Home infusions of ocrelizumab for multiple sclerosis patients
Evaluating the Feasibility of Pandemic Forward, Telehealth Based Home Based Infusions
This study tests whether giving ocrelizumab infusions at home is safe and effective for people with multiple sclerosis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Drugs / interventions | ocrelizumab |
| Locations | 1 site (Centennial, Colorado) |
| Trial ID | NCT04650321 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of administering ocrelizumab infusions at home for patients with multiple sclerosis. It involves monitoring for infusion reactions and adverse events, comparing these rates to existing studies. Additionally, patient-reported outcomes will be assessed to evaluate changes before and after the infusion. The study aims to provide insights into the feasibility of home-based treatment for MS patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-55 with a diagnosis of primary progressive or relapsing multiple sclerosis who are current patients at the Rocky Mountain MS Center.
Not a fit: Patients who are not currently active at the Rocky Mountain MS Center or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance patient convenience and comfort while maintaining treatment efficacy for multiple sclerosis.
How similar studies have performed: Other studies have explored home infusion therapies, showing promising results, but this specific approach with ocrelizumab is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Centennial, Colorado
- Amerita — Centennial, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Timothy L Vollmer, MD — University of Colorado, Denver
- Study coordinator: Brooke Valdez, BS
- Email: brooke.valdez@cuanshutz.edu
- Phone: 303-724-2635
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.