None listed
Conditions
Interventions
Group 1 Type of group
Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 or 4 weeks for 48 weeks.
Group name:Group 3 Type of group
125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 96 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
Sponsors
Biogen Idec, Inc.,
Eligibility
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: • Ability to understand the purpose and risks of the study, give your signed and dated informed consent and authorization to use protected health information (PHl) in accordance with national and local patient privacy regulations. • Age between 18 and 55 years, inclusive, at the time of informed consent. • They must have a confirmed diagnosis of recurrent remitting MS, as defined by McDonald´s criteria # 1-4 (Polman et al, 2005; [Appendix 1]). • They must have an EDSS score between 0.0 and 5.0. • They must have experienced at least 2 medically documented relapses within the last 3 years with at least one of these relapses occurring within the last 12 months before randomization (Day I). • All male and female patients of childbearing age should use effective methods of contraception during the study; they must be willing and able to continue with the method of contraception for 3 months, after their last dose of study treatment. For additional details on the contraceptive requirements of this study, please see Section 15.5.3.
Exclusion criteria
Exclusion criteria: • Primary progressive, progressive secondary or progressive MS with relapse (as defined by Lublin and Reingold, 1996; (Appendix 2). These diseases require the presence of a continuous worsening of the clinical disease over a period of at least 3 months. Patients with these diseases may also have an overlapping relapse, but patients who relapse differ by the lack of clinically stable periods or clinical improvement. • History of severe allergy or anaphylactic reactions or known hypersensitivity • Previous treatment with interferon cannot exceed 4 weeks and patients must have discontinued interferon treatment 6 months before the baseline period. • Known allergy to any of the components of the BIIB017 formulation. • History of any clinically significant disease (as determined by the Researcher) such as heart disease, endocrine, immune, metabolic, urological, pulmonary, dermatological, psychiatric and renal neurological or other serious diseases that would exclude participation in a clinical study. • History of malignant disease, including solid tumors and hematologic malignancies (except basal cell carcinoma and squamous cell carcinoma of the skin that have been completely removed and considered cured). • History of seizure disorders or unexplained fainting Or a history of seizures within 3 months prior to the Baseline period. • History of suicidal ideas within 3 months prior to the Basal period or an episode of severe depression within 3 months prior to the Basal period A severe depression is defined as an episode of depression that requires hospitalization, or according to the Investigator´s criteria. • Clinically significant values ​​of the abnormal electrocardiogram (ECG) as determined by the investigator. • Known history or positive results for Human Immunodeficiency Virus (HIV). • Positive result for the analysis of Hepatitis C virus (analysis for hepatitis C antibodies [HCV Ab]) or Hepatitis B virus (analysis for Hepatitis B Surface Antigen [HBsAg) and / or central antibody of Hepatitis B [HBcAb]) • Abnormal blood tests in the selection period. • A relapse of MS that occurred within 50 days prior to randomization and / or the patient did not stabilize from a relapse prior to randomization (Day 1). • Any previous treatment with BIIB017. • History of hypersensitivity or intolerance to paracetamol (paracetamol), ibuprofen, naproxen or aspirin that would exclude the use of at least one of these medications during the study. • Treatment with other agents to treat the symptoms of MS or underlying disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by an independent neurology evaluation committee (INEC) are included in the analysis. Data after participants switched to alternative multiple sclerosis (MS) medications are excluded. Data were analyzed using negative binomial regression, adjusted for baseline Expanded Disability Status Scale (EDSS) score (< 4 versus ≥ 4), baseline age (< 40 versus ≥ 40 years), and baseline relapse rate (number of relapses in 3 years prior to study entry divided by 3). Measure:Annualized Relapse Rate (ARR) at 1 Year Timepoints:1 Year | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans. Data observed after participants switched to alternative MS medications are excluded. Adjusted mean is based on negative binomial regression, adjusted for baseline number of T2 lesions. Measure:Number of New Or Newly Enlarging T2 Hyperintense Lesions at 1 Year Timepoints:1 Year ; Outcome name:A relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting for at least 24 hours, and accompanied by new objective neurologic findings. Only relapses confirmed by INEC were included in the analysis. Estimated proportion of participants relapsed is based on the Kaplan-Meier product limit method. Measure:Proportion of Participants Relapsed at 1 Year Timepoints:1 year ; Outcome name:Sustained disability progression is defined as: at least a 1.0 point increase on the 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. The EDSS measures the disability status of people with MS on a scale that ranges from 0 to 10. The range of main categories include 0 (normal neurologic examination), to 5 (ambulatory without aid or rest for 200 meters/disability severe enough to impair full daily activities), to 10 (death due to MS). Estimated proportion of participants with progression based on the Kaplan-Meier product limit method. Measure:Estimated Proportion of Participants With Sustained Disability Progression at 1 Year Timepoints:1 Year | — |
Countries
Belgium, Bulgaria, Czech Republic, Estonia, Germany, Greece, Latovia, Netherlands, Spain, United Kindgdom
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed