Study of Diroximel Fumarate in the Real-World Setting

NCT04746976 | Terminated FDA Drug

• 1 other identifier: US-VUM-11760
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 18

Brief Summary

The primary objective of the study is to characterize the persistence to therapy in participants with relapsing forms of multiple sclerosis (RMS) treated with diroximel fumarate (DRF) in routine clinical practice. The secondary objectives of the study are to assess short-term persistence to treatment; to assess long-term persistence on treatment; to assess the effect of DRF on relapses; to assess the impact of DRF on cognition; to assess the impact of DRF on participant reported outcomes (PROs) and to explore the real-world safety profile of DRF (ie, gastrointestinal \[GI\] tolerability, lymphocyte dynamics, adverse events \[AEs\] leading to discontinuation, and serious adverse events \[SAEs\]).

Conditions

Relapsing Forms of MS

Keywords

Clinically isolated syndrome; Multiple Sclerosis; Relapsing forms of Multiple Sclerosis; Active secondary progressive disease

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants on Treatment with DRF at 1 Year

  1 year

Secondary Outcomes (15)

• Percentage of Participants on Treatment with DRF at 3 Months

  3 months

• Percentage of Participants on Treatment with DRF at 2 Years

  2 years

• Annualized Relapse Rate (ARR) with DRF

  At 1 and 2 years

• Percentage of Participants Relapsed

  At 1 and 2 years

• Change in Processing Speed Test (PST) Score from Baseline

  Baseline up to 2 years

Study Arms (1)

Diroximel Fumarate

Participants with RMS who are receiving diroximel fumarate orally in routine clinical practice will be enrolled.

Drug: Diroximel Fumarate

Interventions

Diroximel Fumarate DRUG

As described in the arm.

Also known as: VUMERITY, BIIB098

Diroximel Fumarate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants diagnosed with Relapsing forms of multiple sclerosis (RMS) that have been prescribed Diroximel Fumarate under standard clinical care.

You may qualify if:

• Have a diagnosis of MS and satisfy the approved therapeutic indication for DRF per the USPI.
• DRF prescribed and planned to be initiated within 60 days after enrollment.

You may not qualify if:

• History of gastric bypass or required use of feeding tubes.
• Have received prior treatment with DRF.

Sponsors & Collaborators

• Biogen: lead

Study Sites (18)

Regina Berkovich MD Phd Inc

West Hollywood, California, 90048, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Norton Neuroscience Institute

Louisville, Kentucky, 40207, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Glendale Neurological Associates, PC

Farmington, Michigan, 48071, United States

Location

Memorial Healthcare

Owosso, Michigan, 48867, United States

Location

St. Luke's Neurology

Kansas City, Missouri, 64111, United States

Location

CentraState Healthcare System - Linda Cardinale MS Center

Freehold, New Jersey, 07728, United States

Location

MS Center at St Barnabas

Livingston, New Jersey, 07039, United States

Location

Multiple Sclerosis Center JSUMC

Neptune City, New Jersey, 07753, United States

Location

Jacobs School of Medicine and Biomedical Sciences

Buffalo, New York, 14202, United States

Location

Cone Health

Greensboro, North Carolina, 27405, United States

Location

Providence Brain and Spine Institute

Portland, Oregon, 97225, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Hope Neurology

Knoxville, Tennessee, 37922, United States

Location

UTHealth Neurosciences Texas Medical Center II

Houston, Texas, 77030, United States

Location

Riverside Neurology Specialists

Newport News, Virginia, 23601, United States

Location

Providence Medical Research Center

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

diroximel fumarate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: March 1, 2021
• Primary Completion: April 14, 2023
• Study Completion: April 14, 2023
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

US (18)