Atacicept in Multiple Sclerosis, Phase II

This study has been terminated.
(EMD Serono voluntarily decided to terminate this trial after observing increased MS disease activity in the atacicept treatment groups compared to placebo)
Sponsor:
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT00642902
First received: March 21, 2008
Last updated: April 22, 2011
Last verified: April 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:


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
Study Completion Date: February 2011
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
High-dose treatment with Atacicept
Drug: atacicept
Atacicept high, mid and low-dose, respectively
Experimental: 2
Mid-dose treatment with Atacicept
Drug: atacicept
Atacicept high, mid and low-dose, respectively
Experimental: 3
Low dose treatment with Atacicept
Drug: atacicept
Atacicept high, mid and low-dose, respectively
Placebo Comparator: 4
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
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
Research Site
Box Hill, Australia
Research Site
Fitzroy, Australia
Research Site
New Lambton, Australia
Research Site
Woodville, Australia
Austria
Research Site
Innsbruck, Austria
Belgium
Research Site
Diepenbeek, Belgium
Research Site
Sijsele, Belgium
Canada, Alberta
Research Site
Calgary, Alberta, Canada
Canada, Ontario
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Ottawa, Ontario, Canada
Canada
Research Site
Ontario, Canada
Czech Republic
Research Site
Brno, Czech Republic
Research Site
Hradec Kralove, Czech Republic
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Olomouc, Czech Republic
France
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Caen, France
Research Site
Saint-Herblain, France
Germany
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Bochum, Germany
Research Site
Dusseldorf, Germany
Lebanon
Research Site
Beirut, Lebanon
Research Site
Beyrouth, Lebanon
Lithuania
Research Site
Kaunas, Lithuania
Netherlands
Research Site
Breda, Netherlands
Research Site
Nieuwegein, Netherlands
Research Site
Rotterdam, Netherlands
Russian Federation
Research Site
Dnipropetrovsk, Russian Federation
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Ekaterinburg, Russian Federation
Research Site
Moscow, Russian Federation
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Novosibirsk, Russian Federation
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Saint Petersburg, Russian Federation
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Samara, Russian Federation
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Vladimir, Russian Federation
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Yaroslavl, Russian Federation
Spain
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Barcelona, Spain
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Madrid, Spain
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Malaga, Spain
Sweden
Research Site
Stockholm, Sweden
Switzerland
Research Site
Basel, Switzerland
Ukraine
Research Site
Kharkiv, Ukraine
Research Site
Kyiv, Ukraine
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Odessa, Ukraine
Research Site
Uzhgorod, Ukraine
United Kingdom
Research Site
London, United Kingdom
Research Site
Sheffield, 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:
No publications provided

Responsible Party: Lynne Macgregor, Merck Serono S.A. - Geneva an Affiliate of Merck KGaA Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT00642902     History of Changes
Other Study ID Numbers: 28063
Study First Received: March 21, 2008
Last Updated: April 22, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014