the Real-World Setting
Brief Summary

The primary objective of the study is to estimate the annualized relapse rate (ARR) in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who are treated with dimethyl fumarate (DMF) over a 12-month period.

The secondary objectives of this study in this population are to assess the impact of DMF over a 12-month period on participants -reported health-related quality of life (HRQoL) outcomes, additional clinical effectiveness outcomes, and health economics-related outcomes, and to characterize participants-reported adherence to DMF.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Relapsing-Remitting Multiple Sclerosis
  • Multiple Sclerosis
Intervention  ICMJE Drug: dimethyl fumarate
Administered as per the approved dosage in all countries where DMF has received marketing authorization.
Other Names:
  • Tecfidera
  • DMF
  • BG00012
Study Arms  ICMJE Experimental: DMF
120 mg capsule oral twice daily (BID) during the first week and 240 mg BID thereafter.
Intervention: Drug: dimethyl fumarate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 12, 2015)
1114
Original Estimated Enrollment  ICMJE
 (submitted: August 26, 2013)
1080
Estimated Study Completion Date  ICMJE January 23, 2020
Actual Primary Completion Date March 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Have a diagnosis of Relapsing-Remitting Multiple Sclerosis (RRMS) and satisfy the approved therapeutic indication for DMF (per the local DMF product information).
  • Must be naïve to DMF, Fumaderm®, and other compounded fumarates, and to MS therapies that are primarily prescribed second-line (e.g., natalizumab, fingolimod) and to alemtuzumab.
  • Have a recent complete blood count (CBC) that does not preclude the subject's participation in the study, in the judgment of the Investigator.

Key Exclusion Criteria:

  • Are unwilling or unable to comply with study requirements, or are deemed unsuitable for study participation as determined by the Investigator.
  • Have major comorbid conditions that preclude participation in the study, as determined by the Investigator.
  • Are pregnant, unless DMF is clearly needed and the potential benefit of DMF to the subjects justifies the potential risk to the fetus, in the judgment of the Investigator (in all countries except Austria). In Austria, pregnant subjects are excluded from participation in the study.
  • Are women of childbearing potential and are not using appropriate contraception (per the local DMF product information) as determined by the Investigator.
  • Women who are breastfeeding may be excluded (per the local DMF product information) at the discretion of the Investigator.
  • Have previously received or are receiving treatment with MS therapies primarily used second-line (e.g., natalizumab, fingolimod) or alemtuzumab, or are currently receiving and planning to continue on other disease-modifying therapies for RRMS.
  • Are hypersensitive to the active ingredient in the DMF drug product (i.e., DMF) or to any of the excipients listed in the local DMF product information.
  • Current enrollment in any clinical trial except for the Biogen Idec DMF Pregnancy Exposure Registry or other studies that, according to the study Medical Director, do not conflict with this study (e.g., health economics studies or local registries).

Other protocol-defined inclusion/exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Canada,   Czechia,   France,   Hungary,   Italy,   Portugal,   Slovakia,   Slovenia,   Spain
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01930708
Other Study ID Numbers  ICMJE 109MS408
2013-001656-35 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP