Home Based Infusions for Ocrelizumab

Multiple Sclerosis Clinical Trial

Official title:

Evaluating the Feasibility of Pandemic Forward, Telehealth Based Home Based Infusions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04650321
• Other study ID #: 20-2153
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2021
• Est. completion date: August 31, 2021

Study information

• Verified date: June 2021
• Source: University of Colorado, Denver
• Contact: Brooke Valdez, BS
• Phone: 303-724-2635
• Email: brooke.valdez[@]cuanshutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Drug:
• Ocrelizumab at home
Patients will receive ocrelizumab infusion at home.

Locations

Country	Name	City	State
United States	Amerita	Centennial	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Vollmer TL, Cohen JA, Alvarez E, Nair KV, Boster A, Katz J, Pardo G, Pei J, Raut P, Merchant S, MacLean E, Pradhan A, Moss B. Safety results of administering ocrelizumab per a shorter infusion protocol in patients with primary progressive and relapsing mu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severe infusion reactions	Proportion of patients with infusion reactions greater than or equal to 3 on the National Cancer Institute's Common Terminology	24 hours after infusion
Primary	Infusion reactions	Proportion of patients with infusion reactions greater than or equal to 1 on the National Cancer Institute's Common Terminology	24 hours after infusion
Secondary	Severe infusion reactions compared to historic controls.	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.	24 hours after infusion
Secondary	Infusion reactions compared to historic controls.	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.	24 hours after infusion
Secondary	Validated Patient Reported Outcomes (PROs) - PROMIS 10 Physical	Change in PROMIS 10 values between pre and post infusion. Ranges from 10 to 50. Higher numbers indicate better well being.	2 months
Secondary	Validated Patient Reported Outcomes (PROs) - PROMIS 10 Mental	Change in PROMIS 10 values between pre and post infusion. Ranges from 10 to 50. Higher numbers indicate better well being.	2 months
Secondary	Validated Patient Reported Outcomes (PROs) - Neuro-QOL Anxiety	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.	2 months
Secondary	Validated Patient Reported Outcomes (PROs) - Neuro-QOL Depression	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.	2 months
Secondary	Validated Patient Reported Outcomes (PROs) - Patient Determined Disease Steps (PDDS)	Change in PDDS values between pre and post infusion.	2 months
Secondary	Adverse events	Number of adverse events	2 months