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NCT05161234 Clinical Trial

A Clinical Utility Study of PrismRA for Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— DRIVE  

Official title:
A Clinical Utility Study of PrismRA Testing Therapeutic Response for Rheumatoid Arthritis (DRIVE)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05161234
Other study ID # Scipher-RA-005
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 3, 2022
Est. completion date December 6, 2023

Study information
Verified date March 2024
Source Scipher Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A clinical utility study for PrismRA testing therapeutic response in patients with rheumatoid arthritis.

Recruitment information / eligibility
Status Completed
Enrollment 613
Est. completion date December 6, 2023
Est. primary completion date December 6, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Annapolis Rheumatology Annapolis Maryland
United States HARAC Research Corp. Avon Park Florida
United States Wajeeha Yousaf, MD, PA Bellaire Texas
United States Arizona Arthritis Chandler Arizona
United States Arthritis and Osteoporosis Consultants of the Carolinas Charlotte North Carolina
United States Adriana Pop Moody MD Clinic PA// Corpus Christi Rheumatology Clinic Corpus Christi Texas
United States Medvin Clinical Research//Covina Arthritis Clinic Covina California
United States Altoona Center for Clinical Research Duncansville Pennsylvania
United States St. Paul Rheumatology Eagan Minnesota
United States Mid-Atlantic Rheumatology Glen Burnie Maryland
United States Southland Arthritis Hemet California
United States GNP Research//Mark Jaffe, MD PA Hollywood Florida
United States Laila Hassan, MD, PA Houston Texas
United States Houston Rheumatology & Arthritis Specialists, PLLC Katy Texas
United States Advanced Rheumatology Lansing Michigan
United States Innovative Health Research Las Vegas Nevada
United States Cape Fear Arthritis Care Leland North Carolina
United States Rheumatology Associates, PLLC Louisville Kentucky
United States Arthritis & Diabetes Clinic, Inc. Monroe Louisiana
United States Advanced Clinical Research of Orlando Ocoee Florida
United States Allegheny Health Network Pittsburgh Pennsylvania
United States ACRC Studies Poway California
United States Main Rheumatology Associates of South Texas San Antonio Texas
United States Low Country Rheumatology Summerville South Carolina
United States Advanced Rheumatology of Houston The Woodlands Texas
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 Medvin Clinical Research//Amicus Arthritis Whittier California
United States Center for Rheumatology Research Woodland Hills California

Sponsors (1)
Lead Sponsor Collaborator
Scipher Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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