Amerita
Centennial, Colorado, 80112, United States
Location status: Recruiting
NCT Number: NCT04650321
The goal is to assess the safety and effectiveness of home ocrelizumab infusion.
Interested in participating?
Request Info18 year–55 year
All sexes
Interventional
Phase 4
Centennial, Colorado, 80112, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive ocrelizumab infusion at home.
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
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
Time frame: 24 hours after infusion
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.
Time frame: 24 hours after infusion
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.
Time frame: 2 months
Change in PROMIS 10 values between pre and post infusion. Ranges from 10 to 50. Higher numbers indicate better well being.
Time frame: 2 months
Change in PROMIS 10 values between pre and post infusion. Ranges from 10 to 50. Higher numbers indicate better well being.
Time frame: 2 months
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.
Time frame: 2 months
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.
Time frame: 2 months
Change in PDDS values between pre and post infusion.
Time frame: 2 months
Number of adverse events
Contact information is provided by the study sponsor or research team.
University of Colorado, Denver
Other
Evaluating the Feasibility of Pandemic Forward, Telehealth Based Home Based Infusions
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03816345
Arthritis, Arthritis, Psoriatic
Birmingham, Alabama, United States
View Trial DetailsNCT07736482
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Afyonkarahisar, Merkez, Turkey (Türkiye)
View Trial DetailsNCT07738978
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Cleveland, Ohio, United States
View Trial DetailsNCT07738120
Autoimmune Diseases, Autoimmune Diseases of the Nervous System
Pontevedra, Spain
View Trial Details