Exploring Diroximel Fumarate Real-world Experience in Canada and Israel

NCT04948606 | Terminated FDA Drug

• 1 other identifier: CA-VUM-11892
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 6

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); to assess the impact of DRF on disability; to assess treatment satisfaction with DRF; to explore the real-world safety profile of DRF (i.e., 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

  Year 1

Secondary Outcomes (16)

• Percentage of Participants on Treatment with DRF

  Month 3

• Percentage of Participants on Treatment with DRF

  Year 2

• Annualized Relapse Rate (ARR) with DRF

  Year 1 and 2

• Percentage of Participants Relapsed

  Year 1 and 2

• Change in Cognitive Processing Speed Test (CPST) Score

  Baseline, Year 1 and 2

Study Arms (1)

Diroximel Fumarate (DRF)

Participants with a confirmed diagnosis of MS who are newly prescribed DRF in routine clinical practice and who satisfy the approved therapeutic indication for DRF will be enrolled.

Drug: Diroximel Fumarate

Interventions

Diroximel Fumarate DRUG

Administered as specified in the treatment arm.

Also known as: VUMERITY, BIIB098

Diroximel Fumarate (DRF)

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 RMS that have been prescribed DRF under standard clinical care.

You may qualify if:

• Have a diagnosis of MS and satisfy the approved therapeutic indication for DRF per the prescribing information.
• DRF prescribed and planned to be initiated within 60 days of enrollment or already initiated, with enrollment occurring no more than 7 days since the first dose.

You may not qualify if:

• History of gastric bypass or required use of feeding tubes.
• Current enrollment in any interventional study or in any study which may conflict with this study, per the discretion of the principal investigator (PI) and Biogen
• Have received prior treatment with DRF (more than 7 days before enrollment).

Sponsors & Collaborators

• Biogen: lead

Study Sites (6)

Lady Davis Carmel Medical Center

Haifa, Israel

Location

Hadassah Medical Center

Jerusalem, Israel

Location

Meir Medical Center

Kfar Saba, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Tel Aviv Sourasky Medical

Tel Aviv, Israel

Location

Sheba Medical Center

Tel Litwinsky, Israel

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: June 28, 2021
• First Posted: July 2, 2021
• Study Start: December 9, 2021
• Primary Completion: April 14, 2023
• Study Completion: April 14, 2023
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

IL (6)