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New treatment option for Multiple Sclerosis
Official title Home Based Infusions for Ocrelizumab
ClinicalTrials.gov ID: NCT04650321
What this study is testing
What is Ocrelizumab at home?
Ocrelizumab at home is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple sclerosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal is to assess the safety and effectiveness of home ocrelizumab infusion.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join 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.
You likely 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...
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Centennial, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Centennial, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.