Atacicept in Multiple Sclerosis, Phase II - Tabular View

Tracking Information

First Received Date ^ICMJE

March 21, 2008

Last Updated Date

September 25, 2009

Start Date ^ICMJE

March 2008

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00642902 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Atacicept in Multiple Sclerosis, Phase II

Official Title ^ICMJE

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)

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment

Condition ^ICMJE

Relapsing Multiple Sclerosis

Intervention ^ICMJE

Drug: atacicept
Drug: Placebo

Study Arms / Comparison Groups

Experimental: High-dose treatment with Atacicept
Experimental: Mid-dose treatment with Atacicept
Experimental: Low dose treatment with Atacicept
Placebo Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

292

Estimated Completion Date

December 2010

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Austria, Belgium, Canada, Czech Republic, France, Germany, Lebanon, Lithuania, Netherlands, Russian Federation, Spain, Sweden, Switzerland, Ukraine, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00642902

Responsible Party

Lynne Macgregor, Merck Serono S.A. - Geneva an Affiliate of Merck KGaA Darmstadt, Germany

Study ID Numbers ^ICMJE

28063

Study Sponsor ^ICMJE

EMD Serono

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Dan Mikol, MD, PhD

EMD Serono

Information Provided By

EMD Serono

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP