Phase 3 Efficacy and Safety Study of BG00012 in Subjects Withrelapsing-remitting multiple sclerosis (RRMS).
- Conditions
- Relapsing-Remitting Multiple SclerosisMedDRA version: 20.0Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2013-002318-11-PL
- Lead Sponsor
- Biogen Idec Research Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 132
Key inclusion criteria:
1. Ability of parents or legal guardians to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations. Subjects will provide assent in addition to the parental or guardian consent, as appropriate, as per local regulations.
2. Males and females aged from 10 to less than 18 years old (from 14 to less than 18 years old in Poland) at the time of informed consent or assent.
3. Must have a body weight of =30 kg (=40 kg in Poland).
4. Must have a diagnosis of RRMS (consensus definition for pediatric RRMS [Krupp 2007]).
5. Must be ambulatory with a baseline EDSS score between 0 and 5.5, inclusive.
6. Must have experienced at least 1 relapse within the last 12 months prior to Day 1 or at least 2 relapses within the last 24 months prior to Day 1, with a prior brain MRI demonstrating lesions consistent with MS, or evidence of Gd-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to Day 1.
7. Must be neurologically stable, with no evidence of relapse within 50 days prior to Day 1 and no evidence of corticosteroid treatment within 30 days prior to Day 1.
8. Subjects of childbearing potential who are sexually active must be willing to practice effective contraception during the study and be willing and able to continue contraception for at least 30 days after their final dose of study treatment.
Part 2;
- Subjects who have completed week 96 in Part 1
NOTE: Other protocol defined inclusion criteria may apply
Are the trial subjects under 18? yes
Number of subjects for this age range: 132
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Key exclusion criteria:
Medical history
1. Primary progressive, secondary progressive, or progressive relapsing MS (as defined by [Lublin and Reingold 1996]). These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Subjects with these conditions may also have superimposed relapses but are distinguished from relapsing-remitting subjects by the lack of clinically stable periods or clinical improvement.
2. Disorders mimicking MS, such as other demyelinating disorders (e.g., acute disseminated encephalomyelitis), systemic autoimmune disorders (e.g., Sjögren disease, lupus erythematosus), metabolic disorders (e.g., dystrophies), and infectious disorders.
3. History of premalignant or malignant disease. Subjects with basal cell carcinoma that has been completely excised prior to screening will remain eligible
4. History of severe allergic or anaphylactic reactions, or known drug hypersensitivity to DMF,fumaric acid esters or interferon ß-1a (IFN ß-
1a)
5. History of abnormal laboratory results indicative of any significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, renal, and/or any other major disease that would preclude participation in a clinical study
6. History of clinically significant cardiovascular, pulmonary, GI, dermatologic, growth, developmental, psychiatric (including depression), neurologic (other than MS), and/or other major disease that would preclude participation in a clinical study
7. History of human immunodeficiency virus
8. History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to Day 1.
9. An MS relapse that has occurred within 50 days prior to Day 1 AND/OR the subject has not stabilized from a previous relapse prior to Day 1
10. History or positive test result at Screening for hepatitis C virus antibody or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]). Subjects with immunity to hepatitis B from either active vaccination (defined as negative HBsAg, positive hepatitis B surface antibody [HBsAb] and negative HBcAb) or from previous natural infection (defined as negative HBsAg, positive HBsAb IgG, and positive HBcAb) are eligible to participate in the study (definitions are based on the Centers for Disease Control and Prevention [CDC]’s interpretation of the hepatitis B serology panel [CDC 2007]; Appendix 4, Section 25]).
11. Any of the following abnormal blood test results at Screening:
? ALT, AST, or gamma-glutamyl-transferase (GGT) =2 × ULN
? leukocytes <3500/mm3
? eosinophils >0.7 × 103/µL or >0.7 GI/L
? absolute lymphocyte count 12. Any of the following abnormal urine tests at Screening confirmed by a second urinalysis approximately 2 weeks later:
? proteinuria (1+ or greater) and/or spot protein/creatinine ratio (with AM void) >0.2 mg. Note: Documented benign proteinuria is not exclusionary.
? hematuria, without known etiology
? glycosuria, without known etiology
Note: If a subject has a positive test at Screening and the etiology is known (e.g., due to menses or urinary tract infection in the case of hematuria or due to recent steroid use or elevated serum glucose in the case of glycosuria), a repeat test is not required.
Treatment history
13. Any previous treatment with Fumaderm® or BG00012.
14. Prior treatment with any of the following:
? total lymphoid irradiation
? cl
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objectives of Part 1 are as follows:<br>• To evaluate the safety, tolerability, and efficacy on the disease course<br>of BG00012 (dimethyl fumarate) in subjects with RRMS, as compared<br>with a disease modifying treatment..<br>• To assess health outcomes and evolution of disability<br><br>The primary objective of Part 2 is to evaluate the long-term safety of<br>BG00012 in subjects who completed week 96 in Part 1 of Study 109MS306.;Secondary Objective: Not Applicable;Primary end point(s): The primary endpoint of Part 1 is the proportion of subjects free of new or newly enlarging T2 hyperintense lesions on brain MRI scans at Week 96.<br><br>The primary endpoint of the Part 2 is the incidence of adverse events, serious adverse events and discontinuations of BG00012 due to an adverse event;Timepoint(s) of evaluation of this end point: Part 1 - Day 1 (baseline visit), weeks 24, 48, 72, 96<br><br>Part 2 - up to week 244
- Secondary Outcome Measures
Name Time Method