Clinical trial NCT02525874: Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).
Official title: An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis
Keywords: Tecfidera
DMF
dimethyl fumarate
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2015-08-18
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T Cell, B Cell, Natural Killer Cell (TBNK)
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
measure: Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cells Subsets
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
measure: Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: B-Cell Subsets
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
measure: Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: Myeloid and Natural Killer (NK) Cells
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
measure: Change From Baseline in Lymphocyte Subsets Counts up to 48 Weeks: T-Cell Cytokines
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
measure: 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
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Secondary outcomes:
measure: Change From Baseline in Immunoglobulin A (IgA) up to 48 Weeks
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
measure: Change From Baseline in Immunoglobulin M (IgM) up to 48 Weeks
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
measure: Change From Baseline in Immunoglobulin G (IgG) up to 48 Weeks
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
measure: Change From Baseline in Immunoglobulin G (IgG) Subclasses up to 48 Weeks
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 24, Week 36 and Week 48
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Research Site
state: Arizona
city: Long Beach
country: United States
facility: Research Site
state: California
city: Ocala
country: United States
facility: Research Site
state: Florida
city: Oldsmar
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Overland Park
country: United States
facility: Research Site
state: Kansas
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Traverse City
country: United States
facility: Research Site
state: Michigan
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Spartanburg
country: United States
facility: Research Site
state: South Carolina
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: La Louviere
country: Belgium
facility: Research Site
state: Hainaut
city: Brugge
country: Belgium
facility: Research Site
state: West-Vlaanderen
city: Brasschaat
country: Belgium
facility: Research Site
city: Plaven
country: Bulgaria
facility: Research Site
city: Pleven
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Kuwait City
country: Kuwait
facility: Research Site
city: Kaunas
country: Lithuania
facility: Research Site
city: Klaipeda
country: Lithuania
facility: Research Site
city: Vilnius
country: Lithuania
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Plewiska
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Umuttepe
country: Turkey
facility: Research Site
state: Kocaeli
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: