Clinical Trial Finder

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05936970
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Aqtual, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Diana Abdueva
Principal Investigator Affiliation CEO
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Rheumatoid Arthritis
Additional Details

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.

Arms & Interventions

Arms

: Adults diagnosed with RA

Adults diagnosed with RA and with inadequate response or intolerance to a DMARD and who are planning to initiate a new bDMARD +/- csDMARD or tsDMARD +/- csDMARD treatment

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Charlotte, North Carolina

Status

Recruiting

Address

Arthritis and Osteoporosis Consultants of the Carolinas

Charlotte, North Carolina, 28207

Site Contact

Coordinator

[email protected]

341-208-8581

Powered By