A Clinical Utility Study of PrismRA for Rheumatoid Arthritis (DRIVE)

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

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

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis

• Study Type: Observational
• Enrollment (Actual): 613

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85225
      • Arizona Arthritis
  • California
    • Covina, California, United States, 91722
      • Medvin Clinical Research//Covina Arthritis Clinic
    • Hemet, California, United States, 92543
      • Southland Arthritis
    • Poway, California, United States, 92064
      • ACRC Studies
    • Thousand Oaks, California, United States, 91360
      • Medvin Clinical Research//Cohen Medical Center
    • Tujunga, California, United States, 91042
      • Medvin Clinical Research//Foothill Arthritis Clinic
    • Van Nuys, California, United States, 91405
      • Medvin Clinical Research/Charles Weidmann, Inc.
    • Whittier, California, United States, 90602
      • Medvin Clinical Research//Amicus Arthritis
    • Woodland Hills, California, United States, 91364
      • Center for Rheumatology Research
  • Florida
    • Avon Park, Florida, United States, 33825
      • HARAC Research Corp.
    • Hollywood, Florida, United States, 33024
      • GNP Research//Mark Jaffe, MD PA
    • Ocoee, Florida, United States, 34761
      • Advanced Clinical Research of Orlando
  • Kentucky
    • Louisville, Kentucky, United States, 40218
      • Rheumatology Associates, PLLC
  • Louisiana
    • Monroe, Louisiana, United States, 71203
      • Arthritis & Diabetes Clinic, Inc.
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Annapolis Rheumatology
    • Glen Burnie, Maryland, United States, 21061
      • Mid-Atlantic Rheumatology
  • Michigan
    • Lansing, Michigan, United States, 48910
      • Advanced Rheumatology
  • Minnesota
    • Eagan, Minnesota, United States, 55121
      • St. Paul Rheumatology
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Innovative Health Research
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Arthritis and Osteoporosis Consultants of the Carolinas
    • Leland, North Carolina, United States, 28451
      • Cape Fear Arthritis Care
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center For Clinical Research
    • Pittsburgh, Pennsylvania, United States, 15224
      • Allegheny Health Network
  • South Carolina
    • Summerville, South Carolina, United States, 29486
      • Low Country Rheumatology
  • Texas
    • Bellaire, Texas, United States, 77401
      • Wajeeha Yousaf, MD, PA
    • Corpus Christi, Texas, United States, 78404
      • Adriana Pop Moody MD Clinic PA// Corpus Christi Rheumatology Clinic
    • Houston, Texas, United States, 77089
      • Laila Hassan, MD, PA
    • Katy, Texas, United States, 77494
      • Houston Rheumatology & Arthritis Specialists, PLLC
    • San Antonio, Texas, United States, 78258
      • Main Rheumatology Associates of South Texas
    • The Woodlands, Texas, United States, 77382
      • Advanced Rheumatology of Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with RA who will have a PrismRA test completed as part of the trial.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Scipher Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2022
• Primary Completion (Actual): December 6, 2023
• Study Completion (Actual): December 6, 2023

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: December 3, 2021
• First Posted (Actual): December 17, 2021

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: Scipher-RA-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No