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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: EUCTR
Last refreshed on: 11 June 2018
Main ID:  EUCTR2015-001973-42-LT
Date of registration: 27/11/2015
Prospective Registration: Yes
Primary sponsor: Biogen Idec Research Limited
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: 11/02/2016
Target sample size: 200
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001973-42
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Belgium Bulgaria Croatia Kuwait Lithuania Poland United States
Contacts
Name: N/a   
Address:  Innovation House, 70 Norden Road SL6 4AY Maidenhead United Kingdom
Telephone:
Email: cta.submissions@biogen.com
Affiliation:  Biogen Idec Research Limited
Name: N/a   
Address:  Innovation House, 70 Norden Road SL6 4AY Maidenhead United Kingdom
Telephone:
Email: cta.submissions@biogen.com
Affiliation:  Biogen Idec Research Limited
Key inclusion & exclusion criteria
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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Relapsing Remitting Multiple Sclerosis
MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intervention(s)

Product Name: BG00012
Product Code: BG00012
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: Dimethyl Fumarate
CAS Number: 624-49-7
Current Sponsor code: BG00012
Other descriptive name: Dimethyl Fumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 120-

Primary Outcome(s)
Main Objective: 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 RRMS.
Primary end point(s): The primary endpoint is the change in lymphocyte subset counts for up to 48 weeks.
Secondary Objective: A secondary objective is to evaluate the pharmacodynamic effect of BG00012 on absolute lymphocyte counts (ALCs) and Igs during the first year of treatment.
Timepoint(s) of evaluation of this end point: At screening, Day 1, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48
Secondary Outcome(s)
Secondary end point(s): The secondary endpoints are the changes in IgG isotypes and ALCs for up to 48 weeks.
Timepoint(s) of evaluation of this end point: At screening, Day 1, Week 4, Week 8, Week 12, Week 24, Week 36, Week 48
Secondary ID(s)
109MS310
2015-001973-42-BE
Source(s) of Monetary Support
Biogen Idec Research Limited
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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