RECRUITING

Home Based Infusions for Ocrelizumab

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2021-03-01

Study Completion:2021-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04650321

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Brooke Valdez, BS

CONTACT

303-724-2635

brooke.valdez@cuanshutz.edu

Principal Investigator

Timothy L Vollmer, MD

PRINCIPAL_INVESTIGATOR

University of Colorado - Anschutz Medical Campus

Study Locations (Sites)

Amerita

Centennial, Colorado, 80112

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

Timothy L Vollmer, MD, PRINCIPAL_INVESTIGATOR, University of Colorado - Anschutz Medical Campus

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-01

Study Completion Date2021-08-31

Study Record Updates

Study Start Date2021-03-01

Study Completion Date2021-08-31

Terms related to this study

Additional Relevant MeSH Terms

Multiple Sclerosis