RECRUITING

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 Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-06-29
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05936970

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to understand and provide written informed consent.
  2. * Male or female ≥18 years of age at enrollment.
  3. * Diagnosis of Rheumatoid Arthritis at the time of enrollment.
  4. * Prior treatment with at least 1 csDMARD, bDMARD, or tsDMARD
  5. * Planning to initiate a new bDMARD (+/- csDMARD) or tsDMARD (+/- csDMARD), within 1 month after enrollment.
  6. * 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.
  1. * Unsuitable for participation in the opinion of the principal investigator.

Contacts and Locations

Study Contact

Aqtual Study Support
CONTACT
341-208-8569
studysupport@aqtual.com

Principal Investigator

Diana Abdueva
STUDY_DIRECTOR
CEO

Study Locations (Sites)

Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte, North Carolina, 28207
United States

Collaborators and Investigators

Sponsor: Aqtual, Inc.

  • Diana Abdueva, STUDY_DIRECTOR, CEO

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-29
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-06-29
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Rheumatoid Arthritis