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

Scipher Medicine

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT05161234

Scipher-RA-005

Details and patient eligibility

About

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

Enrollment: 613 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design