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Rheumatoid Arthritis | The Predictive Value of Ultrasound in Early Rheumatoid Arthritis

Rheumatoid Arthritis research study

What is the primary objective of this study?

Rheumatoid arthritis a chronic and progressive inflammatory disease characterized by synovial membrane inflammation, possibly leading to destruction of joints. To start early with a combination therapy results in a better outcome for patients. Using ultrasonography it is possible to detect clinically and radiographically absent synovitis and erosions. However, it is unclear whether or not these findings have predictive value in these patients regarding disease activity or radiographical progression.

Who is eligible to participate?

Inclusion Criteria: - Newly diagnosed rheumatoid arthritis patients, diagnosed according to the American College of Rheumatology (ACR) 1987-criteria - Naïve for Disease Modifying Anti Rheumatic Drugs (DMARDs), biologicals and glucocorticoids. - Starting with treatment with a potent anti-rheumaticum. E.g. methotrexate (MTX), biologicals or glucocorticoids. Exclusion Criteria: - Contra-indications for MTX, biologicals or glucocorticoids. - Insufficient ability to read and write in Dutch - Personality disorders that limit the participation in the study

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Rheumatoid Arthritis

Predictive Value of Ultrasound in Early Rheumatoid Arthritis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Rheumatoid Arthritis, ultrasound, persistence disease activityPatients diagnosed with early Rheumatoid Arthritis will be assessed three times in one year with ultrasound to evaluate the predictive value of ultrasound.

Study Status

Completed

Start Date: June 2010

Completed Date: July 2013

Phase:

Type: Observational

Design:

Primary Outcome: Persistence of active disease after one year, defined as a Disease Activity Score of 44 joints (DAS44) > 3.4

Secondary Outcome: Change in Sharp vd Heijde score during the year of inclusion

Study sponsors, principal investigator, and references

Principal Investigator: Jolanda J. Luime, PhD

Lead Sponsor: Erasmus Medical Center

Collaborator: Maasstad Hospital

More information:https://clinicaltrials.gov/show/NCT01752309

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