4 Year Ocrelizumab Study

Everyday living
1

I was surprised when my neurologist suggested I think about joining the 4 year study for the new drug Ocrelizumab. I have been on Plegridy for a year and although I haven’t had any relapses, my last MRI showed a new lesion in my spinal cord. I’m due for the screening for the study this coming Friday. I know there will be 76 people on the study in the UK and I was wondering if anyone else has been considering it or has already been accepted on to the study?

Thanks

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Climbroxx, can you tell me more about this study as it’s something I would consider too.

Have the 76 already been recruited or are they still looking for volunteers? Are you RRMS?

Are the volunteers all in a certain region of the county - I’m in West Midlands

I’m on Plegridy too, since Feb 16.

I had an MRI with contract at the end of Jan but won’t see the neuro till May, so I assume I won’t know my results till then - neuro doesn’t think I’ve had a relapse, he ordered MRI as he thinks my MS is active, although I’m not sure what the difference is. he implied he would look at changing my DMD depending on what the MRI showed.

Ang C

3

Hi AngC,

I do have RRMS and yes I would imagine they are still recruiting for the study.

Here is the link to the study info and what locations are going to be recruiting - A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT) - Full Text View - ClinicalTrials.gov

It would seem it’s at hospitals all over the UK so it’s worth asking your Neurologist/MS Nurse about it as I didn’t expect my neuro to offer it to me at all.

The acceptance criteria states:

Ages Eligible for Study: 18 Years to 55 Years (Adult)Sexes Eligible for Study: All Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

  • Have a definite diagnosis of RRMS, confirmed as per the revised McDonald 2010 criteria
  • Have a length of disease duration, from first symptom, of less than (<) 10 years
  • Have received no more than two prior DMTs, and the discontinuation of the most recent DMT was due to lack of efficacy
  • Suboptimal disease control while on a DMT
  • Expanded Disability Status Scale (EDSS) of 0.0 to 4.0, inclusive, at Screening
  • For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 6 months after the last dose of study drug

Exclusion Criteria:

  • Secondary progressive multiple sclerosis (SPMS) or history of primary progressive or progressive relapsing multiple sclerosis (MS)
  • Inability to complete an Magnetic Resonance Imaging (MRI) procedure
  • Known presence of other neurological disorders
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
  • History or currently active primary or secondary immunodeficiency
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  • History of opportunistic infections
  • History or known presence of recurrent or chronic infection
  • History of malignancy
  • Congestive heart failure
  • Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds

I will know more after the screening on Friday but I hope this helps.

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Thank you, I fell at the first hurdle, I’m 59 :frowning:

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Oh no… according to my neuro the drug should be licenced in 18 months to 2 years all being well.

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I’ve just looked at the link you added, my hospital is in the list where recruitment is yet to start and the exclusions don’t actually say ‘no over 55’s’ so I will speak to my neuro (next appointment is May) and see what he says. Thank you again for the info.

I think I’m probably just clutching at straws.

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It’s got to be worth a try… good luck