Multiple SclerosisDigital healthDrugPhase 4
What this study is
The goal is to assess the safety and effectiveness of home ocrelizumab infusion.
What's being tested
- Ocrelizumab at home
Intervention · DRUG
Patients will receive ocrelizumab infusion at home.
Study details
- Official title
- Evaluating the Feasibility of Pandemic Forward, Telehealth Based Home Based Infusions
- Sponsor
- University of Colorado, Denver
- Conditions
- Multiple Sclerosis
- Enrolling
- 110 people
- Starts
- 2021-03-01
- Est. completion
- 2021-08-31
- Design
- Open-label, single group, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 55 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openAmerita
Centennial, Colorado, United States
- Kathline Perkins, RN · Contact303-355-4745kperkins@ameritaiv.com
Recruiting
Study team
Sponsor
University of Colorado, Denver
Study ID 20-2153
Principal investigator
Timothy L Vollmer, MD
University of Colorado, Denver
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.