For decades, Black and Hispanic Americans have been underrepresented in multiple sclerosis (MS) clinical trials examining new drugs. The CHIMES (Characterization of Ocrelizumab in Minorities With Multiple Sclerosis) trial was developed in order to address and better understand this issue.
Its novel trial design was presented at the recent Consortium of Multiple Sclerosis Centers (CMSC) meeting by Mitzi J. Williams, MD, medical director of the Joi Life Wellness Group in Smyrna, Georgia. It will include approximately 150 self-identified Black or African American and Hispanic/Latino patients with relapsing MS receiving treatment with ocrelizumab (Ocrevus).
In this exclusive MedPage Today video, Williams describes this unique study.
Following is a transcript of her remarks:
I’m very excited to talk about the CHIMES study, our first presentation at the Consortium of Multiple Sclerosis Centers meeting this year in Orlando, and it’s a very unique study in that it focuses on African American and Hispanic American patients with multiple sclerosis. So it is the first clinical trial that is focused on this population primarily.
The reason there’s really a need for studying this population or these populations, is because there is a wealth of data that suggests that MS disease activity is worse in Black patients and Hispanic Latino patients, especially for Black patients. There is more MRI disability and there is more walking disability up to six years earlier than their white counterparts. But there’s not really a lot of data to help us to understand why we see these differences because there’s very low enrollment of both of these groups in our clinical trials.
The focus of the presentation was really to talk about the study design which was very unique so we have not reported any of the results yet, but we have completed enrollment ahead of schedule, and actually over-enrolled the study, which is very exciting.
So we talked about the study design in hopes that it would help to give tips or ideas to others who are trying to recruit these populations into their clinical studies. What we did was we looked at some of the criteria because we recognized that low enrollment at clinical trials is not just because of patient lack of participation, but that there are also systemic barriers that can interfere with enrollment. So what we did was try to look at some of those barriers and remove some of them, so that we could have good, adequate enrollment for this study.
So we looked at inclusion criteria, including things like kidney function, as well as hemoglobin A1C. We know that these populations tend to have higher percentages of comorbidities, and so we basically loosened some of that criteria, not so much as to interfere with results, but so that we could allow for more enrollment of these populations.
We also made sure that all of our materials were appropriately translated into Spanish for our Spanish-speaking patients so that they can understand, or the family members could understand — as many times family members are involved in the decision making process.
And then we also looked at the centers where we were doing recruiting. One of the other major issues with a clinical trial enrollment is that many of the centers where the research is being done are not centers that have very diverse populations. And so we made sure that we try to focus on centers where there were diverse groups of patients so that they could be enrolled in the study.
And essentially the design was very similar to the OBOE study, which is a study done with Ocrevus [ocrelizumab]. We’re looking at an Ocrevus open-label phase IV extension study where we’re looking at these two arms of patients, and we’re looking at some of our traditional measures, such as MRI gadolinium enhancing lesions, as well as T2 lesions. We’re also looking at annualized relapse rate. But we are also looking at other markers such as NfL (neurofilament light chain), such as ancestry markers, genetic markers to try to see if we can understand if there is some underlying biologic base for some of the differences that we see and outcomes in these populations as well.