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 (PRIMA-102)

July 20, 2026 updated by: Aqtual, Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1410

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Arizona Arthritis & Rheumatology Research
    • California
      • Apple Valley, California, United States, 92307
        • Medvin Clinical Research - Apple Valley
      • Covina, California, United States, 91722
        • Medvin Clinical Research - Covina
      • Riverside, California, United States, 92518
        • Medvin Clinical Research - Riverside
      • Tujunga, California, United States, 91042
        • Medvin Clinical Research - Tujunga
      • Whittier, California, United States, 90602
        • Medvin Clinical Research - Whittier
    • Florida
      • Aventura, Florida, United States, 33180
        • AARDS Research, Inc
      • Avon Park, Florida, United States, 33825
        • Highlands Advanced Rheumatology and Arthritis Center (HARAC)
      • Clearwater, Florida, United States, 33765
        • Bay Area Rheumatology
      • Coral Springs, Florida, United States, 33065
        • Believe Clinical Trials
      • Hollywood, Florida, United States, 33024
        • Gnp Research
      • Margate, Florida, United States, 33063
        • Life Clinical Trials
      • Palm Beach Gardens, Florida, United States, 33410
        • Vitalia Medical Research
      • Sun City Center, Florida, United States, 33573
        • Shine a Light Research
      • Tamarac, Florida, United States, 33321
        • West Broward Rheumatology Associates
    • Idaho
      • Boise, Idaho, United States, 83712
        • St. Luke's Clinic
    • Illinois
      • Skokie, Illinois, United States, 60076
        • Arnold Arthritis & Rheumatology
      • Willowbrook, Illinois, United States, 60527
        • Illinois Bone and Joint Institute
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Lake Cumberland Rheumatology
    • Michigan
      • Saint Clair Shores, Michigan, United States, 48082
        • Clinical Research Institute of Michigan
    • Minnesota
      • Eagan, Minnesota, United States, 55121
        • St. Paul Rheumatology
    • Missouri
      • Kansas City, Missouri, United States, 64151
        • AARA/Kansas City Physician Partners
    • New Hampshire
      • Henniker, New Hampshire, United States, 03242
        • New England Rheumatology & Osteoporosis
    • New Jersey
      • Voorhees Township, New Jersey, United States, 08043
        • Arthritis Rheumatism and Bone Disease Associates
      • West Long Branch, New Jersey, United States, 07764
        • Sahni Rheumatology & Therapy
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Center For Rheumatology
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Arthritis and Osteoporosis Consultants of the Carolinas
      • Leland, North Carolina, United States, 28451
        • Cape Fear Arthritis Care
      • Raleigh, North Carolina, United States, 27612
        • Triangle Arthritis & Rheumatology
      • Wilmington, North Carolina, United States, 28401
        • Carolina Arthritis Associates
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • AARA/Rheumatic Diseases Clinic of Oklahoma
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clinical Research
      • Philadelphia, Pennsylvania, United States, 19152
        • Arthritis Group Rheumatology
      • Philadelphia, Pennsylvania, United States, 19152
        • PA Regional Center for Arthritis and Osteoporosis Research
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Health Specialists/Trial Management Associates
    • Texas
      • Baytown, Texas, United States, 77521
        • Accurate Clinical Management
      • Bellaire, Texas, United States, 77401
        • Rheumatology Care Center
      • Fort Worth, Texas, United States, 76109
        • AARA Clinical Research/Lone Star Arthritis and Rheumatology
      • Houston, Texas, United States, 77089
        • Accurate Clinical Research
      • The Woodlands, Texas, United States, 77382
        • Advanced Rheumatology of Houston
    • Washington
      • Bellevue, Washington, United States, 98004
        • Overlake Arthritis and Osteoporosis Center
      • Spokane, Washington, United States, 99204
        • Arthritis Northwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adults diagnosed with RA who are planning to initiate a new bDMARD +/- csDMARD or tsDMARD +/- csDMARD treatment

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Unsuitable for participation in the opinion of the principal investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Adults diagnosed with RA
Adults diagnosed with RA who are planning to initiate a new bDMARD +/- csDMARD or tsDMARD +/- csDMARD treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Approximately 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aqtual, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Diana Abdueva, CEO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 29, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRIMA - 102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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