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Recruiting NCT04650321

Home Based Infusions for Ocrelizumab

Phase IV Interventional Multiple Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ocrelizumab at home.
Who it may be relevant to
Registry conditions: Multiple Sclerosis. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Severe infusion reactions [Time frame: 24 hours after infusion]
  • Infusion reactions [Time frame: 24 hours after infusion]
Secondary outcome measures (8)
  • Severe infusion reactions compared to historic controls. [Time frame: 24 hours after infusion]
  • Infusion reactions compared to historic controls. [Time frame: 24 hours after infusion]
  • Validated Patient Reported Outcomes (PROs) - PROMIS 10 Physical [Time frame: 2 months]
  • Validated Patient Reported Outcomes (PROs) - PROMIS 10 Mental [Time frame: 2 months]
  • Validated Patient Reported Outcomes (PROs) - Neuro-QOL Anxiety [Time frame: 2 months]
  • Validated Patient Reported Outcomes (PROs) - Neuro-QOL Depression [Time frame: 2 months]
  • Validated Patient Reported Outcomes (PROs) - Patient Determined Disease Steps (PDDS) [Time frame: 2 months]
  • Adverse events [Time frame: 2 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Amerita — Centennial

Publications

  • 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 multiple sclerosis. Mult Scler Relat Disord. 2020 Nov;46:102454. doi: 10.1016/j.msard.2020.102454. Epub 2020 Aug 18. PMID 33045496

Identifiers

NCT: NCT04650321 · 20-2153

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗