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

NCT05936970 | Recruiting

• 1 other identifier: PRIMA - 102
• Study Type: observational
• Target: 1,410
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Adults diagnosed with RA

Adults diagnosed with RA who are planning to initiate a new bDMARD +/- csDMARD or tsDMARD +/- csDMARD treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults diagnosed with RA who are planning to initiate a new bDMARD +/- csDMARD or tsDMARD +/- csDMARD treatment

You may qualify 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 qualify if:

• Unsuitable for participation in the opinion of the principal investigator.

Sponsors & Collaborators

• Aqtual, Inc.: lead

Study Sites (1)

Arthritis and Osteoporosis Consultants of the Carolinas

Charlotte, North Carolina, 28207, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood \& processed plasma

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Diana Abdueva

  CEO

  STUDY DIRECTOR

Central Study Contacts

Aqtual Study Support

CONTACT

341-208-8569; studysupport@aqtual.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 10, 2023
• Study Start: June 29, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

US (1)