Recruiting

Ocrelizumab

Sponsor:

University of Colorado, Denver

Code:

NCT04650321

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Ocrelizumab at home

Study Details

Brief summary:

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

Conditions

Multiple Sclerosis

Study ID

NCT04650321

Start date

Mar 1, 2021

Status verified date

Jun, 2021

Completion date

Aug 31, 2021

Anticipated

Primary completion date

Aug 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

110 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Home infusion of ocrelizumab

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

Interventions

Ocrelizumab at home

Patients will receive ocrelizumab infusion at home.

Primary outcome measure

  • Severe infusion reactions [ Time Frame: 24 hours after infusion ]
  • Infusion reactions [ Time Frame: 24 hours after infusion ]

Central Contacts and Locations

Central contacts

Brooke Valdez, BS

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

Locations

Amerita

Recruiting

Centennial, Colorado, United States, 80112

Contacts

Kathline Perkins, RN

303-355-4745kperkins@ameritaiv.com

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jun 10, 2021

Last verified

Jun, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2021-06-10.