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

Active, not recruiting

Conditions

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

Observational

Enrollment (Estimated)

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 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

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
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

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

Aqtual, Inc.

Investigators

  • 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)

June 29, 2023

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

June 30, 2023

First Submitted That Met QC Criteria

June 30, 2023

First Posted (Actual)

July 10, 2023

Study Record Updates

Last Update Posted (Actual)

July 21, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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