Safety and Efficacy Study of Daclizumab HYP to Treat Relapsing-Remitting Multiple Sclerosis - Full Text View

Sponsor:	Biogen Idec
Collaborator:	Abbott Biotherapeutics Corp.
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00390221

Purpose

The purpose of this study is to determine the effect of 2 different doses of daclizumab on reducing relapses in subjects with relapsing-remitting MS.

Condition	Intervention	Phase
Multiple Sclerosis, Relapsing-remitting	Drug: daclizumab HYP Other: placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects With Relapsing-Remitting Multiple Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Dacliximab

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:

Annualized Relapse Rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

brain MRI measures (number of gd-enhancing lesions, number of new or newly-enlarging T2 hyperintense lesions) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
proportion of relapsing subjects [ Time Frame: 1 year ] [ Designated as safety issue: No ]
improving quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment:	621
Study Start Date:	February 2008

Arms	Assigned Interventions
Placebo Comparator: 1 subcutaneous (SC)	Other: placebo SC
Experimental: 2 daclizumab HYP SC	Drug: daclizumab HYP SC injection, 150 mg and 300 mg every 4 weeks for 48 weeks
Experimental: 3 daclizumab HYP SC	Drug: daclizumab HYP SC injection, 150 mg and 300 mg every 4 weeks for 48 weeks

Detailed Description:

Multiple sclerosis (MS) is a chronic disease of the central nervous system that affects approximately 400,000 persons in North America and 365,000 persons in Europe. Daclizumab HYP (DAC HYP) is being co-developed by Biogen Idec Inc. (Biogen Idec) and Abbott Biotherapeutics for treatment of MS. Daclizumab (DAC) produced using the Abbott Biotherapeutics high-yield process is being investigated as an alternative to more toxic immunosuppressive therapies. This study will determine if DAC is safe and efficacious in subjects with relapsing-remitting multiple sclerosis (MS). A dose exploration placebocontrolled study will be performed. Proof of profile will be sought that targeting of the alpha chain of the interleukin-2 receptor (IL-2Ralpha) without concomitant interferon (IFN) is effective in subjects with relapsing-remitting MS.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

MS subjects who have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 and a baseline EDSS between 0.0 and 5.0, inclusive, who meet either of the following 2 criteria:
- Have experienced at least 1 relapse within the 12 months prior to randomization, with a cranial MRI demonstrating lesion(s) consistent with MS , OR
- Show evidence of gadolinium-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390221

Show 76 Study Locations

Sponsors and Collaborators

Biogen Idec

Abbott Biotherapeutics Corp.

More Information

Additional Information:

(MSActiveSource.com is a resource for news, information, and disease management for all individuals touched by Multiple Sclerosis. This site is sponsored by Biogen Idec.) This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

(The website of the National Multiple Sclerosis Society, an organization dedicated to providing information to individuals with MS, their families, and healthcare providers.) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Biogen Idec MD, Biogen Idec, Inc.
ClinicalTrials.gov Identifier:	NCT00390221 History of Changes
Other Study ID Numbers:	205-MS-201
Study First Received:	October 17, 2006
Last Updated:	July 14, 2011
Health Authority:	Ukraine: State Pharmacological Center - Ministry of Health; Czech Republic: State Institute for Drug Control; Hungary: National Institute of Pharmacy; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; India: Drugs Controller General of India; Turkey: Ministry of Health; Germany: Paul-Ehrlich-Institut; Russia: Ministry of Health and Social Development of the Russian Federation

Keywords provided by Biogen Idec:

MS
multiple sclerosis

Additional relevant MeSH terms:

Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases

Immune System Diseases
Pathologic Processes
Daclizumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012