Rheumatoid ArthritisNCT05936970
Prospective, Multi-Center, Observational, Whole Blood Specimen Collection Study in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to a DMARD Starting a New bDMARD or tsDMARD Treatment +/- csDMARD
An observational study of Rheumatoid Arthritis, run by Aqtual, Inc. at 42 sites in United States.
Trial summary
The primary goal of this study is to assess a cfDNA-based blood test using genetic, transcriptomic and/or epigenetic information to help doctors predict the best treatment options for rheumatoid arthritis (RA) patients with inadequate response or intolerance to previous therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 1,410 participants
- Where
- 42 sitesUnited States
- Study dates
- 29 Jun 2023to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adults diagnosed with RA who are planning to initiate a new bDMARD +/- csDMARD or tsDMARD +/- csDMARD treatment
Who may be able to join
- Ability to understand and provide written informed consent.
- Male or female ≥18 years of age at enrollment.
- Diagnosis of Rheumatoid Arthritis at the time of enrollment.
- Prior treatment with at least 1 csDMARD, bDMARD, or tsDMARD
- Planning to initiate a new bDMARD (+/- csDMARD) or tsDMARD (+/- csDMARD), within 1 month after enrollment.
- Moderate to high Clinical Disease Activity Index (CDAI) of (>10) with a minimum 4 tender joints and 4 swollen joints at the time of screening.
Who cannot join
- Unsuitable for participation in the opinion of the principal investigator.
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Albuquerque Center for Rheumatology
Albuquerque, New Mexico, 87102
Medvin Clinical Research - Apple Valley
Apple Valley, California, 92307
AARDS Research, Inc
Aventura, Florida, 33180
Highlands Advanced Rheumatology and Arthritis Center (HARAC)
Avon Park, Florida, 33825
Accurate Clinical Management
Baytown, Texas, 77521
Rheumatology Care Center
Bellaire, Texas, 77401
Overlake Arthritis and Osteoporosis Center
Bellevue, Washington, 98004
St. Luke's Clinic
Boise, Idaho, 83712
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, 28207
Bay Area Rheumatology
Clearwater, Florida, 33765
Believe Clinical Trials
Coral Springs, Florida, 33065
Medvin Clinical Research - Covina
Covina, California, 91722
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
St. Paul Rheumatology
Eagan, Minnesota, 55121
AARA Clinical Research/Lone Star Arthritis and Rheumatology
Fort Worth, Texas, 76109
New England Rheumatology & Osteoporosis
Henniker, New Hampshire, 03242
GNP Research
Hollywood, Florida, 33024
Accurate Clinical Research
Houston, Texas, 77089
AARA/Kansas City Physician Partners
Kansas City, Missouri, 64151
Cape Fear Arthritis Care
Leland, North Carolina, 28451
Life Clinical Trials
Margate, Florida, 33063
Carolina Health Specialists/Trial Management Associates
Myrtle Beach, South Carolina, 29572
Lake Cumberland Rheumatology
New Albany, Indiana, 47150
AARA/Rheumatic Diseases Clinic of Oklahoma
Oklahoma City, Oklahoma, 73102
Vitalia Medical Research
Palm Beach Gardens, Florida, 33410
Arthritis Group Rheumatology
Philadelphia, Pennsylvania, 19152
PA Regional Center for Arthritis and Osteoporosis Research
Philadelphia, Pennsylvania, 19152
Arizona Arthritis & Rheumatology Research
Phoenix, Arizona, 85032
Triangle Arthritis & Rheumatology
Raleigh, North Carolina, 27612
Medvin Clinical Research - Riverside
Riverside, California, 92518
Clinical Research Institute of Michigan
Saint Clair Shores, Michigan, 48082
Arnold Arthritis & Rheumatology
Skokie, Illinois, 60076
Arthritis Northwest
Spokane, Washington, 99204
Shine a Light Research
Sun City Center, Florida, 33573
West Broward Rheumatology Associates
Tamarac, Florida, 33321
Advanced Rheumatology of Houston
The Woodlands, Texas, 77382
Medvin Clinical Research - Tujunga
Tujunga, California, 91042
Arthritis Rheumatism and Bone Disease Associates
Voorhees Township, New Jersey, 08043
Sahni Rheumatology & Therapy
West Long Branch, New Jersey, 07764
Medvin Clinical Research - Whittier
Whittier, California, 90602
Illinois Bone and Joint Institute
Willowbrook, Illinois, 60527
Carolina Arthritis Associates
Wilmington, North Carolina, 28401
About this study
The primary goal of this study is to assess a cfDNA-based blood test using genetic, transcriptomic and/or epigenetic information to help doctors predict the best treatment options for rheumatoid arthritis (RA) patients with inadequate response or intolerance to previous therapies.
Read the detailed description
PRIMA - 102 aims to predict response to bDMARD or tsDMARD therapy through analysis of cfDNA in blood. PRIMA - 102 will enroll participants with inadequate response or intolerance to previous therapies. Participants will undergo screening and baseline visits, followed by the initiation of new bDMARD or tsDMARD therapy per standard of care. The study will evaluate treatment response and disease activity at a 12-week follow-up visit. Blood will be drawn and Clinical Outcome Assessments performed at baseline and at the 12-week follow-up visit.
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults diagnosed with RA | Adults diagnosed with RA who are planning to initiate a new bDMARD +/- csDMARD or tsDMARD +/- csDMARD treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response Prediction
This study aims to identify cfDNA signatures that predict response to specific bDMARD or tsDMARD therapies for RA treatment.
Measured: Approximately 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start29 Jun 2023
- Primary completionJan 2028 (estimated)
- Study completionJun 2028 (estimated)
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aqtual, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diana Abdueva, Study director, CEO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936970
- Sponsor's protocol ID
- PRIMA - 102
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2023
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-Center, Observational, Whole Blood Specimen Collection Study in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to a DMARD Starting a New bDMARD or tsDMARD Treatment +/- csDMARD
- ClinicalTrials.gov ID
- NCT05936970
- Acronym / sponsor ID
- PRIMA - 102
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,410 participants (estimated)
- Lead sponsor
- Aqtual, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 10 Jul 2023 (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.
The primary goal of this study is to assess a cfDNA-based blood test using genetic, transcriptomic and/or epigenetic information to help doctors predict the best treatment options for rheumatoid arthritis (RA) patients with inadequate response or intolerance to previous therapies.
Detailed description
PRIMA - 102 aims to predict response to bDMARD or tsDMARD therapy through analysis of cfDNA in blood. PRIMA - 102 will enroll participants with inadequate response or intolerance to previous therapies. Participants will undergo screening and baseline visits, followed by the initiation of new bDMARD or tsDMARD therapy per standard of care. The study will evaluate treatment response and disease activity at a 12-week follow-up visit. Blood will be drawn and Clinical Outcome Assessments performed at baseline and at the 12-week follow-up visit.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults diagnosed with RA | – | –Adults diagnosed with RA who are planning to initiate a new bDMARD +/- csDMARD or tsDMARD +/- csDMARD treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults diagnosed with RA who are planning to initiate a new bDMARD +/- csDMARD or tsDMARD +/- csDMARD treatment
Key inclusion criteria (6 listed)
- Ability to understand and provide written informed consent.
- Male or female ≥18 years of age at enrollment.
- Diagnosis of Rheumatoid Arthritis at the time of enrollment.
- Prior treatment with at least 1 csDMARD, bDMARD, or tsDMARD
- Planning to initiate a new bDMARD (+/- csDMARD) or tsDMARD (+/- csDMARD), within 1 month after enrollment.
Key exclusion criteria (1 listed)
- Unsuitable for participation in the opinion of the principal investigator.
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
Clinical Response Prediction
Time frame: Approximately 3 months
This study aims to identify cfDNA signatures that predict response to specific bDMARD or tsDMARD therapies for RA treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Diana Abdueva study director
CEO
42 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 Aqtual, Inc. at 42 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 1 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: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical Response Prediction (time frame: Approximately 3 months). 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 21 Jul 2026.