How does the OPERETTA 1 clinical trial work?
This clinical trial is recruiting children and young people who have a type of disease called relapsing-remitting multiple sclerosis (RRMS).

The purpose of this clinical trial is to test the safety of ocrelizumab at certain doses and to understand the way your body processes ocrelizumab. It will also identify the dose of ocrelizumab that is most appropriate to use for children and adolescents in further trials.

How do I take part in this clinical trial?
To be able to take part in this clinical trial, you must have a diagnosis of RRMS, be aged 10 to 17 years, and have a body weight of at least 25 kg.

You must not have received previous B-cell targeted therapy. If you have certain other medical conditions or have received certain other medications, you may not be able to take part in this clinical trial.

If you think this clinical trial may be suitable for you (or your child) and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, they may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.

You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial.

Before starting the clinical trial, you will be told about the risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part.

While taking part in the clinical trial, if you are not currently pregnant but can become pregnant, you will need to either not have heterosexual intercourse or take contraceptive medication for safety reasons. 

What treatment will I be given if I join this clinical trial?

Everyone who joins this clinical trial will enter a 2-month screening period to check that they are suitable to enter the clinical trial.  All suitable patients will then be split into two groups depending on their body weight:

• Group 1: patients who weigh between 25 and 39 kg will be given 300 mg ocrelizumab. This will be given as two separate 150 mg infusions (drug given into your vein) at least two weeks apart. You will only be given these two infusions as the treatment will last for six months.
• Group 2: patients who weigh at least 40 kg will be given 600 mg ocrelizumab. This will be given as two separate 300 mg infusions (drug given into your vein) at least two weeks apart. You will only be given these two infusions as the treatment will last for six months.

Patients in both groups will be monitored over six months to check how the medicine is affecting the body and to check side effects. During this time, you will have to visit the hospital every month to have blood tests.

If you complete the first six months of treatment, you can choose to continue treatment over roughly three years with additional doses of ocrelizumab given as single infusions every six months (using the same dose you received in the first part of the trial until a preferred final dose is selected by the clinical trial team).

How often will I be seen in follow-up appointments and for how long?

You will be given the ocrelizumab treatment as described above, depending on your weight. If you choose to receive the additional doses, you will continue into the 3-year extension period of the trial. You are free to stop this treatment at any time. During treatment, you will be seen regularly by the clinical trial doctor. Hospital visits will include tests (such as blood tests and MRI scans) and checks to see how you are responding to the treatment and any side effects that you may be having.

After stopping treatment, you will still be seen by the clinical trial doctor every three months, and contacted by phone every month, for around 48 weeks (roughly one year). If your B-cell counts are still low after this time, you will continue to be seen by the clinical trial doctor every six months, and contacted by phone every three months, until your B-cell count reaches an acceptable level.

What happens if I am unable to take part in this clinical trial?
If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.

For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04075266

Trial-identifier: NCT04075266