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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

RECRUITINGSponsored by Aqtual, Inc.
Actively Recruiting
SponsorAqtual, Inc.
Started2023-06-29
Est. completion2025-06
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT05936970

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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.

Conditions2

ArthritisRheumatoid Arthritis

Locations1 site

Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, 28207
Coordinator

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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