A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Relapsing Multiple Sclerosis

In brief

To evaluate the safety and tolerability of atacicept and to explore if atacicept reduces central nervous system inflammation in subjects with relapsing multiple sclerosis (RMS) as assessed by frequent magnetic resonance imaging (MRI). This study is randomised. Study medication is administered via subcutaneous (under the skin) injections.

Key facts

Study ID

NCT00642902

Run by

EMD Serono

People needed

255

Starts

2008-04-01

Expected to finish

2009-09-01

Last updated by the study team

2016-05-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of RMS (as per McDonald criteria, 2005) Other protocol-defined inclusion criteria could apply.

You may not qualify if…

• Have primary progressive multiple sclerosis (MS)
• Have secondary progressive MS without superimposed relapses
• Relevant cardiac, hepatic and renal diseases as specified in the protocol
• Pretreatment with immunosuppressants and immunomodulating drugs as specified in the protocol
• Clinical significant abnormalities in blood cell counts and immunoglobulin levels as specified in the protocol
• Clinical significant acute or chronic infections as specified in the protocol Other protocol-defined exclusion criteria could apply.

Where it is running

• Research Site — Phoenix, Arizona, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Northbrook, Illinois, United States
• Research Site — East Lansing, Michigan, United States
• Research Site — Jefferson, New Hampshire, United States
• Research Site — Cleveland, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Box Hill, Australia
• Research Site — Fitzroy, Australia
• Research Site — New Lambton, Australia
• Research Site — Woodville, Australia
• Research Site — Innsbruck, Austria
• Research Site — Diepenbeek, Belgium
• Research Site — Sijsele, Belgium
• Research Site — Calgary, Alberta, Canada
• Research Site — Ottawa, Ontario, Canada
• Research Site — Ontario, Canada
• Research Site — Brno, Czechia
• Research Site — Hradec Králové, Czechia
• Research Site — Olomouc, Czechia
• Research Site — Caen, France
• Research Site — Saint-Herblain, France
• Research Site — Bochum, Germany
• Research Site — Düsseldorf, Germany

Full record on ClinicalTrials.gov

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