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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
United States
North Carolina
Arthritis and Osteoporosis Consultants of the Carolinas
RECRUITING
Charlotte
Contact Information
Primary
Aqtual Study Support
studysupport@aqtual.com
341-208-8569
Time Frame
Start Date: 2023-06-29
Estimated Completion Date: 2025-12
Participants
Target number of participants: 1410
Treatments
Adults diagnosed with RA
Adults diagnosed with RA who are planning to initiate a new bDMARD +/- csDMARD or tsDMARD +/- csDMARD treatment
Related Therapeutic Areas
Sponsors
Leads: Aqtual, Inc.

This content was sourced from clinicaltrials.gov

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