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Clinical Trials/EUCTR2011-002333-19-ES
EUCTR2011-002333-19-ES
Active, not recruiting
Phase 1

A Randomized, Double-blind, Placebo controlled, Parallel-Group, Dose-Ranging Study to Investigate the MRI Efficacy and Safety of Six Months? administration of Ofatumumab in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) - Ofatumumab sub-cutaneous in RRMS

GlaxoSmithKline SA0 sites232 target enrollmentSeptember 28, 2011
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DrugsArzerra®

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
GlaxoSmithKline SA
Enrollment
232
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 28, 2011
End Date
June 10, 2015
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Subjects eligible for enrolment in the study must meet all of the following criteria:
  • •1\. Able to provide signed, written informed consent to participate in the study
  • •2\. 18\-55 years of age.
  • •3\. Definite diagnosis of MS according to the 2010 revisions of the McDonald
  • •diagnostic criteria for MS \[Polman, 2011].
  • •4\. Subjects do not have any manifestation of another type of MS other than RRMS.
  • •5\. Subjects must have a relapsing\-remitting course of disease with at least one of the following prior to screening:
  • •A. At least one confirmed relapse within the previous year or
  • •B. At least two confirmed relapses within the previous 2 years or
  • •C. At least one relapse in the previous 2 years, with a GdE brain lesion on an MRI scan in the past year.

Exclusion Criteria

  • •Subjects meeting any of the following criteria are not eligible and cannot enroll in the study:
  • •1\. Unable to undergo MRI scans (e.g. due to pacemaker, severe claustrophobia,hypersensitivity to contrast media, or who lack adequate peripheral venous access).
  • •2\. Any clinically significant brain abnormality other than MS found on MRI.
  • •3\. Neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML) or confirmed PML (see Appendix 4, Section 11\.4, for PML monitoring algorithm).
  • •4\. Subjects whom experience a relapse during the Screening Phase. These subjects may be eligible for re\-screening after consultation with GSK.
  • •5\. History of clinically significant CNS trauma (e.g. traumatic brain injury, cerebral contusion, spinal cord compression) or a history or presence of myelopathy due to spinal cord compression by disk or vertebral disease.
  • •6\. Prior treatment with any of the following:
  • •A. Systemic glucocorticoids or Adrenocorticotrophic hormone (ACTH) within one month prior to screening
  • •B. Receipt of a live vaccine within 6 weeks prior to screening
  • •C. Glatiramer acetate (Copaxone) or IFN\-? (Betaferon, Betaseron, Avonex, or Rebif) within 3 months prior to screening

Outcomes

Primary Outcomes

Not specified

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