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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00642902




Registration number
NCT00642902
Ethics application status
Date submitted
21/03/2008
Date registered
25/03/2008
Date last updated
24/05/2016

Titles & IDs
Public title
A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)
Scientific 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
Secondary ID [1] 0 0
28063
Universal Trial Number (UTN)
Trial acronym
ATAMS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atacicept
Treatment: Drugs - Atacicept
Treatment: Drugs - Atacicept
Treatment: Drugs - Placebo matched to atacicept

Experimental: Atacicept 25 mg -

Experimental: Atacicept 75 mg -

Experimental: Atacicept 150 mg -

Placebo Comparator: Placebo -


Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.

Treatment: Drugs: 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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
Weeks 12 to 36
Secondary outcome [1] 0 0
Number of New T1 Gd-enhancing Lesions Per Participant - Analysis of new T1 Gd-enhancing lesions was done using MRI scans.
Timepoint [1] 0 0
Weeks 12, 24, 36
Secondary outcome [2] 0 0
Percentage of Participants Free From Relapses - 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.
Timepoint [2] 0 0
Baseline up to Week 36
Secondary outcome [3] 0 0
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs - 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.
Timepoint [3] 0 0
From the first dose of study drug administration up to 12 weeks after the last dose of the study drug

Eligibility
Key inclusion criteria
- Diagnosis of RMS (as per McDonald criteria, 2005) Other protocol-defined inclusion
criteria could apply.
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Box Hill
Recruitment hospital [2] 0 0
Research Site - Fitzroy
Recruitment hospital [3] 0 0
Research Site - New Lambton
Recruitment hospital [4] 0 0
Research Site - Woodville
Recruitment postcode(s) [1] 0 0
- Box Hill
Recruitment postcode(s) [2] 0 0
- Fitzroy
Recruitment postcode(s) [3] 0 0
- New Lambton
Recruitment postcode(s) [4] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
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Michigan
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United States of America
State/province [5] 0 0
New Hampshire
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United States of America
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Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Tennessee
Country [9] 0 0
Austria
State/province [9] 0 0
Innsbruck
Country [10] 0 0
Belgium
State/province [10] 0 0
Diepenbeek
Country [11] 0 0
Belgium
State/province [11] 0 0
Sijsele
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Czech Republic
State/province [14] 0 0
Brno
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Hradec Kralove
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Olomouc
Country [17] 0 0
France
State/province [17] 0 0
Caen
Country [18] 0 0
France
State/province [18] 0 0
Saint-Herblain
Country [19] 0 0
Germany
State/province [19] 0 0
Bochum
Country [20] 0 0
Germany
State/province [20] 0 0
Dusseldorf
Country [21] 0 0
Lebanon
State/province [21] 0 0
Beirut
Country [22] 0 0
Lebanon
State/province [22] 0 0
Beyrouth
Country [23] 0 0
Lithuania
State/province [23] 0 0
Kaunas
Country [24] 0 0
Netherlands
State/province [24] 0 0
Breda
Country [25] 0 0
Netherlands
State/province [25] 0 0
Nieuwegein
Country [26] 0 0
Netherlands
State/province [26] 0 0
Rotterdam
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Dnipropetrovsk
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Ekaterinburg
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Moscow
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Novosibirsk
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Saint Petersburg
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Samara
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Vladimir
Country [34] 0 0
Russian Federation
State/province [34] 0 0
Yaroslavl
Country [35] 0 0
Spain
State/province [35] 0 0
Barcelona
Country [36] 0 0
Spain
State/province [36] 0 0
Madrid
Country [37] 0 0
Spain
State/province [37] 0 0
Malaga
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Sweden
State/province [38] 0 0
Stockholm
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Switzerland
State/province [39] 0 0
Basel
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Ukraine
State/province [40] 0 0
Kharkiv
Country [41] 0 0
Ukraine
State/province [41] 0 0
Kyiv
Country [42] 0 0
Ukraine
State/province [42] 0 0
Odessa
Country [43] 0 0
Ukraine
State/province [43] 0 0
Uzhgorod
Country [44] 0 0
United Kingdom
State/province [44] 0 0
London
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Sheffield
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Stoke on Trent

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
EMD Serono
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00642902
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Responsible
Address 0 0
EMD Serono, an affiliate of Merck KGaA Darmstadt, Germany
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00642902