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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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The goal is to assess the safety and effectiveness of home ocrelizumab infusion.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home infusion of ocrelizumab | Experimental | Patients will receive infusion of ocrelizumab at home, instead of at clinic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocrelizumab at home | Drug | Patients will receive ocrelizumab infusion at home. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Severe infusion reactions | Proportion of patients with infusion reactions greater than or equal to 3 on the National Cancer Institute's Common Terminology | 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 | 24 hours after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours after infusion |
| Infusion reactions compared to historic controls. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brooke Valdez, BS | Contact | 303-724-2635 | brooke.valdez@cuanshutz.edu |
| Name | Affiliation | Role |
|---|---|---|
| Timothy L Vollmer, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amerita | Recruiting | Centennial | Colorado | 80112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33045496 | Result | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 14, 2022 | Jan 10, 2023 | 5 |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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Single arm clinical trial.
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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. |
| 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. | 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. | 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. | 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. | 2 months |
| Validated Patient Reported Outcomes (PROs) - Patient Determined Disease Steps (PDDS) | Change in PDDS values between pre and post infusion. | 2 months |
| Adverse events | Number of adverse events | 2 months |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |