New MS study focuses on minority populations


For decades, black and Hispanic Americans have been under-represented in multiple sclerosis (MS) clinical trials examining new drugs. The CHIMES trial (Characterization of Ocrelizumab in Minorities With Multiple Sclerosis) was developed in order to address and better understand this problem.

His new trial design has been presented at the recent meeting of the Multiple Sclerosis Centers Consortium (CMSC) through 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 recurrent MS receiving treatment with ocrelizumab (Ocrevus).

In this exclusivity MedPage today video, williams describes this unique study.

Here is a transcript of his remarks:

I’m very happy to talk about the CHIMES study, our first presentation at this year’s Consortium of Multiple Sclerosis Centers meeting in Orlando, and it’s a very unique study in that it focuses on patients. African Americans and Hispanics with multiple sclerosis. It is therefore the first clinical trial to focus mainly on this population.

The reason why there is really a need to study this population or populations is because there is a plethora of data that suggests that MS activity is worse in black patients and Hispanic Latino patients, especially for black patients. There are more MRI disabilities and there are more walking disabilities up to six years earlier than their white counterparts. But there isn’t really a lot of data to help us understand why we are seeing these differences, as there is very little recruitment from these two groups in our clinical trials.

The purpose of the presentation was really to talk about the study design which was quite unique, so we haven’t reported the results yet, but we completed the recruitment earlier than expected and in fact over-enlisted the study, which is very exciting.

So we talked about the study design in the hope that it would help give some advice or ideas to others trying to recruit these populations into their clinical studies. What we did was we looked at some of the criteria because we recognized that the low enrollment in clinical trials is not only due to the lack of patient participation, but that there are systemic barriers as well. that can interfere with recruiting. So we have tried to look at some of these barriers and remove some of them, so that we can have a good number of adequate registrations for this study.

We therefore examined the inclusion criteria, in particular renal function, as well as hemoglobin A1C. We know these populations tend to have higher percentages of co-morbidities, so we’ve basically relaxed some of these criteria, not so much to interfere with the outcome, but to allow for greater recruitment of these populations.

We also made sure that all of our documents were appropriately translated into Spanish for our Spanish speaking patients so that they can understand, or family members can understand – as many times as family members are involved in the process. decision making process.

And then we also looked at the centers where we were recruiting. One of the other major issues with enrolling in a clinical trial is that many of the centers where research is done are not centers that have very diverse populations. So we made sure to try to focus on the centers where there were various groups of patients so that they could be included in the study.

And essentially, the design was very similar to the Oboe study, which is a study carried out with Ocrevus [ocrelizumab]. We are reviewing an open-label Phase IV extension study of Ocrevus in which we are looking at these two groups of patients, and we are looking at some of our traditional measures, such as MRI of gadolinium-enhancing lesions, as well as T2 lesions. . . We also look at the 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 an underlying biological basis for some of the differences we see and results in these populations too.

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