NCT04650321 Home Based Infusions for Ocrelizumab
| NCT ID | NCT04650321 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Colorado, Denver |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2021-03-01 |
| Primary Completion | 2021-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 110 participants in total. It began in 2021-03-01 with a primary completion date of 2021-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal is to assess the safety and effectiveness of home ocrelizumab infusion.
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.
Contact & Investigator
Timothy L Vollmer, MD
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT04650321 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04650321 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04650321 currently recruiting?
Yes, NCT04650321 is actively recruiting participants. Contact the research team at brooke.valdez@cuanshutz.edu for enrollment information.
Where is the NCT04650321 trial being conducted?
This trial is being conducted at Centennial, United States.
Who is sponsoring the NCT04650321 clinical trial?
NCT04650321 is sponsored by University of Colorado, Denver. The principal investigator is Timothy L Vollmer, MD at University of Colorado, Denver. The trial plans to enroll 110 participants.
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