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
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Lead
Aqtual, Inc.
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be if
Unsuitable for participation in the opinion of the principal investigator.
Clareo Health | 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
