Atacicept in Multiple Sclerosis, Phase II - Full Text View

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

MedlinePlus related topics:

Multiple Sclerosis

ChemIDplus related topics:

Sodium acetate Acetic acid, sodium salt

U.S. FDA Resources

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)

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:	April 2010
Estimated Primary Completion Date:	March 2010 (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

Contacts


Contact: Lynne Macgregor	+41 22 414 4752	Lynne.Macgregor@merckserono.net

Show 17 Study Locations

Sponsors and Collaborators

EMD Serono

ZymoGenetics

Investigators


Study Director:	Bruno Musch, MD, PhD	Merck Serono International S.A., an affiliate of Merck KGaA, Darmstadt, Germany

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Merck Serono International S.A. ( Lynne Macgregor )
Study ID Numbers:	28063
First Received:	March 21, 2008
Last Updated:	July 30, 2008
ClinicalTrials.gov Identifier:	NCT00642902
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Morphine

Autoimmune Diseases

Multiple Sclerosis

Demyelinating Diseases

Demyelinating Autoimmune Diseases, CNS

Demyelinating diseases

Sclerosis

Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Pathologic Processes

Immune System Diseases

Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2008

Sponsors and Collaborators:	EMD Serono ZymoGenetics
Information provided by:	EMD Serono
ClinicalTrials.gov Identifier:	NCT00642902