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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1410 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-29

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Adults diagnosed with RA

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

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diana Abdueva

Role: STUDY_DIRECTOR

CEO

Locations

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Arthritis and Osteoporosis Consultants of the Carolinas

Charlotte, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Aqtual Study Support

Role: CONTACT

[email protected]

341-208-8569

Facility Contacts

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Coordinator

Role: primary

Other Identifiers

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PRIMA - 102

Identifier Type: -

Identifier Source: org_study_id