Clinical trial NCT00642902: A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Relapsing Multiple Sclerosis
Keywords: Relapsing Multiple Sclerosis
Atacicept
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2008-03-25
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan
timeFrame: Weeks 12 to 36
Secondary outcomes:
measure: Number of New T1 Gd-enhancing Lesions Per Participant
timeFrame: Weeks 12, 24, 36
measure: Percentage of Participants Free From Relapses
timeFrame: Baseline up to Week 36
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
timeFrame: From the first dose of study drug administration up to 12 weeks after the last dose of the study drug
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Northbrook
country: United States
facility: Research Site
state: Illinois
city: East Lansing
country: United States
facility: Research Site
state: Michigan
city: Dartmouth
country: United States
facility: Research Site
state: New Hampshire
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Box Hill
country: Australia
facility: Research Site
city: Fitzroy
country: Australia
facility: Research Site
city: New Lambton
country: Australia
facility: Research Site
city: Woodville
country: Australia
facility: Research Site
city: Innsbruck
country: Austria
facility: Research Site
city: Diepenbeek
country: Belgium
facility: Research Site
city: Sijsele
country: Belgium
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Ontario
country: Canada
facility: Research Site
city: Brno
country: Czech Republic
facility: Research Site
city: Hradec Kralove
country: Czech Republic
facility: Research Site
city: Olomouc
country: Czech Republic
facility: Research Site
city: Caen
country: France
facility: Research Site
city: Saint-Herblain
country: France
facility: Research Site
city: Bochum
country: Germany
facility: Research Site
city: Dusseldorf
country: Germany
facility: Research Site
city: Beirut
country: Lebanon
facility: Research Site
city: Beyrouth
country: Lebanon
facility: Research Site
city: Kaunas
country: Lithuania
facility: Research Site
city: Breda
country: Netherlands
facility: Research Site
city: Nieuwegein
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Dnipropetrovsk
country: Russian Federation
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Samara
country: Russian Federation
facility: Research Site
city: Vladimir
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Basel
country: Switzerland
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Odessa
country: Ukraine
facility: Research Site
city: Uzhgorod
country: Ukraine
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: Stoke on Trent
country: United Kingdom
facility: Research Site
Study officials:
affiliation: EMD Serono, an affiliate of Merck KGaA Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: 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.