Prospective, Multi-Center, Observational, Whole Blood Specimen Collection Study in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to bDMARD or tsDMARD +/- csDMARD Changing Treatment to a bDMARD or tsDMARD Treatment +/- csDMARD

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Prospective, Multi-Center, Observational, Whole Blood Specimen Collection Study in Participants With Rheumatoid Arthritis With Inadequate Response or Intolerance to bDMARD or tsDMARD +/- csDMARD Changing Treatment to a bDMARD or tsDMARD Treatment +/- csDMARD

Conditions
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Rheumatoid Arthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to understand and provide written informed consent. Male or female ≥18 years of age at enrollment. Diagnosis of Rheumatoid Arthritis by ACR/EULAR 2010 classification criteria at the time of enrollment. Prior treatment with at least 1 bDMARD or tsDMARD but not more than 4 prior bDMARD or tsDMARD therapies, with discontinuation of the most recent bDMARD or tsDMARD within 3 months of enrollment. Planning to initiate a new bDMARD or tsDMARD, within 1 month after enrollment. Moderate to high Clinical Disease Activity Index (CDAI) of (>10) at the time of screening. Exclusion Criteria: Current or prior cancer within 2 years of enrollment. Note: Current or prior in situ cancer or basal or squamous cell skin cancer are not exclusionary. Any known form of chronic diseases of autoimmune conditions overlapping with RA, including but not limited to mixed connective tissue disease (MCTD) or systemic lupus erythematosus (SLE). Current acute active infection requiring treatment with antibiotics at the time of enrollment. Received any experimental therapeutic treatment (i.e., not approved by the FDA) within 90 days prior to enrollment. Body-mass index (BMI)<18 kg/m2 or (BMI)>40 kg/m2 at screening. Active fibromyalgia, where in the opinion of the investigator there could be confounding results in assessing RA disease activity scoring. Initiation or discontinuation of glucocorticoids or glucocorticoid use >10 mg per day within 4 weeks prior to enrollment or planning to initiate glucocorticoid treatment >10 mg per day during the study. Initiation of new DMARD within 4 weeks prior to enrollment. Unstable oral opiate use within 2 weeks prior to enrollment or concomitant use of strong oral opiates as determined after Investigator consultation with the Sponsor. Otherwise, unsuitable for participation in the opinion of the principal investigator.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults diagnosed with RA<br>Adults diagnosed with RA and with inadequate response or intolerance to at least one bDMARD or tsDMARD and who are planning to initiate a new bDMARD +/- csDMARD or tsDMARD +/- csDMARD treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |