Home Based Infusions for Ocrelizumab

Phase 4

Recruiting

• Conditions: Multiple Sclerosis
• Interventions: Drug: Ocrelizumab at home

• Registration Number: NCT04650321
• Lead Sponsor: University of Colorado, Denver

Brief Summary

The goal is to assess the safety and effectiveness of home ocrelizumab infusion.

Detailed Description

The safety of home ocrelizumab infusion will be assessed by monitoring for infusion reactions and adverse events, and comparing proportions/rates to existing studies. Patient reported outcomes (PROs) will compare pre to post infusion.

Study Timeline

• Study First Submitted: 2020-11-16
• Study First Submitted QC: 2020-12-01
• Study First Posted: 2020-12-02
• Study Start: 2021-03-01
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-08
• Last Update Posted: 2021-06-10
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Current active patient of Rocky Mountain MS Center at the time of final study consent.
• Between 18-55 years of age at the time of final study consent.
• Diagnosis of primary progressive or relapsing MS as defined by the 2017 McDonald criteria.19
• Has at minimum completed their first 600 mg dose of ocrelizumab.
• Is physically residing in the Denver metro, Fort Collins or Colorado Springs area at the time of final study consent.
• Has a Patient Determined Disease Steps (PDDS) between 0 to 6.5 20
• Can complete patient reported outcomes developed and validated as English written scales.
• Must be able and willing to give meaningful, informed consent via electronic signature prior to participation in the study, in accordance with local and FDA regulatory requirements.
• Whose treating neurologist at the RMMSC feels that continuing ocrelizumab s medically appropriate based on at the time of final study consent.

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Exclusion Criteria

• Not pregnant, intentions to get pregnant or lactating at the time of final study consent and on the day of infusion.
• Has previously not participated in the SaROD trial at the RMMSC site.
• Any of the following abnormal laboratory results as processed by a University of Colorado Hospital laboratory site and deemed clinically inappropriate to proceed with a home infusion by the treating neurologist at RMMSC.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Home infusion of ocrelizumab	Ocrelizumab at home	Patients will receive infusion of ocrelizumab at home, instead of at clinic.

Primary Outcome Measures

Name	Time	Method
Severe infusion reactions	24 hours after infusion	Proportion of patients with infusion reactions greater than or equal to 3 on the National Cancer Institute's Common Terminology
Infusion reactions	24 hours after infusion	Proportion of patients with infusion reactions greater than or equal to 1 on the National Cancer Institute's Common Terminology

Secondary Outcome Measures

Name	Time	Method
Adverse events	2 months	Number of adverse events
Severe infusion reactions compared to historic controls.	24 hours after infusion	Difference in proportion of patients with infusion reactions greater than or equal to 3 on the National Cancer Institute's Common Terminology between home infusion and the CHORDS and ENSEMBLE historical controls.
Infusion reactions compared to historic controls.	24 hours after infusion	Difference in proportion of patients with infusion reactions greater than or equal to 1 on the National Cancer Institute's Common Terminology between home infusion and the CHORDS and ENSEMBLE historical controls.
Validated Patient Reported Outcomes (PROs) - PROMIS 10 Physical	2 months	Change in PROMIS 10 values between pre and post infusion. Ranges from 10 to 50. Higher numbers indicate better well being.
Validated Patient Reported Outcomes (PROs) - PROMIS 10 Mental	2 months	Change in PROMIS 10 values between pre and post infusion. Ranges from 10 to 50. Higher numbers indicate better well being.
Validated Patient Reported Outcomes (PROs) - Neuro-QOL Anxiety	2 months	Change in Neuro-QOL Anxiety values between pre and post infusion. Score is transformed to a T score, with population mean of 50 and population standard deviation of 10. T score can range from 36.4 to 76.8. Higher scores mean more anxiety, and hence worse.
Validated Patient Reported Outcomes (PROs) - Neuro-QOL Depression	2 months	Change in Neuro-QOL Depression values between pre and post infusion. Score is transformed to a T score, with population mean of 50 and population standard deviation of 10. T score can range from 36.9 to 75.0. Higher scores mean more depression, and hence worse.
Validated Patient Reported Outcomes (PROs) - Patient Determined Disease Steps (PDDS)	2 months	Change in PDDS values between pre and post infusion.

Trial Locations

Locations (1)

Amerita; 🇺🇸 Centennial, Colorado, United States