Prospective multicenter Study to evaluate the Effect of tight and systematic monitoring by Ultrasound on Therapy and Outcome in Patients with early rheumatoid Arthritis - US Impera Study

Charité Universitätsmedizin Berlin -Med. Klinik mit SP Rheumatologie und Klin. Immunologie0 sites453 target enrollmentJune 1, 2016

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: rheumatoid arthritis
Sponsor: Charité Universitätsmedizin Berlin -Med. Klinik mit SP Rheumatologie und Klin. Immunologie
Enrollment: 453
Status: Completed
Last Updated: last year

No summary available.

Registry

who.int

Start Date

June 1, 2016

End Date

February 14, 2013

Last Updated

last year

Study Type

Observational

Sex

All

Sponsor

Charité Universitätsmedizin Berlin -Med. Klinik mit SP Rheumatologie und Klin. Immunologie

•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)

•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)