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

This study has been terminated.
(Sponsor voluntarily decided to terminate trial due to increased MS disease activity in atacicept arms as compared to placebo during a routine IDMC review.)
Information provided by (Responsible Party):
EMD Serono Identifier:
First received: March 21, 2008
Last updated: April 15, 2016
Last verified: April 2016
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.

Condition Intervention Phase
Relapsing Multiple Sclerosis Drug: Atacicept Drug: Placebo matched to atacicept Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Four-Arm Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study to Evaluate the Safety, Tolerability and Efficacy as Assessed by Frequent MRI Measures of 3 Doses of Atacicept Monotherapy in Subjects With Relapsing Multiple Sclerosis (RMS) Over a 36 Week Treatment Course

Resource links provided by NLM:

Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan [ Time Frame: Weeks 12 to 36 ]
    Analysis of T1 Gd-enhancing lesions was done using magnetic resonance imaging (MRI) scans. Only post-baseline scans were included in the calculation of this endpoint (excluding the Study Day 1 scan which had been conducted before first dosing).

Secondary Outcome Measures:
  • Number of New T1 Gd-enhancing Lesions Per Participant [ Time Frame: Weeks 12, 24, 36 ]
    Analysis of new T1 Gd-enhancing lesions was done using MRI scans.

  • Percentage of Participants Free From Relapses [ Time Frame: Baseline up to Week 36 ]
    A relapse was defined as the fulfillment of all the following criteria: a) neurological abnormality, either newly appearing or re-appearing, with abnormality specified by both i) neurological abnormality separated by at least 30 days from onset of a preceding clinical event, and ii) neurological abnormality lasting for at least 24 hours; b) absence of fever or known infection (fever with temperature [axillary, orally, or intrauriculary] greater than (>) 37.5 degrees Celsius or 99.5 degrees Fahrenheit); and c) objective neurological impairment, correlating with the participant's reported symptoms, defined as either i) increase in at least 1 of the functional systems of the Expanded Disability Status Scale (EDSS), or ii) increase of the total EDSS score. Percentage of participants free from relapses during 36-week treatment period was reported.

  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs [ Time Frame: From the first dose of study drug administration up to 12 weeks after the last dose of the study drug ]
    An AE was defined as any new untoward medical occurrences/worsening of pre-existing medical condition without regard to possibility of causal relationship. An SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect. Treatment-emergent are events between first dose of study drug up to 12 weeks after the last dose of the study drug that were absent before treatment or that worsened relative to pretreatment state. Number of subjects with TEAEs included subjects with both non serious and serious TEAEs.

Enrollment: 255
Study Start Date: April 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atacicept 25 mg Drug: Atacicept
Atacicept will be administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 32 weeks.
Experimental: Atacicept 75 mg Drug: Atacicept
Atacicept will be administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 32 weeks.
Experimental: Atacicept 150 mg Drug: Atacicept
Atacicept will be administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 32 weeks.
Placebo Comparator: Placebo Drug: Placebo matched to atacicept
Placebo matched to atacicept will be administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 32 weeks.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  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 identifier: NCT00642902

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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
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Nashville, Tennessee, United States
Research Site
Box Hill, Australia
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Fitzroy, Australia
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New Lambton, Australia
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Woodville, Australia
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Innsbruck, Austria
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Diepenbeek, Belgium
Research Site
Sijsele, Belgium
Canada, Alberta
Research Site
Calgary, Alberta, Canada
Canada, Ontario
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Ottawa, Ontario, Canada
Research Site
Ontario, Canada
Czech Republic
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Brno, Czech Republic
Research Site
Hradec Kralove, Czech Republic
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Olomouc, Czech Republic
Research Site
Caen, France
Research Site
Saint-Herblain, France
Research Site
Bochum, Germany
Research Site
Dusseldorf, Germany
Research Site
Beirut, Lebanon
Research Site
Beyrouth, Lebanon
Research Site
Kaunas, Lithuania
Research Site
Breda, Netherlands
Research Site
Nieuwegein, Netherlands
Research Site
Rotterdam, Netherlands
Russian Federation
Research Site
Dnipropetrovsk, Russian Federation
Research Site
Ekaterinburg, Russian Federation
Research Site
Moscow, Russian Federation
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Novosibirsk, Russian Federation
Research Site
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
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Barcelona, Spain
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Madrid, Spain
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Malaga, Spain
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Stockholm, Sweden
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Basel, Switzerland
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Kharkiv, Ukraine
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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
Study Director: Medical Responsible EMD Serono, an affiliate of Merck KGaA Darmstadt, Germany
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: EMD Serono Identifier: NCT00642902     History of Changes
Other Study ID Numbers: 28063
Study First Received: March 21, 2008
Results First Received: April 15, 2016
Last Updated: April 15, 2016

Keywords provided by EMD Serono:
Relapsing Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases processed this record on August 18, 2017