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

Recruiting

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT05936970
• Lead Sponsor: Aqtual, Inc.

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-06-29
• Study First Submitted: 2023-06-30
• Study First Submitted QC: 2023-06-30
• Study First Posted: 2023-07-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1410

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Response Prediction	Approximately 3 months	This study aims to identify cfDNA signatures that predict response to specific bDMARD or tsDMARD therapies for RA treatment.

Trial Locations

Locations (1)

Arthritis and Osteoporosis Consultants of the Carolinas; 🇺🇸 Charlotte, North Carolina, United States