A Clinical Utility Study of PrismRA for Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT05161234
- Lead Sponsor
- Scipher Medicine
- Brief Summary
A clinical utility study for PrismRA testing therapeutic response in patients with rheumatoid arthritis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 613
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Therapeutic Response 12-or 24-weeks Proportion of moderate to severe disease activity patients that achieve measurable clinical outcomes therapeutic response after initiation of a non-csDMARD therapy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
GNP Research//Mark Jaffe, MD PA
🇺🇸Hollywood, Florida, United States
HARAC Research Corp.
🇺🇸Avon Park, Florida, United States
Annapolis Rheumatology
🇺🇸Annapolis, Maryland, United States
St. Paul Rheumatology
🇺🇸Eagan, Minnesota, United States
Southland Arthritis
🇺🇸Hemet, California, United States
Allegheny Health Network
🇺🇸Pittsburgh, Pennsylvania, United States
Arizona Arthritis
🇺🇸Chandler, Arizona, United States
Advanced Rheumatology
🇺🇸Lansing, Michigan, United States
Medvin Clinical Research//Covina Arthritis Clinic
🇺🇸Covina, California, United States
Medvin Clinical Research//Amicus Arthritis
🇺🇸Whittier, California, United States
Center for Rheumatology Research
🇺🇸Woodland Hills, California, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Wajeeha Yousaf, MD, PA
🇺🇸Bellaire, Texas, United States
ACRC Studies
🇺🇸Poway, California, United States
Medvin Clinical Research//Cohen Medical Center
🇺🇸Thousand Oaks, California, United States
Medvin Clinical Research//Foothill Arthritis Clinic
🇺🇸Tujunga, California, United States
Medvin Clinical Research/Charles Weidmann, Inc.
🇺🇸Van Nuys, California, United States
Advanced Clinical Research of Orlando
🇺🇸Ocoee, Florida, United States
Arthritis & Diabetes Clinic, Inc.
🇺🇸Monroe, Louisiana, United States
Mid-Atlantic Rheumatology
🇺🇸Glen Burnie, Maryland, United States
Arthritis and Osteoporosis Consultants of the Carolinas
🇺🇸Charlotte, North Carolina, United States
Cape Fear Arthritis Care
🇺🇸Leland, North Carolina, United States
Low Country Rheumatology
🇺🇸Summerville, South Carolina, United States
Houston Rheumatology & Arthritis Specialists, PLLC
🇺🇸Katy, Texas, United States
Adriana Pop Moody MD Clinic PA// Corpus Christi Rheumatology Clinic
🇺🇸Corpus Christi, Texas, United States
Advanced Rheumatology of Houston
🇺🇸The Woodlands, Texas, United States
Rheumatology Associates, PLLC
🇺🇸Louisville, Kentucky, United States
Innovative Health Research
🇺🇸Las Vegas, Nevada, United States
Laila Hassan, MD, PA
🇺🇸Houston, Texas, United States
Main Rheumatology Associates of South Texas
🇺🇸San Antonio, Texas, United States