Real World Effectiveness, Persistence, Tolerability, and Safety of Ofatumumab in Clinical Practice

NCT06737419 | Completed

• 1 other identifier: COMB157GUS15
• Study Type: observational
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

This was a retrospective cohort study using the electronic medical record (EMR) database from Cleveland Clinic. The data was analyzed at start of ofatumumab (OMB) therapy (baseline, defined as 6 months prior to OMB initiation) and at 6 or 12 months following initiation of OMB.

Conditions

Multiple Sclerosis

Keywords

Clinically Isolated Syndrome; Relapsing-remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis; Primary Progressive Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Number of Patients Categorized by Number of Relapses

  Baseline, Month 6, Month 12

• Change in Relapse Rate From Baseline to Month 6 and Month 12 After Initiating OMB Treatment

  From Baseline up to Month 6 and Month 12

Secondary Outcomes (22)

• Age

  Baseline

• Number of Patients per Demographic Category

  Baseline

• Mean Duration of Disease

  Baseline

• Number of Patients by Most Recent Disease Course

  Baseline

• Number of Patients by Patient Determined Disease Steps (PDDS) Score

  Baseline, Month 6, Month 12

Study Arms (1)

Ofatumumab Cohort

Adult patients diagnosed with MS who started OMB therapy from the time of approval (August 2020).

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

This was a retrospective, noninterventional cohort study

You may qualify if:

• Patients who initiated OMB commercially from the time of disease modifying therapy (DMT) approval (August 2020), and
• Aged 18 years or older at index date, and
• Patients who met 2017 McDonald Criteria for clinically definite multiple sclerosis (MS), or
• Patients diagnosed with clinically isolated syndrome (CIS) by Cleveland Clinic MS specialist.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: June 9, 2021
• Primary Completion: February 5, 2024
• Study Completion: February 5, 2024
• Last Updated: December 17, 2024

Record last verified: 2024-12

Locations

US (1)