A Clinical Utility Study of PrismRA for Rheumatoid Arthritis

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

Completed

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Arizona Arthritis, Chandler, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Therapeutic Response

Time frame: 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

Sponsors and collaborators

Lead sponsor

Scipher Medicine

Industry

Registry information

Official study title

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

Acronym: DRIVE

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Dec 17, 2021
Registry last updated: Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed