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

March 21, 2008
April 22, 2011
March 2008
September 2009   (final data collection date for primary outcome measure)
Mean number of T1 gadolinium (Gd)-enhancing lesions per subject per scan. [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00642902 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Atacicept in Multiple Sclerosis, Phase II
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)

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Relapsing Multiple Sclerosis
  • Drug: atacicept
    Atacicept high, mid and low-dose, respectively
  • 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)."
  • Experimental: 1
    High-dose treatment with Atacicept
    Intervention: Drug: atacicept
  • Experimental: 2
    Mid-dose treatment with Atacicept
    Intervention: Drug: atacicept
  • Experimental: 3
    Low dose treatment with Atacicept
    Intervention: Drug: atacicept
  • Placebo Comparator: 4
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
292
February 2011
September 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   Czech Republic,   France,   Germany,   Lebanon,   Lithuania,   Netherlands,   Russian Federation,   Spain,   Sweden,   Switzerland,   Ukraine,   United Kingdom
 
NCT00642902
28063
Not Provided
Lynne Macgregor, Merck Serono S.A. - Geneva an Affiliate of Merck KGaA Darmstadt, Germany
EMD Serono
Not Provided
Study Director: Dan Mikol, MD, PhD EMD Serono
EMD Serono
April 2011

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