NCT04650321

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P75+ for phase_4 multiple-sclerosis

Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_4 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

June 10, 2021

Status Verified

June 1, 2021

Enrollment Period

6 months

First QC Date

November 16, 2020

Last Update Submit

June 8, 2021

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (8)

  • Severe infusion reactions compared to historic controls.

    24 hours after infusion

  • Infusion reactions compared to historic controls.

    24 hours after infusion

  • Validated Patient Reported Outcomes (PROs) - PROMIS 10 Physical

    2 months

  • Validated Patient Reported Outcomes (PROs) - PROMIS 10 Mental

    2 months

  • Validated Patient Reported Outcomes (PROs) - Neuro-QOL Anxiety

    2 months

  • +3 more secondary outcomes

Study Arms (1)

Home infusion of ocrelizumab

EXPERIMENTAL

Patients will receive infusion of ocrelizumab at home, instead of at clinic.

Drug: Ocrelizumab at home

Interventions

Ocrelizumab at homeDRUG

Patients will receive ocrelizumab infusion at home.

Home infusion of ocrelizumab

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amerita

Centennial, Colorado, 80112, United States

RECRUITING

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

    PMID: 33045496RESULT

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Timothy L Vollmer, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brooke Valdez, BS

CONTACT

303-724-2635brooke.valdez@cuanshutz.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single arm clinical trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2020

First Posted

December 2, 2020

Study Start

March 1, 2021

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

June 10, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)