Sunday, 6 November 2011

Current Ocrelizumab Trials that are recruiting subjects


Eligibility:

  • Ages Eligible for Study: 18 Years to 55 Years
  • Genders Eligible for Study: Both
  • Accepts Healthy Volunteers: No
Inclusion Criteria:
  • Adult patients, 18-55 years of age
  • Primary Progressive Multiple Sclerosis (according to revised McDonald criteria)
  • Expanded Disability Status Scale (EDSS) 3 to 6.5 points
  • Disease duration from onset of MS symptoms < 15 years if EDSS > 5.0, < 10 years if EDSS >/= 5.0
  • Sexually active male and female patients of reproductive potential must use two methods of contraception throughout the study treatment phase and for 48 weeks after the last dose
Exclusion Criteria:
  • History of relapsing remitting multiple sclerosis, secondary progressive, or progressive relapsing multiple sclerosis at screening
  • Contraindications for Magnetic Resonance Imaging (MRI)
  • Known presence of other neurologic disorders
  • Known active infection or history of or presence of recurrent or chronic infection
  • History of cancer, including solid tumors and hematological malignancies (except for basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the cervix that have been excised and resolved)
  • Previous treatment with B-cell targeted therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
  • Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab, anti-CD4, cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study


Study 2A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis (NCT01412333)

Eligibility:

  • Ages Eligible for Study: 18 Years to 55 Years
  • Genders Eligible for Study: Both
  • Accepts Healthy Volunteers: No
Inclusion Criteria:
  • Adult patients, 18-55 years of age inclusive
  • Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria (2010)
  • At least 2 documented clinical attacks within the last 2 years prior to screening or one clinical attack in the years prior to screening (but not within 30 days prior to screening)
  • Neurologic stability for >/= 30 days prior to both screening and baseline
  • Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive
Exclusion Criteria:
  • Primary progressive multiple sclerosis
  • Disease duration of more than 10 years in patients with EDSS </= 2.0 at screening
  • Contraindications for MRI
  • Known presence of other neurological disorders which 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
  • 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 (e.g. hepatitis B or C, HIV, syphilis, tuberculosis)
  • History of progressive multifocal leukoencephalopathy
  • Contraindications to or intolerance of oral or iv corticosteroids
  • Contraindications to Rebif or incompatibility with Rebif use

Study 3A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis (NCT01247324)

Eligibility:

  • Ages Eligible for Study: 18 Years to 55 Years
  • Genders Eligible for Study: Both
  • Accepts Healthy Volunteers: No
Inclusion Criteria:
  • Adult patients, 18-55 years of age inclusive
  • Diagnosis of multiple sclerosis, in accordance with the revised McDonald criteria (2010)
  • At least 2 documented clinical attacks within the last 2 years prior to screening or one clinical attack in the years prior to screening (but not within 30 days prior to screening)
  • Neurologic stability for >/= 30 days prior to both screening and baseline
  • Expanded Disability Status Scale (EDSS) score 0 to 5.5 inclusive
Exclusion Criteria:
  • Primary progressive multiple sclerosis
  • Disease duration of more than 10 years in patients with EDSS </= 2.0 at screening
  • Contraindications for MRI
  • Known presence of other neurological disorders which 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
  • 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 (e.g. hepatitis B or C, HIV, syphilis, tuberculosis)
  • History of progressive multifocal leukoencephalopathy
  • Contraindications to or intolerance of oral or iv corticosteroids
  • Contraindications to Rebif or incompatibility with Rebif use


"Please note that two registration trials are being done for RRMS and one in PPMS. Two trials are needed for RRMS to make sure that if the results of one trial are positive they are not spurious, i.e. a false positive due to chance. Two trials also allows the sponsor to acquire additional safety data; regulators are particularly keen to have safety data on a large number of subjects."


"Only one PPMS trial is probably needed as this is a relatively uncommon form of MS without a licensed treatment at present; in other words there is an unmet need for a therapy in PPMS. The EMA and FDA are likely to treat PPMS in a similar way to an orphan disease; in other words they will only require one registration trial to license a therapy in PPMS."

CoI: We are a participating site for both the primary progressive and relapsing-remitting trials and I am a member of the steering committee for the PPMS trial.

3 comments:

  1. Good to see these trials, especially one for PPMS.

    ReplyDelete
  2. Is Ocrelizumab a new product? I thought it is perhaps Rituximab with a new name.
    If it is a new product, then it will come dearly so for patients/payers-will it Gavin?

    ReplyDelete
  3. Re: "Is Ocrelizumab a new product? I thought it is perhaps Rituximab with a new name. If it is a new product, then it will come dearly so for patients/payers-will it Gavin?"

    It is an improved version of Rituximab; as far as biologicals (protein-based therapies) go it is considered a new product. No doubt it will cost a lot more.

    ReplyDelete

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