Contributions
Abstract: EP1401
Type: ePoster
Abstract Category: Clinical aspects of MS - Clinical assessment tools
Background: Relapses in people with multiple sclerosis (MS) contribute to long-term disability and often indicate the need to switch disease-modifying therapy. In clinical practice, new symptoms concerning for MS relapses, especially if mild, are under-reported. In phase 3 clinical trials in relapsing MS, relapse is usually the primary outcome and typically requires a documented worsening on neurologic exam. Study participants are asked to notify the research team promptly if new symptoms emerge so that, when indicated, a neurologic exam can be performed to confirm a relapse has occurred. However, under-reporting of symptoms is also common in clinical trials, thus reducing relapse detection. This phenomenon is of concern as it leads to inflation of trial sample sizes, escalating costs and delaying availability of new treatments. New strategies are needed to improve MS relapse detection in clinical trials as well as in routine clinical care.
Objective: In an ongoing clinical trial of vitamin D supplementation as add-on to a standard MS therapy in people with relapsing-remitting MS, participants have routine study visits every 12 weeks. We evaluated the impact having a study coordinator check in with participants (weeks 4, 8, 18, 30, 42, 54, 66, 78, and 90) between these routine study visits on the odds of confirmed MS relapse. Coordinators use a standardized script to ask about and characterize any new symptoms, subsequently providing the information to site principal investigators to assess if an unscheduled relapse visit is warranted.
Results: To date, 127 participants, 83 of whom have completed the trial, were available for analyses. Compared to the two-week period prior to the scheduled check-in, the odds of confirming a relapse in the two weeks afterwards were markedly increased (OR=3.51, 95% CI 1.42, 8.70, p=0.007).
Conclusions: Increased engagement of participants between regularly-scheduled visits may improve detection of examination-confirmed MS relapses in clinical trials. Further work is required to determine if the results are generalizable to the broader population of people with MS and to refine engagement strategies in the clinical trial and routine clinical settings.
Disclosure: K. Zorn, A. Calabresi, S. Cassard, and K. Smith have nothing to disclose.
E. Mowry has an investigator-initiated trial funded by Biogen, is the site PI for trials sponsored by Biogen and Sun Pharma, and receives free study medication for an investigator-initiated trial from Teva Neuroscience.
Abstract: EP1401
Type: ePoster
Abstract Category: Clinical aspects of MS - Clinical assessment tools
Background: Relapses in people with multiple sclerosis (MS) contribute to long-term disability and often indicate the need to switch disease-modifying therapy. In clinical practice, new symptoms concerning for MS relapses, especially if mild, are under-reported. In phase 3 clinical trials in relapsing MS, relapse is usually the primary outcome and typically requires a documented worsening on neurologic exam. Study participants are asked to notify the research team promptly if new symptoms emerge so that, when indicated, a neurologic exam can be performed to confirm a relapse has occurred. However, under-reporting of symptoms is also common in clinical trials, thus reducing relapse detection. This phenomenon is of concern as it leads to inflation of trial sample sizes, escalating costs and delaying availability of new treatments. New strategies are needed to improve MS relapse detection in clinical trials as well as in routine clinical care.
Objective: In an ongoing clinical trial of vitamin D supplementation as add-on to a standard MS therapy in people with relapsing-remitting MS, participants have routine study visits every 12 weeks. We evaluated the impact having a study coordinator check in with participants (weeks 4, 8, 18, 30, 42, 54, 66, 78, and 90) between these routine study visits on the odds of confirmed MS relapse. Coordinators use a standardized script to ask about and characterize any new symptoms, subsequently providing the information to site principal investigators to assess if an unscheduled relapse visit is warranted.
Results: To date, 127 participants, 83 of whom have completed the trial, were available for analyses. Compared to the two-week period prior to the scheduled check-in, the odds of confirming a relapse in the two weeks afterwards were markedly increased (OR=3.51, 95% CI 1.42, 8.70, p=0.007).
Conclusions: Increased engagement of participants between regularly-scheduled visits may improve detection of examination-confirmed MS relapses in clinical trials. Further work is required to determine if the results are generalizable to the broader population of people with MS and to refine engagement strategies in the clinical trial and routine clinical settings.
Disclosure: K. Zorn, A. Calabresi, S. Cassard, and K. Smith have nothing to disclose.
E. Mowry has an investigator-initiated trial funded by Biogen, is the site PI for trials sponsored by Biogen and Sun Pharma, and receives free study medication for an investigator-initiated trial from Teva Neuroscience.