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Clinical Trials/EUCTR2014-003265-19-PL
EUCTR2014-003265-19-PL
Active, not recruiting
Phase 1

A Long-Term Follow-up Study Assessing the Safety and Efficacy of Vatelizumab in Multiple Sclerosis (MS) Patients Who Completed Treatment in Study DRI13839

Genzyme Corporation0 sites168 target enrollmentFebruary 26, 2015
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ConditionsRelapsing-remitting multiple sclerosisMedDRA version: 18.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Relapsing-remitting multiple sclerosis
Sponsor
Genzyme Corporation
Enrollment
168
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 26, 2015
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Patients who completed the 12\-week treatment period in DRI13839\.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 168
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •Any clinically significant or ongoing adverse events, or laboratory abnormalities from DRI13839 that per Investigator judgment would adversely affect the patient’s participation in the long\-term extension study.
  • •Confirmed platelet count below the lower limit of normal at any time during DRI13839\.
  • •Pregnancy or breast\-feeding.

Outcomes

Primary Outcomes

Not specified

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