June 14, 2021 | Advocacy, Treatments, Trials
About 15% of people with MS are diagnosed with Primary Progressive Multiple Sclerosis (PPMS). While more common forms of MS involve a relapse-remit pattern (unpredictable attacks followed by periods of disease inactivity), PPMS is characterised by a slow onset and steadily worsening symptoms.
O-Hand, or Oratorio-Hand, is a clinical trial involving 1000 adults with PPMS globally and Multiple Sclerosis NZ is excited to see 4 trial sites taking part in NZ based out of Waikato, Wellington, Christchurch and Dunedin DHBs.
For more information on Clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT04035005?cond=Multiple+Sclerosis&cntry=NZ&draw=2&rank=4
What is Ocrelizumab and how does it work?
Ocrelizumab is a type of antibody, called a humanised monoclonal antibody. Antibodies are part of your immune system and help protect your body from foreign substances (e.g., bacteria or viruses). Ocrelizumab is thought to work by interfering with your immune system’s attack on myelin. Myelin helps your nerve cells communicate with one another quickly.
Ocrelizumab is thought to reduce the number of B-cells and interfere with your immune system’s attack on the myelin around nerve cells; this helps to preserve nerve signalling. Not all B-cells are targeted by ocrelizumab. The ability of the B-cells to regenerate (i.e., from newly formed lymphoid stem cells) as well as the immunity provided by the B-cells (i.e., plasma cell) are kept throughout treatment.
Current status of Ocrelizumab for PPMS in NZ
At this time, there is no known cure for MS. Healthy diet, exercise and rehabilitation are important to ensure successful MS management. Ocrelizumab is the first, and currently only, treatment approved for PPMS. Ocrelizumab is approved for use in many countries. In NZ, while Ocrelizumab has been approved for use in Relapsing (RMS) and Primary Progressive MS (PPMS), it has only been approved for funding for RMS not PPMS.
At the November 2020 meeting of PHARMAC’s Pharmacology and Therapeutics Advisory Committee (PTAC) further information was reviewed to support the application for funding of Ocrelizumab for Primary Progressive MS. At this meeting PTAC recommended listing with low priority and have requested further advice from the Neurological Subcommittee.
Multiple Sclerosis NZ is pleased to see acknowledgement that there is supporting evidence for the use of Ocrelizumab for those with PPMS and recognising the high unmet health need. However, there is still substantial work to be done to progress the recommendation higher up the priority list.
The minutes have recently been published here (see P10) https://pharmac.govt.nz/assets/ptac-record-2020-11.pdf
What is this study looking to understand?
Previous clinical studies have also shown that ocrelizumab may reduce the rate of progression of upper limb disability in people with PPMS, including those with more advanced disability.
The main purpose of this study is to test the effects of ocrelizumab (OCREVUS®) on upper limb function (hands, arms and shoulders) in people with PPMS, including those with more advanced disability.
Will all participants receive Ocrelizumab?
No. O-Hand is a ‘double-blinded trial’. Participants will be split into two study groups for the duration of the trial which will be randomly assigned to receive either ocrelizumab or placebo.
Both groups will receive treatment by an intravenous (IV) infusion (a needle is inserted into your vein). The chance of receiving ocrelizumab versus the placebo is 50%. Being a ‘double-blinded’, means that neither you nor the study doctor will know which group you are in; however, the study doctor can find out in case of emergency.
What is Placebo?
Placebo is a dummy drug that contains no active ingredients. It is used as a control in the study to help the study team confirm that any changes seen are due to ocrelizumab.
If you are receiving placebo, you may later be eligible for the optional open label extension if you meet the criteria.
How will the Ocrelizumab or Placebo be administered
As this is a ‘double blinded trial’ each study group will receive the same dosing schedule. Ocrelizumab or placebo will be given as an intravenous (IV) infusion (by inserting a needle into your vein). These IV infusions will occur during your study visits approximately every 24 weeks; however, the first dose will be provided as two half infusions 2 weeks apart.
Am I Eligible?
Multiple Sclerosis NZ cannot advise whether you are eligible. You will need to discuss this with your neurologist.
You may be eligible to participate in the O’HAND study if you:
For women who can have children you must:
There are additional criteria you need to meet to participate in the study. There are also criteria that may exclude you from participating in the study. The Study Site will discuss these with you further.
We strongly recommend that if you are able to participate in the study, that you take the time to review the Informed Consent and further information about the study with your study team. This is to ensure that you understand the study and the responsibilities of your participation. This is particularly important for women considering family planning.
We encourage you to ask any questions that you may have about the study and ensure you must sign the Informed Consent Form before any study procedures are performed.
The full informed Participant Information Sheet and Consent Forms (PIS/CFs) are available from your local study sites.
How can I enquire about participating?
If you are interested in participating in the O-Hand Study you should contact your local Study Site:
What if I want to participate but there isn’t a trial site in my area?
If there isn’t a trial site in your region, we recommend contacting your nearest site and enquiring whether they are taking participants from further afield. Your neurologist may be able to enquire on your behalf.
What are the risks and side effects associated with ocrelizumab?
As with most treatments side effects are common and vary in severity and manageability. Side effects can be mild to severe and even life threatening, and they can vary from person to person.
The most common side effects of OCREVUS are infusion-related reactions (IRR). Infusion reactions can be serious, so you’ll be carefully monitored throughout your infusion and for at least one hour afterwards. IRRs can happen for up to 24 hours after a dose of OCREVUS:
For more information about IRRs see: https://www.medsafe.govt.nz/Consumers/CMI/o/Ocrevus.pdf or https://getonwithlife.co.nz/about-ocrevus/potential-side-effects-of-ocrevus/
Ocrevus can also cause;
There have also been reports of a rare, serious brain infection called PML (progressive multifocal leukoencephalopathy) in patients receiving other medicines for MS. PML has not been seen in patients treated with OCREVUS, but has been seen in patients taking similar medicines.
Your Study Site will discuss with you the potential side effects. We recommend discussing the risks and benefits with your health care team.
Are there any costs to participating in this study?
You will not be charged for the study drugs or assessments while you are participating in this study. Additionally, all procedures that are needed for participation in the O’HAND study and are not part of your regular medical care will be provided to you at no charge.
You may be reimbursed for any reasonable travel expenses (e.g., accommodation, taxi/bus/air/train fares) as a result of taking part in this study.
What do I do next?
The O’HAND study teams are currently looking for individuals to join the clinical research study. If you are interested in learning more or if you or someone you know may qualify for this study, please contact the your neurology team for more information.