Home Based Infusions for Ocrelizumab
Recruiting now · Phase 4
Conditions studied: Multiple Sclerosis
In brief
The goal is to assess the safety and effectiveness of home ocrelizumab infusion.
Key facts
- Study ID
- NCT04650321
- Run by
- University of Colorado, Denver
- People needed
- 110
- Starts
- 2021-03-01
- Expected to finish
- 2021-08-31
- Last updated by the study team
- 2021-06-10
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Amerita — Centennial, Colorado, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.