A Clinical Utility Study of PrismRA for Rheumatoid Arthritis
DRIVE
1 other identifier
observational
613
1 country
30
Brief Summary
A clinical utility study for PrismRA testing therapeutic response in patients with rheumatoid arthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2021
CompletedFirst Posted
Study publicly available on registry
December 17, 2021
CompletedStudy Start
First participant enrolled
March 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2023
CompletedMarch 5, 2024
March 1, 2024
1.8 years
December 3, 2021
March 1, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Therapeutic Response
Proportion of moderate to severe disease activity patients that achieve measurable clinical outcomes therapeutic response after initiation of a non-csDMARD therapy
12-or 24-weeks
Eligibility Criteria
Patients with RA who will have a PrismRA test completed as part of the trial.
You may qualify if:
- Age ≥ 18 at time of consent
- Patient must meet the criteria for RA as defined by the 2010 ACR/EULAR classification at Visit 1
- Patient has active, moderate to high, RA with a CDAI of \>10 at Visit 1
- Patient has swollen and tender joint count of ≥ 2 each, as determined by CDAI assessment at Visit 1 using a 28-joint count
- Patient may participate in additional observational studies concurrently
- Patient is willing and able to complete the informed consent process and comply with study procedures and visit schedule
You may not qualify if:
- Patients who are unable to understand the protocol and unable to provide informed consent
- Patients who are not indicated for PrismRA
- Patients who are receiving concurrent treatment with an investigational therapy or have used an investigational therapy less than 4 weeks prior to Visit 1
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Scipher Medicinelead
Study Sites (30)
Arizona Arthritis
Chandler, Arizona, 85225, United States
Medvin Clinical Research//Covina Arthritis Clinic
Covina, California, 91722, United States
Southland Arthritis
Hemet, California, 92543, United States
ACRC Studies
Poway, California, 92064, United States
Medvin Clinical Research//Cohen Medical Center
Thousand Oaks, California, 91360, United States
Medvin Clinical Research//Foothill Arthritis Clinic
Tujunga, California, 91042, United States
Medvin Clinical Research/Charles Weidmann, Inc.
Van Nuys, California, 91405, United States
Medvin Clinical Research//Amicus Arthritis
Whittier, California, 90602, United States
Center for Rheumatology Research
Woodland Hills, California, 91364, United States
HARAC Research Corp.
Avon Park, Florida, 33825, United States
GNP Research//Mark Jaffe, MD PA
Hollywood, Florida, 33024, United States
Advanced Clinical Research of Orlando
Ocoee, Florida, 34761, United States
Rheumatology Associates, PLLC
Louisville, Kentucky, 40218, United States
Arthritis & Diabetes Clinic, Inc.
Monroe, Louisiana, 71203, United States
Annapolis Rheumatology
Annapolis, Maryland, 21401, United States
Mid-Atlantic Rheumatology
Glen Burnie, Maryland, 21061, United States
Advanced Rheumatology
Lansing, Michigan, 48910, United States
St. Paul Rheumatology
Eagan, Minnesota, 55121, United States
Innovative Health Research
Las Vegas, Nevada, 89128, United States
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, 28207, United States
Cape Fear Arthritis Care
Leland, North Carolina, 28451, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, 15224, United States
Low Country Rheumatology
Summerville, South Carolina, 29486, United States
Wajeeha Yousaf, MD, PA
Bellaire, Texas, 77401, United States
Adriana Pop Moody MD Clinic PA// Corpus Christi Rheumatology Clinic
Corpus Christi, Texas, 78404, United States
Laila Hassan, MD, PA
Houston, Texas, 77089, United States
Houston Rheumatology & Arthritis Specialists, PLLC
Katy, Texas, 77494, United States
Main Rheumatology Associates of South Texas
San Antonio, Texas, 78258, United States
Advanced Rheumatology of Houston
The Woodlands, Texas, 77382, United States
Biospecimen
Blood will be collected using PrismRA kit consisting of 1 serum separator and 2 PaxGene tubes.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2021
First Posted
December 17, 2021
Study Start
March 3, 2022
Primary Completion
December 6, 2023
Study Completion
December 6, 2023
Last Updated
March 5, 2024
Record last verified: 2024-03