Discovering the Antecedents of Rheumatoid Arthritis Flare

NCT ID: NCT02051114

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2030-02-28

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.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rockefeller University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dana E Orange, MD, MS

Role: PRINCIPAL_INVESTIGATOR

The Rockefeller University Hospital

Locations

The Rockefeller University Hospital

New York, New York, United States

Countries

United States

References

Orange DE, Yao V, Sawicka K, Fak J, Frank MO, Parveen S, Blachere NE, Hale C, Zhang F, Raychaudhuri S, Troyanskaya OG, Darnell RB. RNA Identification of PRIME Cells Predicting Rheumatoid Arthritis Flares. N Engl J Med. 2020 Jul 16;383(3):218-228. doi: 10.1056/NEJMoa2004114.

Reference Type: BACKGROUND

PMID: 32668112 (View on PubMed)

Brewer RC, Lanz TV, Hale CR, Sepich-Poore GD, Martino C, Swafford AD, Carroll TS, Kongpachith S, Blum LK, Elliott SE, Blachere NE, Parveen S, Fak J, Yao V, Troyanskaya O, Frank MO, Bloom MS, Jahanbani S, Gomez AM, Iyer R, Ramadoss NS, Sharpe O, Chandrasekaran S, Kelmenson LB, Wang Q, Wong H, Torres HL, Wiesen M, Graves DT, Deane KD, Holers VM, Knight R, Darnell RB, Robinson WH, Orange DE. Oral mucosal breaks trigger anti-citrullinated bacterial and human protein antibody responses in rheumatoid arthritis. Sci Transl Med. 2023 Feb 22;15(684):eabq8476. doi: 10.1126/scitranslmed.abq8476. Epub 2023 Feb 22.

Reference Type: BACKGROUND

PMID: 36812347 (View on PubMed)

Other Identifiers

DOR-0833

Identifier Type: -

Identifier Source: org_study_id