rheumatoid arthritis M05
Conditions
Interventions
Group 1: RA patients who receive an additional US examination by the US7 score to standard clinical care
Group 2: RA patients who (only) get a clinical examination by standard clinical care.
Sponsors
Charité Universitätsmedizin Berlin -Med. Klinik mit SP Rheumatologie und Klin. Immunologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: •Patients, at least 18 years of age, with currently active RA with or without re-ceiving DMARDs. Active disease is defined as DAS 28 > 3.2 and at least swollen joint count (SJC) = 3 and tender joint count (TJC) = 3 included in the 28 joint count. •Early RA (= 2 years from time of onset of arthritic symptoms)
Exclusion criteria
Exclusion criteria: •Patients receiving biologics •Patients with other chronic inflammatory articular disease or systemic autoimmune disease •Patients with erosions in conventional radiography taken less than 3 months before start of study •Patients participating in other studies •Any active infection, a history of recurrent clinically significant infection, a history of recurrent bacterial infections with encapsulated organisms (known Hepatitis B, C and HIV) •Primary or secondary immunodeficiency •History of cancer with curative treatment not longer than 5 years ago except basal-cell carcinoma of the skin that had been excised •Evidence of significant uncontrolled concomitant diseases or serious and / or uncontrolled diseases that are likely to interfere with the evaluation of the patient's safety and of the study outcome •Women lactating, pregnant, nursing or of childbearing potential with a positive pregnancy test or planned pregnancy. •Women of childbearing potential without adequate contraception (medically acceptable methods are contraceptive implant, contraceptive injection, intrauterine device (IUD), or oral contraceptives taken for at least 3 months, which the patient agrees to continue using during the study, or a double-barrier method which must consist of a combination of any of the following: diaphragma, cervical cap, comdom, or spermicide) •History of alcohol, drug or chemical abuse (defined as impaired / questionable reliability) as well as neurotic personality. •Neuropathy that can interfere with filling out the patient's questionnaires •History of a severe psychological illness or condition •Severe heart failure (New York Heart Association Class III and IV) or severe, uncontrolled cardiac disease •Women lactating, pregnant, nursing or child bearing potential with a positive pregnancy test or planned pregnancy. •Women of childbearing potential without adequate contraception (medically acceptable methods are contraceptive implant, contraceptive injection •no written consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare functional outcome in patients monitored according to standard care vs. patients additionally monitored by using US7 score. Functional outcome is measured by HAQ. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Compare disease activity in patients monitored according to standard care vs. patients additionally monitored by using US7 score. 2. Describe ultrasound driven changes in therapy, e.g. escalation of therapy in dose and regimen 3. Describe change, practicability and costs in patient management and resource allocation in clinic and outpatient clinics related to use of US7 score. 4. How does US7 score influence the therapeutic decisions? 5. Evaluate the clinician’s confidence with regards to his/her decision (on a visual analogue scale) before and after US examination. 6. Define criteria for imaging remission based on functional outcome and disease activity. | — |
Countries
Germany
Contacts
Public ContactGabriela Schmittat
Charité Universitätsmedizin Berlin - Med. Klinik mit SP Rheumatologie und Klin. Immunologie
Outcome results
None listed