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Status:

TERMINATED

Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis

Lead Sponsor:

Genzyme, a Sanofi Company

Conditions:

Relapsing-remitting Multiple Sclerosis

Eligibility:

All Genders

18-55 years

Phase:

PHASE2

Brief Summary

Primary Objectives: * To assess the efficacy of vatelizumab compared to placebo as measured by a reduction in new contrast-enhancing lesions (CELs) in relapsing remitting multiple sclerosis (RRMS) pa...

Detailed Description

The duration of study per patient will be up to 108 weeks, including a screening period of up to 4 weeks, a treatment period of 12 weeks and a post-treatment safety follow-up period of up to 92 weeks....

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Diagnosis of relapsing-remitting multiple sclerosis (RRMS). At least 1 documented relapse in the past 12 months. At least 1 contrast-enhancing lesion (CEL) on magnetic resonance imaging (MRI) in the past 12 months and/or at screening.
  • At least 3 T2 lesions on screening MRI.
  • Exclusion criteria:
  • Diagnosis of primary progressive or secondary progressive MS. Expanded disability status scale (EDSS) score \>5.5. Relapse within 30 days prior to enrollment. Prior immunosuppressive treatment within protocol-specified time periods. Prior treatment with natalizumab (Tysabri®). History of bleeding/platelet disorders, malignancy, certain infections as defined in the protocol, or any other past or current medical conditions that would adversely affect the patient's participation in the study.
  • Pregnancy or breast-feeding. Other protocol-defined inclusion/exclusion criteria may apply.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Exclusion

    Key Trial Info

    Start Date :

    September 1 2014

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2016

    Estimated Enrollment :

    112 Patients enrolled

    Trial Details

    Trial ID

    NCT02222948

    Start Date

    September 1 2014

    End Date

    July 1 2016

    Last Update

    December 21 2016

    Active Locations (32)

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    Page 1 of 8 (32 locations)

    1

    Investigational Site Number 840004

    Cullman, Alabama, United States, 35058

    2

    Investigational Site Number 840009

    Phoenix, Arizona, United States, 85060

    3

    Investigational Site Number 840005

    Fort Collins, Colorado, United States, 80528

    4

    Investigational Site Number 840014

    Washington D.C., District of Columbia, United States, 20037