Clinical Trial 45959

Long Beach, CA 90806


Summary:

 

This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks in participants with RMS, in comparison to the approved 600 mg dose of ocrelizumab.



Criteria:
  • Diagnosis of relapsing multiple sclerosis (RMS).
  • At least two documented clinical attacks within the last 2 years prior to screening, or one clinical attack in the year prior to screening. No relapse 30 days prior to screening and at baseline.
  • Participants must be neurologically stable for at least 30 days prior to randomization and baseline.
  • Expanded disability status scale (EDSS), at screening and baseline, from 0 to 5.5 inclusive.
  • Documented MRI of brain with abnormalities consistent with MS prior to screening.
  • Participants requiring symptomatic treatment for MS and/or physiotherapy must be treated at a stable dose. No initiation of symptomatic treatment for MS or physiotherapy within 4 weeks of randomization.
  • For females of childbearing potential, agreement to remain abstinent or use adequate contraceptive methods.
  • For female participants, without reproductive potential may be enrolled if post-menopausal, unless receiving a hormonal therapy for her menopause or if surgically sterile


Qualified Participants May Receive:

Compensation up to $1,440.00 over the study length (27 months).


Available At:

Collaborative Neuroscience Research, LLC

Long Beach, CA 90806
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Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.