Blood test to predict treatment options for rheumatoid arthritis patients
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
This study is testing a blood test that looks at genetic information to see if it can help find better treatment options for rheumatoid arthritis patients who haven’t had success with previous therapies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1410 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Aqtual, Inc. Industry-sponsored |
| Locations | 1 site (Charlotte, North Carolina) |
| Trial ID | NCT05936970 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate a cfDNA-based blood test that analyzes genetic, transcriptomic, and epigenetic information to help predict the best treatment options for rheumatoid arthritis patients who have not responded adequately or are intolerant to previous therapies. Participants will be enrolled after screening and will start a new bDMARD or tsDMARD therapy as per standard care. The study will assess treatment response and disease activity at a 12-week follow-up visit, with blood samples collected for analysis at both baseline and follow-up.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of rheumatoid arthritis who have previously been treated with at least one csDMARD, bDMARD, or tsDMARD and are planning to start a new treatment.
Not a fit: Patients who are not suitable for participation as determined by the principal investigator will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a personalized approach to treatment for rheumatoid arthritis, improving outcomes for patients with inadequate responses to existing therapies.
How similar studies have performed: While this approach is innovative, similar studies using cfDNA analysis for treatment prediction in other conditions have shown promise, suggesting potential for success in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Charlotte, North Carolina
- Arthritis and Osteoporosis Consultants of the Carolinas — Charlotte, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Aqtual Study Support
- Email: studysupport@aqtual.com
- Phone: 341-208-8569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.