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
1 other identifier
observational
1,410
1 country
42
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
Longer than P75 for all trials
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 29, 2023
CompletedFirst Submitted
Initial submission to the registry
June 30, 2023
CompletedFirst Posted
Study publicly available on registry
July 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2028
July 21, 2026
July 1, 2026
4.5 years
June 30, 2023
July 20, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical Response Prediction
This study aims to identify cfDNA signatures that predict response to specific bDMARD or tsDMARD therapies for RA treatment.
Approximately 3 months
Study Arms (1)
Adults diagnosed with RA
Adults diagnosed with RA who are planning to initiate a new bDMARD +/- csDMARD or tsDMARD +/- csDMARD treatment
Eligibility Criteria
Adults diagnosed with RA who are planning to initiate a new bDMARD +/- csDMARD or tsDMARD +/- csDMARD treatment
You may qualify if:
- 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.
You may not qualify if:
- Unsuitable for participation in the opinion of the principal investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aqtual, Inc.lead
Study Sites (42)
Arizona Arthritis & Rheumatology Research
Phoenix, Arizona, 85032, United States
Medvin Clinical Research - Apple Valley
Apple Valley, California, 92307, United States
Medvin Clinical Research - Covina
Covina, California, 91722, United States
Medvin Clinical Research - Riverside
Riverside, California, 92518, United States
Medvin Clinical Research - Tujunga
Tujunga, California, 91042, United States
Medvin Clinical Research - Whittier
Whittier, California, 90602, United States
AARDS Research, Inc
Aventura, Florida, 33180, United States
Highlands Advanced Rheumatology and Arthritis Center (HARAC)
Avon Park, Florida, 33825, United States
Bay Area Rheumatology
Clearwater, Florida, 33765, United States
Believe Clinical Trials
Coral Springs, Florida, 33065, United States
GNP Research
Hollywood, Florida, 33024, United States
Life Clinical Trials
Margate, Florida, 33063, United States
Vitalia Medical Research
Palm Beach Gardens, Florida, 33410, United States
Shine a Light Research
Sun City Center, Florida, 33573, United States
West Broward Rheumatology Associates
Tamarac, Florida, 33321, United States
St. Luke's Clinic
Boise, Idaho, 83712, United States
Arnold Arthritis & Rheumatology
Skokie, Illinois, 60076, United States
Illinois Bone and Joint Institute
Willowbrook, Illinois, 60527, United States
Lake Cumberland Rheumatology
New Albany, Indiana, 47150, United States
Clinical Research Institute of Michigan
Saint Clair Shores, Michigan, 48082, United States
St. Paul Rheumatology
Eagan, Minnesota, 55121, United States
AARA/Kansas City Physician Partners
Kansas City, Missouri, 64151, United States
New England Rheumatology & Osteoporosis
Henniker, New Hampshire, 03242, United States
Arthritis Rheumatism and Bone Disease Associates
Voorhees Township, New Jersey, 08043, United States
Sahni Rheumatology & Therapy
West Long Branch, New Jersey, 07764, United States
Albuquerque Center for Rheumatology
Albuquerque, New Mexico, 87102, United States
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, 28207, United States
Cape Fear Arthritis Care
Leland, North Carolina, 28451, United States
Triangle Arthritis & Rheumatology
Raleigh, North Carolina, 27612, United States
Carolina Arthritis Associates
Wilmington, North Carolina, 28401, United States
AARA/Rheumatic Diseases Clinic of Oklahoma
Oklahoma City, Oklahoma, 73102, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Arthritis Group Rheumatology
Philadelphia, Pennsylvania, 19152, United States
PA Regional Center for Arthritis and Osteoporosis Research
Philadelphia, Pennsylvania, 19152, United States
Carolina Health Specialists/Trial Management Associates
Myrtle Beach, South Carolina, 29572, United States
Accurate Clinical Management
Baytown, Texas, 77521, United States
Rheumatology Care Center
Bellaire, Texas, 77401, United States
AARA Clinical Research/Lone Star Arthritis and Rheumatology
Fort Worth, Texas, 76109, United States
Accurate Clinical Research
Houston, Texas, 77089, United States
Advanced Rheumatology of Houston
The Woodlands, Texas, 77382, United States
Overlake Arthritis and Osteoporosis Center
Bellevue, Washington, 98004, United States
Arthritis Northwest
Spokane, Washington, 99204, United States
Biospecimen
Whole Blood \& processed plasma
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Diana Abdueva
CEO
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2023
First Posted
July 10, 2023
Study Start
June 29, 2023
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
July 21, 2026
Record last verified: 2026-07