ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 87 for:    Recruiting Studies | Rheumatoid Arthritis | United States
Previous Study | Return to List | Next Study

Discovering the Antecedents of Rheumatoid Arthritis Flare

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02051114
Recruitment Status : Recruiting
First Posted : January 31, 2014
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Dana Orange, Rockefeller University

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

Condition or disease
Rheumatoid Arthritis

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 Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Discovering the Antecedents of Rheumatoid Arthritis Flare
Study Start Date : February 2014
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. RNA transcripts that correlate with rheumatoid arthritis disease activity [ Time Frame: 1 year ]
    Blood drawn at various times throughout one year will be correlated with fluctuations in RA disease activity.


Biospecimen Retention:   Samples Without DNA
Blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Rheumatoid Arthritis
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02051114


Contacts
Contact: Recruitment Specialist 1-800-782-2737 RUcares@rockefeller.edu

Locations
United States, New York
The Rockefeller University Hospital Recruiting
New York, New York, United States, 10065
Principal Investigator: Dana E Orange, MD, MS         
Sponsors and Collaborators
Rockefeller University
Investigators
Principal Investigator: Dana E Orange, MD, MS The Rockefeller University Hospital

Responsible Party: Dana Orange, Instructor in Clinical Investigation, Rockefeller University
ClinicalTrials.gov Identifier: NCT02051114     History of Changes
Other Study ID Numbers: DOR-0833
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017

Keywords provided by Dana Orange, Rockefeller University:
Rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases