ltrasound as biomarker for withdrawal of biological DMARDs in rheumatoid arthritis (RA-BioStop) - RABioStop

Med Uni Graz, Univ. Klinik Innere Medizin,Abt. Rheumatologie und Immunologie0 个研究点目标入组 110 人开始时间: 2012年5月15日最近更新: 2020年12月7日

适应症

试验速览

暂无简介。

•1.Male or female patients =18 years and <90 years of age
•2.Classification of RA according to the ACR-EULAR 2010 criteria
•3.Clinical remission according to ACR-EULAR remission criteria at time of inclusion and remission or low disease activity according to SDAI in the preceding 6 months
•4.Written informed consent
•5.Current treatment with a csDMARD plus a stable dose and administration interval (for at least 6 months) of a bDMARD
•6.No current corticosteroid treatment
•7.Stable dose of NSAIDs
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 75
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 35

•1.Current treatment with any investigational drug
•2.Current administration interval of the bDMARD of >11 weeks
•3.Complete destruction of any joint to be investigated by sonography
•4.Severe systemic (i.e. extraarticular) RA- manifestation
•5.Begin of arthritis before age of 17 years
•6.Planned surgery within the study period or history of surgery of any joint to be investigated clinically or by sonography
•7.Current severe medical illness requiring hospitalization
•8.Active infection or active malignancy
•9.Pregnancy or lactation
•10.Inability of the patient to follow the protocol
•11.Current treatment with Rituximab (MabThera®)

发起方

Med Uni Graz, Univ. Klinik Innere Medizin,Abt. Rheumatologie und Immunologie