Discovering the Antecedents of Rheumatoid Arthritis Flare

Active, not recruiting

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT02051114
• Lead Sponsor: Rockefeller University

Brief Summary

Longitudinal study of patients with rheumatoid arthritis comparing measures of disease activity with blood samples.

Detailed Description

80% of patients living with rheumatoid arthritis can expect fluctuations in their symptoms over time. Dramatic increases in disease activity are considered flare. This study will follow patients with increased risk for flare prospectively for one year. Serial questionnaires and disease activity scores will be compared to blood samples to better understand the molecular phenotype of rheumatoid arthritis flares.

Study Timeline

• Study First Submitted: 2014-01-29
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-31
• Study Start: 2014-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-27
• Primary Completion: 2030-02
• Study Completion: 2030-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

• 2010 criteria for Rheumatoid Arthritis
• Swelling of at least one joint and or elevated acute phase reactants
• Greater than or equal to 40 years old or less than or equal to 65 year old female sex
• cyclic citrullinated peptide antibody + in the past 12 months

Exclusion Criteria

• hemoglobin < 9
• white blood cell count < 3.5
• Diagnosis of any active malignancy within the last 3 years besides non-melanomatous skin cancer
• Diagnosis of diabetes and requires insulin
• HIV+, Hep B S Ag+, Hep C polymerase chain reaction +
• Untreated latent tuberculosis
• Diagnosis of any additional systemic autoimmune connective tissue disease
• Inability to reliably complete study requirements
• History, physical, social or laboratory findings suggestive of any other medical or psychological condition that would, in the opinion of the principal investigator, make the candidate ineligible for the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RNA transcripts that correlate with rheumatoid arthritis disease activity	1 year	Blood drawn at various times throughout one year will be correlated with fluctuations in RA disease activity.

Trial Locations

Locations (1)

The Rockefeller University Hospital; 🇺🇸 New York, New York, United States