Multiple SclerosisPhase 4NCT04650321
Home Based Infusions for Ocrelizumab
A Phase 4 study testing Ocrelizumab at home in people with Multiple Sclerosis, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal is to assess the safety and effectiveness of home ocrelizumab infusion. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Ocrelizumab at home
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 31 Aug 2021
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Amerita
Centennial, Colorado, 80112
Kathline Perkins, RN, 303-355-4745, kperkins@ameritaiv.com
About this study
Official title: Evaluating the Feasibility of Pandemic Forward, Telehealth Based Home Based Infusions
The goal is to assess the safety and effectiveness of home ocrelizumab infusion.
Read the detailed description
The safety of home ocrelizumab infusion will be assessed by monitoring for infusion reactions and adverse events, and comparing proportions/rates to existing studies. Patient reported outcomes (PROs) will compare pre to post infusion.
- Conditions
- Multiple Sclerosis
- Being tested
- Ocrelizumab at home
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocrelizumab at homeDrug
Patients will receive ocrelizumab infusion at home.
| Study group | Role | What they receive |
|---|---|---|
| Home infusion of ocrelizumab | Experimental | Patients will receive infusion of ocrelizumab at home, instead of at clinic. Receives: Drug: Ocrelizumab at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe infusion reactions
Proportion of patients with infusion reactions greater than or equal to 3 on the National Cancer Institute's Common Terminology
Measured: 24 hours after infusion
Infusion reactions
Proportion of patients with infusion reactions greater than or equal to 1 on the National Cancer Institute's Common Terminology
Measured: 24 hours after infusion
Secondary outcomes (8)
Severe infusion reactions compared to historic controls.
Difference in proportion of patients with infusion reactions greater than or equal to 3 on the National Cancer Institute's Common Terminology between home infusion and the CHORDS and ENSEMBLE historical controls.
Measured: 24 hours after infusion
Infusion reactions compared to historic controls.
Difference in proportion of patients with infusion reactions greater than or equal to 1 on the National Cancer Institute's Common Terminology between home infusion and the CHORDS and ENSEMBLE historical controls.
Measured: 24 hours after infusion
Validated Patient Reported Outcomes (PROs) - PROMIS 10 Physical
Change in PROMIS 10 values between pre and post infusion. Ranges from 10 to 50. Higher numbers indicate better well being.
Measured: 2 months
Validated Patient Reported Outcomes (PROs) - PROMIS 10 Mental
Change in PROMIS 10 values between pre and post infusion. Ranges from 10 to 50. Higher numbers indicate better well being.
Measured: 2 months
Validated Patient Reported Outcomes (PROs) - Neuro-QOL Anxiety
Change in Neuro-QOL Anxiety values between pre and post infusion. Score is transformed to a T score, with population mean of 50 and population standard deviation of 10. T score can range from 36.4 to 76.8. Higher scores mean more anxiety, and hence worse.
Measured: 2 months
Validated Patient Reported Outcomes (PROs) - Neuro-QOL Depression
Change in Neuro-QOL Depression values between pre and post infusion. Score is transformed to a T score, with population mean of 50 and population standard deviation of 10. T score can range from 36.9 to 75.0. Higher scores mean more depression, and hence worse.
Measured: 2 months
Validated Patient Reported Outcomes (PROs) - Patient Determined Disease Steps (PDDS)
Change in PDDS values between pre and post infusion.
Measured: 2 months
Adverse events
Number of adverse events
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start1 Mar 2021
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm clinical trial.
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Timothy L Vollmer, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650321
- Sponsor's protocol ID
- 20-2153
- Status last verified
- Jun 2021
- First submitted
- 16 Nov 2020
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vollmer TL, Cohen JA, Alvarez E, Nair KV, Boster A, Katz J, Pardo G, Pei J, Raut P, Merchant S, MacLean E, Pradhan A, Moss B. Safety results of administering ocrelizumab per a shorter infusion protocol in patients with primary progressive and relapsing multiple sclerosis. Mult Scler Relat Disord. 2020 Nov;46:102454. doi: 10.1016/j.msard.2020.102454. Epub 2020 Aug 18.
PubMed 33045496
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility of Pandemic Forward, Telehealth Based Home Based Infusions
- ClinicalTrials.gov ID
- NCT04650321
- Acronym / sponsor ID
- 20-2153
- Conditions
- Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal is to assess the safety and effectiveness of home ocrelizumab infusion.
Detailed description
The safety of home ocrelizumab infusion will be assessed by monitoring for infusion reactions and adverse events, and comparing proportions/rates to existing studies. Patient reported outcomes (PROs) will compare pre to post infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Home infusion of ocrelizumab | Experimental | Drug: Ocrelizumab at homePatients will receive infusion of ocrelizumab at home, instead of at clinic. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ocrelizumab at homePatients will receive ocrelizumab infusion at home. | Drug | Home infusion of ocrelizumab |
Primary outcome
Severe infusion reactions
Time frame: 24 hours after infusion
Proportion of patients with infusion reactions greater than or equal to 3 on the National Cancer Institute's Common Terminology
Infusion reactions
Time frame: 24 hours after infusion
Proportion of patients with infusion reactions greater than or equal to 1 on the National Cancer Institute's Common Terminology
8 secondary outcomes
Severe infusion reactions compared to historic controls.
Time frame: 24 hours after infusion
Infusion reactions compared to historic controls.
Time frame: 24 hours after infusion
Validated Patient Reported Outcomes (PROs) - PROMIS 10 Physical
Time frame: 2 months
Validated Patient Reported Outcomes (PROs) - PROMIS 10 Mental
Time frame: 2 months
Validated Patient Reported Outcomes (PROs) - Neuro-QOL Anxiety
Time frame: 2 months
Validated Patient Reported Outcomes (PROs) - Neuro-QOL Depression
Time frame: 2 months
Validated Patient Reported Outcomes (PROs) - Patient Determined Disease Steps (PDDS)
Time frame: 2 months
Adverse events
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2021.
- Results publication: PubMed 33045496Vollmer TL, Cohen JA, Alvarez E, Nair KV, Boster A, Katz J, Pardo G, Pei J, Raut P, Merchant S, MacLean E, Pradhan A, Moss B. Safety results of administering ocrelizumab per a shorter infusion protocol in patients with primary progressive and relapsing multiple sclerosis. Mult Scler Relat Disord. 2020 Nov;46:102454. doi: 10.1016/j.msard.2020.102454. Epub 2020 Aug 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Timothy L Vollmer, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ocrelizumab at home in people with Multiple Sclerosis, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brooke Valdez, BS (303-724-2635, brooke.valdez@cuanshutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe infusion reactions (time frame: 24 hours after infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04650321, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2021.