Atacicept in Multiple Sclerosis, Phase II - Full Text View

Sponsor:	EMD Serono
Information provided by:	EMD Serono
ClinicalTrials.gov Identifier:	NCT00642902

Purpose

To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces Central Nervous System inflammation in subjects with RMS as assessed by frequent MRI. This study is randomised. Study medication is administered via subcutaneous (under the skin) injections.

Condition	Intervention	Phase
Relapsing Multiple Sclerosis	Drug: atacicept Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	A Randomised, Double-blind, Placebo-controlled, Multicentre Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of Three Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS)

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

U.S. FDA Resources

Further study details as provided by EMD Serono:

Primary Outcome Measures:

Mean number of T1 gadolinium (Gd)-enhancing lesions per subject per scan. [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of new T1 hypointense lesions, Proportion of subjects free from relapses during the 36-week treatment period, Nature, severity, and incidence of adverse events and infections [ Time Frame: weeks 12, 24, 36 ] [ Designated as safety issue: No ]

Estimated Enrollment:	292
Study Start Date:	March 2008
Estimated Study Completion Date:	December 2010
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental High-dose treatment with Atacicept	Drug: atacicept Atacicept high, mid and low-dose, respectively
2: Experimental Mid-dose treatment with Atacicept	Drug: atacicept Atacicept high, mid and low-dose, respectively
3: Experimental Low dose treatment with Atacicept	Drug: atacicept Atacicept high, mid and low-dose, respectively
4: Placebo Comparator Placebo	Drug: Placebo Placebo will be supplied in a transparent, sterile solution for injection in pre-filled syringes matching the Atacicept pre-filled syringes, each containing 1mL. The placebo formulation to be used in this study contains trehalose and 10 mmol sodium acetate buffer (pH 5)."

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of Relapsing Multiple Sclerosis (per McDonald criteria, 2005);

Exclusion Criteria:

Have primary progressive MS.
Have secondary progressive MS without superimposed relapses.
Relevant cardiac, hepatic and renal diseases
Pre treatment with immunosuppressants and immunomodulating drugs
Clinical significant abnormalities in blood cell counts and Ig levels
Clinical significant acute or chronic infections.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642902

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Locations

United States, Arizona
Research Site
Phoenix, Arizona, United States
United States, Georgia
Research Site
Atlanta, Georgia, United States
United States, Illinois
Research Site
Northbrook, Illinois, United States
United States, Michigan
Research Site
East Lansing, Michigan, United States
United States, New Hampshire
Research Site
Dartmouth, New Hampshire, United States
United States, Ohio
Research Site
Cleveland, Ohio, United States
United States, Pennsylvania

Philadelphia, Pennsylvania, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States
Australia
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Woodville, Australia
Research Site
New Lambton, Australia
Research Site
Fitzroy, Australia
Research Site
Box Hill, Australia
Austria
Research Site
Innsbruck, Austria
Belgium
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Diepenbeek, Belgium
Research Site
Sijsele, Belgium
Canada
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Ontario, Canada
Canada, Alberta
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Calgary, Alberta, Canada
Canada, Ontario
Research Site
Ottawa, Ontario, Canada
Czech Republic
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Hradec Kralove, Czech Republic
Research Site
Olomouc, Czech Republic
Research Site
Brno, Czech Republic
France
Research Site
Saint-Herblain, France
Research Site
Caen, France
Germany
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Dusseldorf, Germany
Research Site
Bochum, Germany
Lebanon
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Beyrouth, Lebanon
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Beirut, Lebanon
Lithuania
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Kaunas, Lithuania
Netherlands
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Rotterdam, Netherlands
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Nieuwegein, Netherlands
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Breda, Netherlands
Russian Federation
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Moscow, Russian Federation
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Saint Petersburg, Russian Federation
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Samara, Russian Federation
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Yaroslavl, Russian Federation
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Ekaterinburg, Russian Federation
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Novosibirsk, Russian Federation
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Vladimir, Russian Federation
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Dnipropetrovsk, Russian Federation
Spain
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Madrid, Spain
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Barcelona, Spain
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Malaga, Spain
Sweden
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Stockholm, Sweden
Switzerland
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Basel, Switzerland
Ukraine
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Kyiv, Ukraine
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Odessa, Ukraine
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Uzhgorod, Ukraine
Research Site
Kharkiv, Ukraine
United Kingdom
Research Site
Sheffield, United Kingdom
Research Site
London, United Kingdom
Research Site
Stoke on Trent, United Kingdom

Sponsors and Collaborators

EMD Serono

Investigators

Study Director:

Dan Mikol, MD, PhD

EMD Serono

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck Serono S.A. - Geneva an Affiliate of Merck KGaA Darmstadt, Germany ( Lynne Macgregor )
Study ID Numbers:	28063
Study First Received:	March 21, 2008
Last Updated:	September 25, 2009
ClinicalTrials.gov Identifier:	NCT00642902 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Pathologic Processes
Autoimmune Diseases
Multiple Sclerosis
Immune System Diseases
Demyelinating Diseases

Nervous System Diseases
Demyelinating Autoimmune Diseases, CNS
Sclerosis
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on November 27, 2009