A Phase 2 Study of Atacicept in Subjects With Relapsing Multiple Sclerosis (ATAMS)

Phase 2

Terminated

Conditions: Relapsing Multiple Sclerosis

Interventions: Drug: Atacicept
Drug: Placebo matched to atacicept

Registration Number: NCT00642902

Lead Sponsor: EMD Serono

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 255

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atacicept 75 mg	Atacicept	-
Atacicept 150 mg	Atacicept	-
Atacicept 25 mg	Atacicept	-
Placebo	Placebo matched to atacicept	-

Primary Outcome Measures

Name	Time	Method
Mean Number of Time Constant 1 (T1) Gadolinium (Gd)-Enhancing Lesions Per Participant Per Scan	Weeks 12 to 36	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

Name	Time	Method
Number of New T1 Gd-enhancing Lesions Per Participant	Weeks 12, 24, 36	Analysis of new T1 Gd-enhancing lesions was done using MRI scans.
Percentage of Participants Free From Relapses	Baseline up to Week 36	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	From the first dose of study drug administration up to 12 weeks after the last dose of the study drug	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.