Study Stopped
Sponsor voluntarily decided to terminate trial due to increased MS disease activity in atacicept arms as compared to placebo during a routine IDMC review.
A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)
ATAMS
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
1 other identifier
interventional
255
16 countries
46
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2008
Shorter than P25 for phase_2
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2008
CompletedFirst Posted
Study publicly available on registry
March 25, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
May 24, 2016
CompletedMay 24, 2016
April 1, 2016
1.4 years
March 21, 2008
April 15, 2016
April 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan
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).
Weeks 12 to 36
Secondary Outcomes (3)
Number of New T1 Gd-enhancing Lesions Per Participant
Weeks 12, 24, 36
Percentage of Participants Free From Relapses
Baseline up to Week 36
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
Study Arms (4)
Atacicept 25 mg
EXPERIMENTALAtacicept 75 mg
EXPERIMENTALAtacicept 150 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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.
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 Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EMD Seronolead
Study Sites (50)
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
Unknown Facility
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
Research Site
Beirut, Lebanon
Research Site
Kaunas, Lithuania
Research Site
Breda, Netherlands
Research Site
Nieuwegein, Netherlands
Research Site
Rotterdam, Netherlands
Research Site
Dnipropetrovsk, Russia
Research Site
Moscow, Russia
Research Site
Novosibirsk, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Vladimir, Russia
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Yaroslavl, Russia
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Yekaterinburg, Russia
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Barcelona, Spain
Research Site
Madrid, Spain
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Málaga, Spain
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Stockholm, Sweden
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Basel, Switzerland
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Kharkiv, Ukraine
Research Site
Kyiv, Ukraine
Research Site
Odesa, Ukraine
Research Site
Uzhhorod, Ukraine
Research Site
London, United Kingdom
Research Site
Sheffield, United Kingdom
Research Site
Stoke-on-Trent, United Kingdom
Related Publications (1)
Kappos L, Hartung HP, Freedman MS, Boyko A, Radu EW, Mikol DD, Lamarine M, Hyvert Y, Freudensprung U, Plitz T, van Beek J; ATAMS Study Group. Atacicept in multiple sclerosis (ATAMS): a randomised, placebo-controlled, double-blind, phase 2 trial. Lancet Neurol. 2014 Apr;13(4):353-63. doi: 10.1016/S1474-4422(14)70028-6. Epub 2014 Mar 6.
PMID: 24613349DERIVED
Related Links
MeSH Terms
Interventions
Limitations and Caveats
Sponsor voluntarily decided to prematurely terminate this trial due to an increase in multiple sclerosis (MS) disease activity observed in atacicept arms as compared to placebo during a routine independent data monitoring committee (IDMC) review.
Results Point of Contact
- Title
- Merck KGaA Communication Center
- Organization
- Merck Serono, a division of Merck KGaA
Study Officials
- STUDY DIRECTOR
Medical Responsible
EMD Serono, an affiliate of Merck KGaA Darmstadt, Germany
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2008
First Posted
March 25, 2008
Study Start
April 1, 2008
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
May 24, 2016
Results First Posted
May 24, 2016
Record last verified: 2016-04