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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05936970
• Other study ID #: PRIMA - 102
• Status: Recruiting
• Start date: June 29, 2023
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: Aqtual, Inc.
• Contact: Aqtual Study Support
• Phone: 341-208-8581
• Email: studysupport[@]aqtual.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 830
• Est. completion date: September 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	Arthritis and Osteoporosis Consultants of the Carolinas	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Aqtual, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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