A clinical trial to evaluate the physical impact of multiple sclerosis and to continue to provide treatments to participants with multiple sclerosis who benefitted from a clinical trial sponsored by Genentech, Inc. and/or F. Hoffmann-La Roche Ltd

1. Why is the OleroMAX clinical trial needed?

This clinical trial aims to evaluate the patient perspective on the physical impact of multiple sclerosis and continue to provide ocrelizumab to people with multiple sclerosis who have taken part in an ocrelizumab trial that is sponsored by Genentech, Inc. and/or F. Hoffmann-La Roche Ltd (called parent trials) and who do not have reasonable access to the treatment locally.

People with multiple sclerosis who experienced some kind of benefit from a treatment with ocrelizumab in a clinical trial may continue to be given ocrelizumab if there is no other treatment option reasonably available and if it is safe to do so. “Reasonably available” means that after the clinical trial has ended, ocrelizumab may not be approved by the health authority (such as the Food and Drug Administration [FDA] in the United States, or the European Medicines Agency [EMA] in the European Union). It might also mean that if ocrelizumab is approved by the relevant health authority, health insurance or other costs might prevent or make it difficult for people to access the treatment.

2. How does the OleroMAX clinical trial work?

This clinical trial is recruiting people with multiple sclerosis. People can take part if they were previously treated with Ocrelizumab in a Genentech, Inc. and/or F. Hoffmann-La Roche Ltd-sponsored clinical trial (the parent trial), and they were shown to benefit from ocrelizumab.

People who take part in this clinical trial (participants) will be given the same clinical trial treatment (ocrelizumab) as in the parent trial for as long as it can help them, or until they have unacceptable side effects or the trial stops. This allows people that benefit from ocrelizumab to continue taking ocrelizumab, which is otherwise not reasonably available to them. The clinical trial team will see them regularly. During these hospital visits, doctors will check how Multiple Sclerosis is affecting the participant`s body, see how well the treatment is working, and check for any side effects. The total time of participation in the clinical trial will depend on whether ocrelizumab is safe and continues to work for the patient, the local availability of ocrelizumab and if the trial is stopped. Participants can stop ocrelizumab treatment and leave the clinical trial at any time.

3. What are the main endpoints of the OleroMAX clinical trial?

This trial will evaluate the patient perspective of the physical impact of Multiple Sclerosis and the number of participants who have received access to ocrelizumab. The clinical trial team will continue to monitor the safety of ocrelizumab treatment by checking the number and type of serious side effects.

4. Who can take part in this clinical trial?

People can take part in this trial if they have multiple sclerosis and they benefited from the ocrelizumab treatment given in the parent trial. People should also have not experienced side effects that were serious or could not be managed or tolerated.

People may not be able to take part in this trial if they have been given certain other neurological treatments since completing the parent trial. People will also not be able to take part if ocrelizumab becomes reasonably available to them through routine healthcare outside of a clinical trial, or if they are pregnant , or are planning to become pregnant during the trial. There may be a possibility to re-enter the trial after pregnancy.

5. What treatment will participants be given in this clinical trial?

Everyone who joins this clinical trial will continue to be given ocrelizumab as they received previously in a Genentech, Inc. and/or F. Hoffmann-La Roche Ltd-sponsored parent clinical trial with ocrelizumab. As ocrelizumab is available in different formulations or can be given in different ways (e.g. injection or infusion) the clinical trial doctor may suggest the best option for the participant. This is an open-label trial, which means everyone involved, including the participant and the clinical trial doctor, will know the clinical trial treatment the participant has been given.

6. Are there any risks or benefits in taking part in this clinical trial?

The safety and effectiveness of ocrelizumab is well documented through 11 years of clinical trials and broad real world data. Nevertheless, most trials involve some risks to the participant. However, it may not be greater than the risks related to routine medical care or the natural progression of the health condition. People who would like to participate will be told about any risks and benefits of taking part in the clinical trial, as well as any additional procedures, tests or assessments they will be asked to undergo. All of these will be described in an informed consent document (a document that provides people with the information they need to decide to volunteer for the clinical trial).

Risks associated with the clinical trial treatments
Participants may have side effects (an unwanted effect of a drug or medical treatment) from the ocrelizumab treatment used in this clinical trial. Side effects can be mild to severe, even life-threatening and vary from person to person. Participants will be closely monitored during the clinical trial; safety assessments will be performed regularly.

Participants will be told about the known side effects of ocrelizumab and possible side effects based on human and laboratory studies or knowledge of similar drugs. Participants will be told about any known side effects of how the treatment will be given, for example, injections under the skin (subcutaneous injections) or, infusions into a vein (intravenous infusions).

Potential benefits associated with the clinical trial
Participants' health may or may not improve from participation in the clinical trial. Still, the information collected may help other people with similar medical conditions in the future.