Clinical trial NCT05161234: A Clinical Utility Study of PrismRA for Rheumatoid Arthritis
Official title: A Clinical Utility Study of PrismRA Testing Therapeutic Response for Rheumatoid Arthritis (DRIVE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Scipher Medicine
Sponsor class: INDUSTRY
First posted: 2021-12-17
Enrollment: 613
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with RA who will have a PrismRA test completed as part of the trial.

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


Eligibility criteria: 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

Primary outcomes:
measure: Therapeutic Response
timeFrame: 12-or 24-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Arizona Arthritis
state: Arizona
city: Covina
country: United States
facility: Medvin Clinical Research//Covina Arthritis Clinic
state: California
city: Hemet
country: United States
facility: Southland Arthritis
state: California
city: Poway
country: United States
facility: ACRC Studies
state: California
city: Thousand Oaks
country: United States
facility: Medvin Clinical Research//Cohen Medical Center
state: California
city: Tujunga
country: United States
facility: Medvin Clinical Research//Foothill Arthritis Clinic
state: California
city: Van Nuys
country: United States
facility: Medvin Clinical Research/Charles Weidmann, Inc.
state: California
city: Whittier
country: United States
facility: Medvin Clinical Research//Amicus Arthritis
state: California
city: Woodland Hills
country: United States
facility: Center for Rheumatology Research
state: California
city: Avon Park
country: United States
facility: HARAC Research Corp.
state: Florida
city: Hollywood
country: United States
facility: GNP Research//Mark Jaffe, MD PA
state: Florida
city: Ocoee
country: United States
facility: Advanced Clinical Research of Orlando
state: Florida
city: Louisville
country: United States
facility: Rheumatology Associates, PLLC
state: Kentucky
city: Monroe
country: United States
facility: Arthritis & Diabetes Clinic, Inc.
state: Louisiana
city: Annapolis
country: United States
facility: Annapolis Rheumatology
state: Maryland
city: Glen Burnie
country: United States
facility: Mid-Atlantic Rheumatology
state: Maryland
city: Lansing
country: United States
facility: Advanced Rheumatology
state: Michigan
city: Eagan
country: United States
facility: St. Paul Rheumatology
state: Minnesota
city: Las Vegas
country: United States
facility: Innovative Health Research
state: Nevada
city: Charlotte
country: United States
facility: Arthritis and Osteoporosis Consultants of the Carolinas
state: North Carolina
city: Leland
country: United States
facility: Cape Fear Arthritis Care
state: North Carolina
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: Summerville
country: United States
facility: Low Country Rheumatology
state: South Carolina
city: Bellaire
country: United States
facility: Wajeeha Yousaf, MD, PA
state: Texas
city: Corpus Christi
country: United States
facility: Adriana Pop Moody MD Clinic PA// Corpus Christi Rheumatology Clinic
state: Texas
city: Houston
country: United States
facility: Laila Hassan, MD, PA
state: Texas
city: Katy
country: United States
facility: Houston Rheumatology & Arthritis Specialists, PLLC
state: Texas
city: San Antonio
country: United States
facility: Main Rheumatology Associates of South Texas
state: Texas
city: The Woodlands
country: United States
facility: Advanced Rheumatology of Houston
state: Texas
Study officials:
References: