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

March 21, 2008
April 15, 2016
April 2008
September 2009   (final data collection date for primary outcome measure)
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).
Mean number of T1 gadolinium (Gd)-enhancing lesions per subject per scan. [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00642902 on ClinicalTrials.gov Archive Site
  • 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.
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 [ Time Frame: Weeks 12, 24, 36 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Relapsing Multiple Sclerosis
  • 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.
  • 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.
  • 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.
  • 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.
  • Experimental: Atacicept 25 mg
    Intervention: Drug: Atacicept
  • Experimental: Atacicept 75 mg
    Intervention: Drug: Atacicept
  • Experimental: Atacicept 150 mg
    Intervention: Drug: Atacicept
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo matched to atacicept
Kappos L, Hartung HP, Freedman MS, Boyko A, Radü 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
255
September 2009
September 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   Czech Republic,   France,   Germany,   Lebanon,   Lithuania,   Netherlands,   Russian Federation,   Spain,   Sweden,   Switzerland,   Ukraine,   United Kingdom
 
NCT00642902
28063
Yes
Not Provided
Not Provided
EMD Serono
EMD Serono
Not Provided
Study Director: Medical Responsible EMD Serono, an affiliate of Merck KGaA Darmstadt, Germany
EMD Serono
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP