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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Biogen Idec
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01930708
First received: August 15, 2013
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

The primary objective of the study is to estimate the annualized relapse rate (ARR) in subjects 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 patient-reported health-related quality of life (HRQoL) outcomes, additional clinical effectiveness outcomes, and health economics-related outcomes, and to characterize patient-reported adherence to DMF.


Condition Intervention Phase
Relapsing-Remitting Multiple Sclerosis
Multiple Sclerosis
Drug: dimethyl fumarate (DMF)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Annualized Relapse Rate (ARR) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Multiple Sclerosis Impact Scale (MSIS-29) score [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Change from Baseline in Modified Fatigue Impact Scale-5 Item (MFIS-5) score [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Change from Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) score [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Change from Baseline in EQ-5D 5 level version (EQ-5D-5L) index [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Change from Baseline in Patient-Reported Indices for Multiple Sclerosis-Activity Limitations (PRIMUS-Activity Limitations) score [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Change from Baseline in Work Productivity and Activity Impairment-Multiple Sclerosis version (WPAI-MS) score [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Change from Baseline in Beck Depression Inventory-Fast Screen (BDI-Fast Screen) score [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Proportion of subjects with confirmed (24-week) Expanded Disability Status Scale (EDSS) progression [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Annualized Relapse Rate (ARR) at Baseline (i.e., over the 12 months prior to enrollment) and at Month 6 [ Time Frame: Baseline, 6 Months ] [ Designated as safety issue: No ]
  • The proportion of subjects relapsed [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of subjects who report taking the prescribed DMF dose [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Percentage of subjects who report taking the prescribed DMF dose [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Reasons reported by subjects for not taking prescribed DMF dose [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Change from baseline in EQ Visual Analog Scale (EQVAS) score [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1080
Study Start Date: October 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DMF administered per the approved label
dimethyl fumarate (DMF) administered per the approved dosage in the country where DMF has received marketing authorization
Drug: dimethyl fumarate (DMF)
120 mg capsule oral twice daily (BID) during the first week of the treatment period
Other Names:
  • Tecfidera
  • DMF
  • BG00012
Drug: dimethyl fumarate (DMF)
240 mg capsule oral twice daily (BID) for the remainder of the treatment period
Other Names:
  • Tecfidera
  • BG00012
  • DMF

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01930708

Contacts
Contact: Biogen Idec Investigator clinicaltrials@biogenidec.com

  Show 58 Study Locations
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Medical Director Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01930708     History of Changes
Other Study ID Numbers: 109MS408, 2013-001656-35
Study First Received: August 15, 2013
Last Updated: August 29, 2014
Health Authority: Canada: Ethics Review Committee
Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Slovenia: Agency for Medicinal Products - Ministry of Health
Spain: Spanish Agency of Medicines
Austria: Agency for Health and Food Safety
Czech Republic: State Institute for Drug Control
Slovakia: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Canada: Health Canada
Portugal: National Authority of Medicines and Health Products, IP (INFARMED)
Italy: The Italian Medicines Agency

Keywords provided by Biogen Idec:
BG-12

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Dimethyl fumarate
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 30, 2014