Perioperative Flare in RA: Characterization of Clinical and Biological Features

Rheumatoid Arthritis Clinical Trial

Official title:

Perioperative Flare in RA: Characterization of Clinical and Biological Features

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02111057
• Other study ID #: 2014-233
• Status: Completed
• Start date: October 16, 2013
• Est. completion date: May 9, 2017

Study information

• Verified date: October 2019
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: May 9, 2017
• Est. primary completion date: May 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age >18

2. Patients with Rheumatoid Arthritis undergoing total joint replacement surgery

3. 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

4. For control subjects: Have OA(Osteoarthritis), SLE(Systemic lupus erythematosus) or other inflammatory arthritis.

Exclusion Criteria:

1. Diagnosis of any other systemic rheumatic disease

2. Diagnosis of or crystalline arthropathy.

3. Unable to understand or read English.

4. Unable to follow the study protocol in a reliable manner.

5. Age < 18 or >75.

EXPLANATION OF CRITERIA:

Rheumatoid arthritis 1987 criteria:

1. morning stiffness in and around joints lasting at least 1 hour before maximal improvement;

2. soft tissue swelling (arthritis) of 3 or more joint areas observed by a physician;

3. swelling (arthritis) of the proximal interphalangeal, metacarpophalangeal, or wrist joints;

4. symmetric swelling (arthritis);

5. rheumatoid nodules;

6. the presence of rheumatoid factor; and

7. 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

1. have at least 1 joint with definite clinical synovitis (swelling)*

2. 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

A. 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

B. 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

C. Acute-phase reactants (at least 1 test result is needed for classification)

Normal CRP and normal ESR 0

Abnormal CRP or abnormal ESR 1

D. 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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks
Secondary	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).	6 weeks and one year

External Links

•   Hospital for Special Surgery
•   Principal Investigator, Susan Goodman MD