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Rheumatoid ArthritisNCT02111057

Perioperative Flare in RA: Characterization of Clinical and Biological Features

An observational study of Rheumatoid Arthritis, run by Hospital for Special Surgery, New York at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Researchers at the Hospital for Special Surgery are trying to learn more about post-operative rheumatoid arthritis flare (RA). This study hopes to understand RA flare after total joint replacement surgery and what the result of flaring is for patients over the 6 weeks post operation. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Rheumatoid Arthritis
How many people
162 participants
Where
1 siteUnited States
Study dates
16 Oct 2013to 9 May 2017
Phase
Observational
Are there results?
None posted in the registry

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 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population will comprise of roughly 200 patients with Rheumatoid Arthritis undergoing a total joint replacement.

Who may be able to join

  • Age >18
  • Patients with Rheumatoid Arthritis undergoing total joint replacement surgery
  • Satisfy American College of Rheumatology(ACR)/European League Against Rheumatism(EULAR) 2010 classification criteria and/or the 1987 RA criteria (see below) and be diagnosed with RA
  • For control subjects: Have OA(Osteoarthritis), SLE(Systemic lupus erythematosus) or other inflammatory arthritis.

Who cannot join

  • Diagnosis of any other systemic rheumatic disease
  • Diagnosis of or crystalline arthropathy.
  • Unable to understand or read English.
  • Unable to follow the study protocol in a reliable manner.
  • Age < 18 or >75.
  • EXPLANATION OF CRITERIA:
Show all 40Show fewer
  • Rheumatoid arthritis 1987 criteria:
  • morning stiffness in and around joints lasting at least 1 hour before maximal improvement;
  • soft tissue swelling (arthritis) of 3 or more joint areas observed by a physician;
  • swelling (arthritis) of the proximal interphalangeal, metacarpophalangeal, or wrist joints;
  • symmetric swelling (arthritis);
  • rheumatoid nodules;
  • the presence of rheumatoid factor; and
  • radiographic erosions and/or periarticular osteopenia in hand and/or wrist joints.
  • Criteria 1 through 4 must have been present for at least 6 weeks. Rheumatoid arthritis is defined by the presence of 4 or more criteria, and no further qualifications (classic, definite, or probable) or list of exclusions are required.
  • ACR/EULAR 2010 criteria for the classification of RA:
  • Table 3. The 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis
  • Target population (Who should be tested?): Patients who
  • have at least 1 joint with definite clinical synovitis (swelling)*
  • with the synovitis not better explained by another disease
  • Classification criteria for RA (score-based algorithm: add score of categories A-D;
  • a score of ≥6/10 is needed for classification of a patient as having definite RA
  • Score
  • Joint involvement
  • 1 large joint 0
  • 2-10 large joints 1
  • 1-3 small joints (with or without involvement of large joints) 2
  • 4-10 small joints (with or without involvement of large joints) 3
  • >10 joints (at least 1 small joint) 5
  • Serology (at least 1 test result is needed for classification)
  • Negative RF and negative ACPA 0
  • Low-positive RF or low-positive ACPA 2
  • High-positive RF or high-positive ACPA 3
  • Acute-phase reactants (at least 1 test result is needed for classification)
  • Normal CRP and normal ESR 0
  • Abnormal CRP or abnormal ESR 1
  • Duration of symptoms
  • < 6 weeks 0
  • 6 weeks 1
  • The criteria are aimed at classification of newly presenting patients. In addition, patients with erosive disease typical of rheumatoid arthritis (RA) with a history compatible with prior fulfillment of the 2010 criteria should be classified as having RA. Patients with longstanding disease, including those whose disease is inactive (with or without treatment) who, based on retrospectively available data, have previously fulfilled the 2010 criteria should be classified as having RA.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hospital for Special Surgery

    New York, New York, 10021

Other trials in United States

About this study

Researchers at the Hospital for Special Surgery are trying to learn more about post-operative rheumatoid arthritis flare (RA). This study hopes to understand RA flare after total joint replacement surgery and what the result of flaring is for patients over the 6 weeks post operation.

Through this study we aim to describe rates, characteristics, and risk factors of RA flare within 6 weeks of total hip arthroplasty (THA) and total knee arthroplasty (TKA)

Read the detailed description

The condition to be studied is worsening (flare) of rheumatoid arthritis (RA) in patients who have undergone arthroplasty. RA patients were recruited prior to elective THA and TKA and prospectively followed. Clinicians evaluated RA clinical characteristics 0-2 weeks before and 6 weeks post surgery. Patients answered questions regarding disease activity including self-reported joint counts and flare status weekly for 6 weeks.

Keywords
Rheumatoid Arthritis, Total Hip Replacement, Flare, Perioperative Outcomes
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02111057
Study groupRoleWhat they receive
Perioperative RAPatients with Rheumatoid Arthritis undergoing a primary or secondary total hip replacement, between the ages of 18 and 90.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of RA Flare at 6 week post surgery

    The primary outcome is the rate of RA flare within 6 weeks of surgery as measured by the Outcome Measures in Rheumatoid Arthritis Clinical Trials(OMERACT) flare questionnaire. For comparison, the rate of RA flare at 1 week post surgery is measured.

    Measured: 6 weeks

Secondary outcomes (1)

  1. Severity and impact of flares 6 weeks and one year post arthroplasty, using the OMERACT PFQs

    The OMERACT PFQs include flare intensity, duration of flare, worsening of domains associated with flare (pain, fatigue, stiffness, patient reported tender and swollen joint count, difficulties with coping and participation).

    Measured: 6 weeks and one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2014 (estimated)
  2. Study start16 Oct 2013
  3. Primary completion9 May 2017
  4. Study completion9 May 2017

Resources

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
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02111057
Sponsor's protocol ID
2014-233
Status last verified
Oct 2019
First submitted
8 Apr 2014
Last updated
21 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by Hospital for Special Surgery, New York 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 40 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: finished, as of the sponsor's last update on 21 Oct 2019. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Rate of RA Flare at 6 week post surgery (time frame: 6 weeks). 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 NCT02111057.

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 21 Oct 2019.

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