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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02525874
Date of registration: 10/07/2015
Prospective Registration: Yes
Primary sponsor: Biogen
Public title: Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).
Scientific title: An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis
Date of first enrolment: August 11, 2015
Target sample size: 218
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02525874
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Belgium Bulgaria Croatia Kuwait Lithuania Poland Turkey United States
Contacts
Name:     Medical Director
Address: 
Telephone:
Email:
Affiliation:  Biogen
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Intervention(s)
Drug: dimethyl fumarate
Primary Outcome(s)
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]
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]
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]
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]
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]
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]
Secondary Outcome(s)
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]
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]
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]
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]
Secondary ID(s)
109MS310
2015-001973-42
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 27/06/2019
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02525874
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