Multicenter, Double-blind, Randomized, Parallel-group, Mo... | EligiMed

Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) Versus Avonex® (Interferon β 1a) in Patients With Relapsing-Remitting Multiple Sclerosis

CompletadoFase 3ClinicalTrials.gov

ID: NCT01064401Tipo: INTERVENTIONALInicio: 1 de may de 2010Fin estimado: 1 de jul de 2014

Traducción no disponible, mostrando original

Resumen

The primary study objective is to test the superiority of Daclizumab High Yield Process (DAC HYP) compared to interferon β 1a (IFN β-1a) in preventing multiple sclerosis (MS) relapse in participants with relapsing remitting multiple sclerosis. The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a in slowing functional decline and disability progression and maintaining quality of life in this participant population.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 55 YearsSexo: ALL

Criterios de inclusión

Must have a confirmed diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS), and a cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS
Must have a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive
Male subjects and female subjects of childbearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment

Criterios de exclusión

Exposure to varicella zoster virus within 21 days before screening
Known intolerance, contraindication to, or history of non-compliance with Avonex® 30 µg
History of treatment with Daclizumab High Yield Process (Dac HYP)
History of malignancy
History of severe allergic or anaphylactic reactions
Known hypersensitivity to study drugs or their excipients
History of abnormal laboratory results indicative of any significant disease
History of human immunodeficiency virus (HIV) or other immunodeficient conditions
History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization
History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Baseline
History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 3 months prior to Day 1
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
Known history of, or positive screening test result for hepatitis C virus or hepatitis B virus
Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before screening

Intervenciones

biological

BIIB019 (Daclizumab High Yield Process)

Daclizumab High Yield Process for subcutaneous injection

drug

Interferon beta-1a Placebo

Placebo to interferon beta-1a intramuscular injection

biological

Interferon beta-1a

Interferon beta-1a for intramuscular injection

drug

Daclizumab High Yield Process Placebo

Placebo to Daclizumab High Yield Process subcutaneous injection

Ubicaciones

Research Site

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Research Site

Godoy Cruz, Mendoza Province, Argentina

Research Site

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalBiogen

ColaboradorAbbVie

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