Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).

June 10, 2019 updated by: Biogen

An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis

The primary objective of the study is to evaluate the effect of BG00012 on lymphocyte subset counts during the first year of treatment in subjects with relapsing-remitting multiple sclerosis (RRMS). A secondary objective is to evaluate the pharmacodynamic effect on absolute lymphocyte counts (ALCs) and immunoglobulins (Igs) during the first year of treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
218

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brasschaat, Belgium, 2930
        • Research Site
    • Hainaut
      • La Louviere, Hainaut, Belgium, 7100
        • Research Site
    • West-Vlaanderen
      • Brugge, West-Vlaanderen, Belgium, 8000
        • Research Site
  • Bulgaria
      • Plaven, Bulgaria, 5800
        • Research Site
      • Pleven, Bulgaria, 5800
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Sofia, Bulgaria, 1606
        • Research Site
      • Sofia, Bulgaria, 1113
        • Research Site
  • Kuwait
      • Kuwait City, Kuwait, 00001
        • Research Site
  • Lithuania
      • Kaunas, Lithuania, LT-50009
        • Research Site
      • Klaipeda, Lithuania, 92288
        • Research Site
      • Vilnius, Lithuania, LT-08661
        • Research Site
  • Poland
      • Bydgoszcz, Poland, 85-795
        • Research Site
      • Katowice, Poland, 40-595
        • Research Site
      • Katowice, Poland, 40-650
        • Research Site
      • Lodz, Poland, 90-324
        • Research Site
      • Plewiska, Poland, 62-064
        • Research Site
      • Szczecin, Poland, 70-215
        • Research Site
  • Turkey
    • Kocaeli
      • Umuttepe, Kocaeli, Turkey, 41380
        • Research Site
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Research Site
    • California
      • Long Beach, California, United States, 90806
        • Research Site
    • Florida
      • Ocala, Florida, United States, 34471
        • Research Site
      • Oldsmar, Florida, United States, 34677
        • Research Site
      • Tampa, Florida, United States, 33612
        • Research Site
      • Tampa, Florida, United States, 33609
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Research Site
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 33612
        • Research Site
    • Michigan
      • Traverse City, Michigan, United States, 49684
        • Research Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Research Site
    • South Carolina
      • Spartanburg, South Carolina, United States, 29307
        • Research Site
    • Texas
      • San Antonio, Texas, United States, 78258
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States, 84103
        • Research Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Subjects of childbearing potential (including female subjects who are post-menopausal for less than 1 year) must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
  • Must have a confirmed diagnosis of RRMS according to the revised McDonald criteria (2010) [Polman 2011]

Key Exclusion Criteria:

  • History of or positive test result at Screening for:
  • human immunodeficiency virus
  • hepatitis C virus antibody
  • hepatitis B infection
  • Drug or alcohol abuse within 1 year prior to Screening.
  • Prior treatment with any of the following:
  • cladribine
  • mitoxantrone
  • total lymphoid irradiation
  • alemtuzumab
  • T-cell or T-cell receptor vaccination
  • any therapeutic monoclonal antibody, with the exception of natalizumab or daclizumab
  • Treatment with any of the following medications or procedures within 6 months prior to Baseline (Day 1):
  • DMF (given as Fumaderm®) or BG00012; enrollment will be limited to no more than 40 subjects (out of 200) with prior DMF exposure
  • cyclosporine
  • azathioprine
  • methotrexate
  • mycophenolate mofetil
  • intravenous (IV) Ig
  • plasmapheresis or cytapheresis

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: dimethyl fumarate
120 mg twice daily (BID) for the first 7 days and 240 mg BID thereafter
Drug: dimethyl fumarate
Initial oral dose for 7 days with maintenance dose thereafter
Other Names:
  • BG00012
  • DMF
  • Tecfidera

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Lymphocyte subsets include T cell, B cell and Natural killer (NK) cells.
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
T-cells subsets includes Activated CD4+ T-cell, Activated CD8+ T-cell, Activated CD8+ T-cell [CD38+], Activated Th (T helper) 1 phenotype, Activated Th17 phenotype, Activated Th2-enriched phenotype, Activated CD4+ T-cell [CD38+HLA-DR+], Activated CD4+ T-cell [HLA-DR+], Activated CD8+ T-cell [HLA-DR+], Central Memory (CM) CD4+ T-cell [CD45RA-CCR7+], CM CD4+ T-cell [CD45RA-CCR7+], CM CD8+ T-cell [CD45RA-CCR7+], Effector CD4+ T-cell [CD45RA+CCR7-], Effector CD8+ T-cell [CD45RA+CCR7-], Effector Memory (EM) CD4+ T-cell [CD45RA-CCR7-], EM CD8+ T-cell [CD45RA-CCR7-], Effector Regulatory T-cells, Effector CD4+ T-cell [CD45RA+CCR7-], Effector CD8+ T-cell [CD45RA+CCR7-], Naïve CD4+ T-cell [CD45RA+], Naïve CD8+ T-cell [CD45RA+], Naïve (N) CD8+ T-cell [CD45RA+], Naïve Regulatory T-cells, Terminal Effector Regulatory T-cells, Th1 phenotype, Th17 phenotype, Th2-enriched phenotype. Here, Change at week is represented as CW.
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
B-cell subsets include CD10+ Transitional B cells, CD138+ Plasma Cells, Ig (Immunoglobulin) D+ Memory B cells [non-class switched], IgD- Memory B cells [class switched], Naïve B cells, Plasma Cells [CD10-], Transitional B-cells and Plasmablasts. Here, Change at week is represented as CW.
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Myeloid and natural killer cell subsets include CD56Bright NK cells, CD56Dim NK cells, Classical Monocytes, Myeloid dendritic cells, Non-classical Monocytes, Plasmacytoid dendritic cells, Total dendritic cells and Total monocytes [CD14+].
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
T-cell cytokine subsets include IFN (interferon) g+ (% of CD4+ T cells), IFNg+ (% of CD8+ T cells), IFNg+ (% of memory CD4+ T cells), IFNg+ (% of memory CD8+ T cells), IL- (interleukin) 17A+/IFNg- (% of CD4+ T cells), IL-17A+/IFNg- (% of CD8+ T cells), IL-17A+/IFNg- (% of memory CD4+ T cells), IL-17A+/IFNg- (% of memory CD8+ T cells), IL-2+ (% of CD4+ T cells), IL-2+ (% of CD8+ T cells), IL-2+ (% of memory CD4+ T cells), IL-2+ (% of memory CD8+ T cells), IL-4+ (% of CD4+ T cells), IL-4+ (% of CD8+ T cells), IL-4+ (% of memory CD4+ T cells) and IL-4+ (% of memory CD8+ T cells). Here, Change at week is represented as CW.
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Very Late Antigen-4 (VLA-4/Lymphocyte Function-Associated Antigen-1 (LFA-1) Antigen
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
VLA-4/LFA-1 antigen subsets include CD11a+ (% of B cells), CD11a+ (% of T cells), CD11a+ (% of MNC), CD11a+ (% of dendritic cells [CD11c++]), CD11a+ (% of lymphocytes), CD11a+ (% of monocytes), CD11a+ (% of neutrophils), CD49d+ (% of B cells), CD49d+ (% of T cells), CD49d+ (% of MNC), CD49d+ (% of dendritic cells [CD11c++]), CD49d+ (% of lymphocytes), CD49d+ (% of monocytes) and CD49d+ (% of neutrophils).
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in Immunoglobulin G (IgG) up to 48 Weeks
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 11, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 24, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 23, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 27, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 109MS310
  • 2015-001973-42 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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