NCT04650321RecruitingPhase 4
Home Based Infusions for Ocrelizumab
Evaluating the Feasibility of Pandemic Forward, Telehealth Based Home Based Infusions
Source: ClinicalTrials.gov · Last updated 10 Jun 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal is to assess the safety and effectiveness of home ocrelizumab infusion.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 16 Nov 2020
- Start date
- 1 Mar 2021
- Primary completion date
- 31 Aug 2021
- Lead sponsor
- University of Colorado, Denver
- Diseases
- Multiple sclerosis
- NCT number
- NCT04650321
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 110
- From 1 Mar 2021 to the primary completion date, 31 Aug 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has previously not participated in the SaROD trial at the RMMSC site.
Lab values
- 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.
Other
- Not pregnant, intentions to get pregnant or lactating at the time of final study consent and on the day of infusion.
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amerita Coordinator of this site? Confirm its status | Centennial | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.