Relapsing Multiple Sclerosis MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
Conditions
Interventions
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
Pharmaceutical Form: Solution for injection
Current Sponsor code: BIIB017
Other descriptive name: PEGylated Interferon Beta-1a
Concentr
Sponsors
Biogen Idec LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of randomization, Day 1: 1. Ability 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. 2. Aged 18 to 55 years old, inclusive, at the time of informed consent. 3. Must have a confirmed diagnosis of relapsing MS, as defined by McDonald criteria #1-4. 4. Must have an EDSS score between 0.0 and 5.0. 5. Must have experienced at least 2 relapses that have been medically documented within the last 3 years with at least one of these relapses having occurred within the past 12 months prior to randomization (Day 1). 6. All male subjects and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months, after their last dose of study treatment. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of randomization, Day 1: 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 relapse, but are distinguished from relapsing subjects by the lack of clinically stable periods or clinical improvement. 2. History of severe allergic or anaphylactic reactions or known hypersensitivity. 3. Prior treatment with interferon cannot exceed 4 weeks and subjects must have discontinued interferon treatment 6 months prior to Baseline. 4. Known allergy to any component of the BIIB017 formulation. 5. History of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease that would preclude participation in a clinical trial. 6. History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured). 7. History of seizure disorder or unexplained blackouts OR history of a seizure within 3 months prior to Baseline. 8. History of suicidal ideation within 3 months prior to Baseline or an episode of severe depression within 3 months prior to Baseline. Severe depression is defined as an episode of depression that requires hospitalization, or at the discretion of the Investigator. 9. Clinically significant abnormal electrocardiogram (ECG) values as determined by the Investigator. 10. Known history of or positive test result for Human Immunodeficiency Virus (HIV). 11. Positive test result for Hepatitis C virus (test for Hepatitis C virus antibody [HCV Ab]) or Hepatitis B virus (test for Hepatitis B Surface Antigen [HBsAg] and/or Hepatitis B Core Antibody [HBcAb]). 12. Abnormal screening blood tests exceeding any of the limits defined below: • Alanine transaminase/serum glutamate pyruvate transaminase (ALT/SGPT) greater than 2 times the upper limit of normal (>2 × ULN) or aspartate transaminase/serum glutamic oxaloacetic transaminase (AST/SGOT) >2 × ULN or bilirubin >1.5 × ULN. • Total white blood cell count (WBC) ULN • Prothrombin time (PT) or activated partial thromboplastin time (aPTT) >1.2 × ULN 13. An MS relapse that has occurred within the 50 days prior to randomization and/or the subject has not stabilized from a previous relapse prior to randomization (Day 1). Treatment history: 14. Any previous treatment with BIIB017. 15. History of hypersensitivity or intolerance to acetaminophen (paracetamol), ibuprofen, naproxen, or aspirin that would preclude use of at least one of these during the study. 16. Treatment with other agents to treat MS symptoms or underlying disease as specified in Table P.43 in protocol. 17. Treatment with another investigational drug or approved therapy for investigational use within the 6 months prior to randomization (Day 1). Miscellaneous 18. Female subjects considering becoming pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the efficacy of BIIB017 in reducing the Annualized Relapse Rate (ARR) in subjects with RMS at 1 year.;Secondary Objective: The secondary objectives of this study are to determine, whether BIIB017, at 1 year when compared with placebo, is effective in: • reducing the total number of new or newly enlarging T2 hyperintense lesions on brain MRI scans • reducing the proportion of subjects who relapsed • improving quality of life as measured by the Multiple Sclerosis Impact Scale-29 (MSIS-29) physical score • slowing the progression of disability as measured by at least a 1.0 point increase on the Expanded Disability Status Scale (EDSS) from baseline EDSS = 1.0 that is sustained for 12 weeks, or at least a 1.5 point increase on the EDSS from baseline EDSS = 0 that is sustained for 12 weeks;Primary end point(s): The primary objective of this study is to determine the efficacy of BIIB017 in reducing the Annualized Relapse Rate (ARR) in subjects with relapsing Multiple Sclerosis (MS) at 1 year. | — |
Countries
Belgium, Bulgaria, Czech Republic, Estonia, Germany, Greece, Latvia, Netherlands, Spain, United Kingdom
Outcome results
None listed