Rheumatoid ArthritisNCT02051114
Discovering the Antecedents of Rheumatoid Arthritis Flare
An observational study of Rheumatoid Arthritis, run by Rockefeller University at 1 site in United States.
Trial summary
Longitudinal study of patients with rheumatoid arthritis comparing measures of disease activity with blood samples. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Feb 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Rheumatoid Arthritis
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Rockefeller University Hospital
New York, New York, 10065
About this study
Longitudinal study of patients with rheumatoid arthritis comparing measures of disease activity with blood samples.
Read the 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
- Keywords
- Rheumatoid arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
RNA transcripts that correlate with rheumatoid arthritis disease activity
Blood drawn at various times throughout one year will be correlated with fluctuations in RA disease activity.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dana E Orange, MD, MS, Principal investigator, The Rockefeller University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051114
- Sponsor's protocol ID
- DOR-0833
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2014
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32668112Brewer 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.
PubMed 36812347
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discovering the Antecedents of Rheumatoid Arthritis Flare
- ClinicalTrials.gov ID
- NCT02051114
- Acronym / sponsor ID
- DOR-0833
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid arthritis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 31 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rheumatoid Arthritis
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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 +
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Background: PubMed 32668112Orange 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.
- Background: PubMed 36812347Brewer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dana E Orange, MD, MS principal investigator
The Rockefeller University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Rockefeller University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RNA transcripts that correlate with rheumatoid arthritis disease activity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02051114, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.