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Active Clinical Trials

OCRELIZUMAB

Active NCT:
02637856
Allegheny General Hospital
Allegheny General Hospital

Category:
Brain and Nerve
Sponsor: 
Genentech, Inc.
Contact: 

For more information, please contact Vibha Chauhan at 412-359-5075 or Vibha.Chauhang@ahn.org

AN OPEN-LABEL STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH RELAPSING REMITTING MULTIPLE SCLEROSIS WHO HAVE HAD A SUBOPTIMAL RESPONSE TO AN ADEQUATE COURSE OF DISEASE MODIFYING TREATMENT

Purpose: 

This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who have had a suboptimal response to an adequate course of DMT. Participants will receive ocrelizumab as an initial dose of two 300-milligram (mg) intravenous (IV) infusions (600 mg total) separated by 14 days followed by one 600-mg IV infusion every 24 weeks for the study duration. Anticipated time on study treatment is 96 weeks.

Inclusion Criteria:

  • Diagnosis of multiple sclerosis (specifically RRMS), in accordance with the revised 2010 McDonald criteria
  • Disease duration from first symptom of less than or equal to (</=) 12 years
  • Treated with an adequate course of treatment with no more than three prior DMT regimens of greater than or equal to (>/=) 6 months, and the discontinuation of the most recent adequately used DMT was due to suboptimal response
  • Suboptimal response while the participant was on his/her last adequately used DMT for >/=6 months (defined by having one of the following qualifying events despite being on a stable dose of the same DMT for at least 6 months: one or more clinically reported relapses, one or more T1 Gd-enhanced lesions, or two or more new or enlarging T2 lesions on MRI); these qualifying events must have occurred while on the last adequately used DMT. In participants receiving stable doses of the same approved DMT for more than a year, the event must have occurred within the last 12 months of treatment with this DMT from the date of screening

 

Exclusion Criteria:

  • History of primary progressive multiple sclerosis (PPMS), progressive relapsing multiple sclerosis (PRMS), or secondary progressive multiple sclerosis (SPMS)
  • Contraindications for MRI
  • Known presence of other neurological disorders that may mimic multiple sclerosis
  • Pregnancy or lactation
  • Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
  • History of or currently active primary or secondary immunodeficiency
  • Lack of peripheral venous access
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  • Active infection, or history of or known presence of recurrent or chronic infection such as human immunodeficiency virus (HIV), syphilis, or tuberculosis
  • History of progressive multifocal leukoencephalopathy
  • Contraindications to or intolerance of oral or IV corticosteroids
  • Previous treatment with fingolimod (Gilenya®) or dimethyl fumarate (Tecfidera®) in participants whose lymphocyte count is below the lower limit of normal (LLN)
  • Treatment with alemtuzumab (Lemtrada®)
  • Previous treatment with systemic cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine, or methotrexate
  • Previous treatment with natalizumab within 12 months prior to screening unless failure was due to confirmed, persistent anti-drug antibodies (ADAs). Participants previously treated with natalizumab will be eligible for this study only if duration of treatment with natalizumab was less than (<) 1 year and natalizumab was not used in the 12 months prior to screening. Anti-John Cunningham virus (JCV) antibody status (positive or negative) and titer (both assessed within the year of screening) must be documented prior to enrollment
  • Treatment with dalfampridine (Ampyra®) unless on stable dose for >/=30 days prior to screening
  • Treatment with a B-cell targeted therapies (e.g., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
  • Treatment with a drug that is experimental (Exception: treatment with an experimental drug that was subsequently approved in the participant's country is allowed)