Rheumatoid Arthritis
Conditions
Brief summary
A clinical utility study for PrismRA testing therapeutic response in patients with rheumatoid arthritis.
Interventions
None listed
Sponsors
Scipher Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic Response | 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 |
Countries
United States
Outcome results
None listed