Rheumatoid ArthritisDRIVENCT05161234
A Clinical Utility Study of PrismRA for Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Scipher Medicine at 30 sites in United States.
Trial summary
A clinical utility study for PrismRA testing therapeutic response in patients with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 613 participants
- Where
- 30 sitesUnited States
- Study dates
- 3 Mar 2022to 6 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with RA who will have a PrismRA test completed as part of the trial.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
Annapolis Rheumatology
Annapolis, Maryland, 21401
HARAC Research Corp.
Avon Park, Florida, 33825
Wajeeha Yousaf, MD, PA
Bellaire, Texas, 77401
Arizona Arthritis
Chandler, Arizona, 85225
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, 28207
Adriana Pop Moody MD Clinic PA// Corpus Christi Rheumatology Clinic
Corpus Christi, Texas, 78404
Medvin Clinical Research//Covina Arthritis Clinic
Covina, California, 91722
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
St. Paul Rheumatology
Eagan, Minnesota, 55121
Mid-Atlantic Rheumatology
Glen Burnie, Maryland, 21061
Southland Arthritis
Hemet, California, 92543
GNP Research//Mark Jaffe, MD PA
Hollywood, Florida, 33024
Laila Hassan, MD, PA
Houston, Texas, 77089
Houston Rheumatology & Arthritis Specialists, PLLC
Katy, Texas, 77494
Advanced Rheumatology
Lansing, Michigan, 48910
Innovative Health Research
Las Vegas, Nevada, 89128
Cape Fear Arthritis Care
Leland, North Carolina, 28451
Rheumatology Associates, PLLC
Louisville, Kentucky, 40218
Arthritis & Diabetes Clinic, Inc.
Monroe, Louisiana, 71203
Advanced Clinical Research of Orlando
Ocoee, Florida, 34761
Allegheny Health Network
Pittsburgh, Pennsylvania, 15224
ACRC Studies
Poway, California, 92064
Main Rheumatology Associates of South Texas
San Antonio, Texas, 78258
Low Country Rheumatology
Summerville, South Carolina, 29486
Advanced Rheumatology of Houston
The Woodlands, Texas, 77382
Medvin Clinical Research//Cohen Medical Center
Thousand Oaks, California, 91360
Medvin Clinical Research//Foothill Arthritis Clinic
Tujunga, California, 91042
Medvin Clinical Research/Charles Weidmann, Inc.
Van Nuys, California, 91405
Medvin Clinical Research//Amicus Arthritis
Whittier, California, 90602
Center for Rheumatology Research
Woodland Hills, California, 91364
About this study
Official title: 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.
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic Response
Proportion of moderate to severe disease activity patients that achieve measurable clinical outcomes therapeutic response after initiation of a non-csDMARD therapy
Measured: 12-or 24-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start3 Mar 2022
- Primary completion6 Dec 2023
- Study completion6 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 613 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scipher Medicine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161234
- Sponsor's protocol ID
- Scipher-RA-005
- Acronym
- DRIVE
- Status last verified
- Mar 2024
- First submitted
- 3 Dec 2021
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Utility Study of PrismRA Testing Therapeutic Response for Rheumatoid Arthritis (DRIVE)
- ClinicalTrials.gov ID
- NCT05161234
- Acronym / sponsor ID
- DRIVE / Scipher-RA-005
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 613 participants (actual)
- Lead sponsor
- Scipher MedicineIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 6 Dec 2023 (actual)
- Study completion
- 6 Dec 2023 (actual)
- First posted
- 17 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A clinical utility study for PrismRA testing therapeutic response in patients with rheumatoid arthritis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with RA who will have a PrismRA test completed as part of the trial.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Scipher Medicine at 30 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic Response (time frame: 12-or 24-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.