Advertisement

Topics

Efficacy and Safety of Daclizumab High Yield Process Versus Interferon β 1a in Patients With Relapsing-Remitting Multiple Sclerosis

2014-08-27 03:16:03 | BioPortfolio

Summary

The primary study objective is to test the superiority of DAC HYP compared to IFN β-1a in preventing MS relapse in subjects 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 subject population.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Relapsing Remitting Multiple Sclerosis

Intervention

Daclizumab High Yield Process (DAC HYP) (Active), Interferon beta-1a Placebo, Interferon beta-1a (IFN β-1a) (Active), Daclizumab High Yield Process Placebo

Location

Research Site
Gilbert
Arizona
United States

Status

Active, not recruiting

Source

Biogen Idec

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:03-0400

Clinical Trials [2313 Associated Clinical Trials listed on BioPortfolio]

Phase II Cladribine Add-on to Inteferon-beta (IFN-b) Therapy in MS Subjects With Active Disease

The goal of this study is to evaluate the safety, tolerability and effectiveness of oral cladribine when taken in combination with Interferon-beta therapy for the treatment of MS. This st...

A Multicentre Phase III Study of Interferon-Beta-1a for the Treatment of Chronic Hepatitis C in Asian Patients

The main objective of this study is to establish interferon-beta-1a as the treatment of choice for chronic hepatitis C with better efficacy & safety profiles in monotherapy or combination ...

Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing Remitting Multiple Sclerosis

Extended DAC HYP monotherapy from study 205MS202 in order to evaluate long term safety and efficacy of DAC HYP in subjects with relapsing remitting multiple sclerosis (MS).

BEYOND Follow-up: Betaferon®/Betaseron® Efficacy Yielding Outcomes of a New Dose

The BEYOND Follow-Up study will give patients who participated in the preceding BEYOND study the opportunity to continue treatment with the 500µg dose of interferon beta (IFNB) 1b and wil...

Is IFN-Beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta

This study is to find out if Interferon-beta (IFN-beta) can recover its effectiveness after a washout period in patients with Multiple Sclerosis who have previously developed neutralizing ...

PubMed Articles [27349 Associated PubMed Articles listed on BioPortfolio]

Matching-adjusted comparisons demonstrate better clinical outcomes with SC peginterferon beta-1a every two weeks than with SC interferon beta-1a three times per week.

Subcutaneous (SC) peginterferon beta-1a and SC interferon beta-1a (IFN beta-1a) have demonstrated efficacy in treating relapsing-remitting multiple sclerosis (RRMS) but have never been compared in dir...

Pulmonary Sarcoidosis in a patient with Multiple Sclerosis on daclizumab monotherapy.

As new immunomodulatory therapies continue to be licensed for use in Multiple Sclerosis, it is important to remain vigilant for new, unexpected associations relating to these medications. We highlight...

Process intensification of core streptavidin production through high-cell-density cultivation of recombinant E. coli and a temperature-based refolding method.

An intensified process was developed that enables high level production of recombinant core streptavidin (cSAV), a non-glycosylated tetrameric protein utilised in a wide range of applications. A pH-st...

A case of malignant melanoma that developed multiple metastases after switching from interferon-beta to pegylated interferon-alpha-2b as adjuvant therapy.

Sequential parallel comparison design with binary and time-to-event outcomes.

Sequential parallel comparison design (SPCD) has been proposed to increase the likelihood of success of clinical trials especially trials with possibly high placebo effect. Sequential parallel compari...

Medical and Biotech [MESH] Definitions

Interferon secreted by leukocytes, fibroblasts, or lymphoblasts in response to viruses or interferon inducers other than mitogens, antigens, or allo-antigens. They include alpha- and beta-interferons (INTERFERON-ALPHA and INTERFERON-BETA).

A ubiquitously expressed heterodimeric receptor that is specific for both INTERFERON-ALPHA and INTERFERON-BETA. It is composed of two subunits referred to as IFNAR1 and IFNAR2. The IFNAR2 subunit is believed to serve as the ligand-binding chain; however both chains are required for signal transduction. The interferon alpha-beta receptor signals through the action of JANUS KINASES such as the TYK2 KINASE.

An interferon regulatory factor that binds upstream TRANSCRIPTIONAL REGULATORY ELEMENTS in the GENES for INTERFERON-ALPHA and INTERFERON-BETA. It functions as a transcriptional activator for the INTERFERON TYPE I genes.

An interferon beta-1 subtype that has a methionine at position 1, a cysteine at position 17, and is glycosylated at position 80. It functions as an ANTI-VIRAL AGENT and IMMUNOMODULATOR and is used to manage the symptoms of RELAPSING-REMITTING MULTIPLE SCLEROSIS.

A non-glycosylated form of interferon beta-1 that has a serine at position 17. It is used in the treatment of both RELAPSING-REMITTING MULTIPLE SCLEROSIS and CHRONIC PROGRESSIVE MULTIPLE SCLEROSIS.

More From BioPortfolio on "Efficacy and Safety of Daclizumab High Yield Process Versus Interferon β 1a in Patients With Relapsing-Remitting Multiple Sclerosis"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Spinal Cord Disorders
The spinal cord is a bundle of nerves that runs down the middle of the back which carry signals back and forth between the body and brain. It is protected by vertebrae, which are the bone disks that make up the spine. An accident that damages the verte...

Alzheimer's Disease
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase  'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...

Neurology - Central Nervous System (CNS)
Alzheimer's Disease Anesthesia Anxiety Disorders Autism Bipolar Disorders Dementia Epilepsy Multiple Sclerosis (MS) Neurology Pain Parkinson's Disease Sleep Disorders Neurology is the branch of me...


Searches Linking to this Trial