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.)
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT00642902
First received: March 21, 2008
Last updated: April 15, 2016
Last verified: April 2016
  Purpose
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00642902

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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
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Box Hill, Australia
Research Site
Fitzroy, Australia
Research Site
New Lambton, Australia
Research Site
Woodville, Australia
Austria
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Innsbruck, Austria
Belgium
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Diepenbeek, Belgium
Research Site
Sijsele, Belgium
Canada, Alberta
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Calgary, Alberta, Canada
Canada, Ontario
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Ottawa, Ontario, Canada
Canada
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Ontario, Canada
Czech Republic
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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
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Beirut, Lebanon
Research Site
Beyrouth, Lebanon
Lithuania
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Kaunas, Lithuania
Netherlands
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Breda, Netherlands
Research Site
Nieuwegein, Netherlands
Research Site
Rotterdam, Netherlands
Russian Federation
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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
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Stockholm, Sweden
Switzerland
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Basel, Switzerland
Ukraine
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Kharkiv, Ukraine
Research Site
Kyiv, Ukraine
Research Site
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: Medical Responsible EMD Serono, an affiliate of Merck KGaA Darmstadt, Germany
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: EMD Serono
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

Keywords provided by EMD Serono:
Relapsing Multiple Sclerosis
Atacicept

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

ClinicalTrials.gov processed this record on July 21, 2016