A Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis
- Conditions
- MedDRA version: 14.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]Relapsing Multiple Sclerosis
- Registration Number
- EUCTR2008-006333-27-GB
- Lead Sponsor
- Biogen Idec Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 1516
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 65 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 1425
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75
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 Human Immunodeficiency Virus (HIV).
11. Known history or positive test result for hepatitis C antibody (HCV Ab), or current hepatitis B infection (defined as positive for hepatitis B surface antigen [HBsAg] and/or positive for hepatitis B core antibody [HBcAb]) at Screening. Subjects with immunity to hepatitis B from either active vaccination or from previous natural infection are eligible to participate in the study
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) < 3,700 /mm3
• Absolute Neutrophil Count (ANC) of < 1,500 /mm3
• Platelet count <150,000 c/mm3
• Hemoglobin <10 g/dL in female subjects; <11 g/dL in male subjects
• Serum creatinine >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 into
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method