Center for Global Research Data

Comorbidity and Clinical Trials of Disease-Modifying Therapies in Multiple Sclerosis

Lead Investigator: Amber Salter, University of Texas Southwestern Medical Center
Title of Proposal Research: Comorbidity and Clinical Trials of Disease-Modifying Therapies in Multiple Sclerosis
Vivli Data Request: 7606
Funding Source: Department of Defense
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Multiple sclerosis (MS) is a chronic disease where the immune system attacks the brain and spinal cord. It is estimated that 2.8 million people live with MS worldwide. People living with MS often have co-existing (comorbid) health conditions. Examples include depression, anxiety and high blood pressure. Prior studies suggested that these co-existing conditions may affect the severity of MS. For example, relapses may occur more often, and disability may worsen more quickly. However, findings from these studies have differed. We recently got data from a clinical trial comparing two MS treatments, the CombiRx trial. We used these data to see if we could use clinical trial data to look at how co-existing health conditions affect disease activity in MS. We found that the clinical trial worked very well to answer this question. Also, we found that high cholesterol and anxiety were associated with an increased risk of relapse. In this study we will look at data from multiple, completed clinical trials to look at how co-existing health conditions affect disease activity and progression in MS. By using consistent methods and combining the results across studies we can much more confident about our findings.

The study will use existing data collected from multiple clinical trials designed to test how well disease-modifying therapies (DMT) work in MS. In clinical trials, data are collected carefully, at regular intervals, and in large numbers of people. We will use these data to find out if co-existing conditions affect how likely it is for someone with MS to have a relapse, develop worsening disability or new lesions on brain magnetic resonance imaging (MRI), all considered measures of disease activity. We will also use these data to find out if having a comorbid condition affects how well a DMT therapy works. For example, does having diabetes in addition to MS make a DMT work less well? We hope that this information will help people with MS and their clinicians make more informed and personalized decisions about treatment.

The information gained from this study has the potential to greatly advance MS care. Our findings will provide a better understanding of the effect of specific comorbid conditions on disease activity, and how well DMTs work in MS persons with these conditions. When we finish this study, this information could help clinicians and people with relapsing MS to make better decisions about their care by helping them to consider all of their health conditions in their decisions. The study will raise awareness and encourage clinicians to take a more holistic approach to treating MS and these other conditions.

Requested Studies:

A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif®) in Patients With Relapsing Multiple Sclerosis
Data Contributor: Roche
Study ID: NCT01247324
Sponsor ID: WA21092

A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis
Data Contributor: Roche
Study ID: NCT01412333
Sponsor ID: WA21093

A Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis
Data Contributor: Roche
Study ID: NCT01194570
Sponsor ID: WA25046