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NCT00642902 Clinical Trial

Atacicept in Multiple Sclerosis, Phase II

Relapsing Multiple Sclerosis Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00642902
Other study ID # 28063
Secondary ID
Status Terminated
Phase Phase 2
First received March 21, 2008
Last updated April 22, 2011
Start date March 2008
Est. completion date February 2011

Study information
Verified date April 2011
Source EMD Serono
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 292
Est. completion date February 2011
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• atacicept
Atacicept high, mid and low-dose, respectively
• 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)."

Locations
Country Name City State
Australia Research Site Box Hill
Australia Research Site Fitzroy
Australia Research Site New Lambton
Australia Research Site Woodville
Austria Research Site Innsbruck
Belgium Research Site Diepenbeek
Belgium Research Site Sijsele
Canada Research Site Calgary Alberta
Canada Research Site Ontario
Canada Research Site Ottawa Ontario
Czech Republic Research Site Brno
Czech Republic Research Site Hradec Kralove
Czech Republic Research Site Olomouc
France Research Site Caen
France Research Site Saint-Herblain
Germany Research Site Bochum
Germany Research Site Dusseldorf
Lebanon Research Site Beirut
Lebanon Research Site Beyrouth
Lithuania Research Site Kaunas
Netherlands Research Site Breda
Netherlands Research Site Nieuwegein
Netherlands Research Site Rotterdam
Russian Federation Research Site Dnipropetrovsk
Russian Federation Research Site Ekaterinburg
Russian Federation Research Site Moscow
Russian Federation Research Site Novosibirsk
Russian Federation Research Site Saint Petersburg
Russian Federation Research Site Samara
Russian Federation Research Site Vladimir
Russian Federation Research Site Yaroslavl
Spain Research Site Barcelona
Spain Research Site Madrid
Spain Research Site Malaga
Sweden Research Site Stockholm
Switzerland Research Site Basel
Ukraine Research Site Kharkiv
Ukraine Research Site Kyiv
Ukraine Research Site Odessa
Ukraine Research Site Uzhgorod
United Kingdom Research Site London
United Kingdom Research Site Sheffield
United Kingdom Research Site Stoke on Trent
United States Research Site Atlanta Georgia
United States Research Site Cleveland Ohio
United States Research Site Dartmouth New Hampshire
United States Research Site East Lansing Michigan
United States Research Site Nashville Tennessee
United States Research Site Northbrook Illinois
United States Research Site Phoenix Arizona

Sponsors (1)
Lead Sponsor Collaborator
EMD Serono

Countries where clinical trial is conducted

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

Outcome
Type Measure Description Time frame Safety issue
Primary Mean number of T1 gadolinium (Gd)-enhancing lesions per subject per scan. up to 48 weeks No
Secondary 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 weeks 12, 24, 36 No
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