Abatacept reversing subclinical Inflammation as measured by MRI in ACPA positive Arthralgia

niversity Hospital Erlangen0 个研究点目标入组 98 人开始时间: 2014年5月26日最近更新: 2021年7月12日

适应症

试验速览

暂无简介。

•- Females and males aged =18 years at time of consent
•- ACPA (with or without RF)
•- Joint pain (hand, feet, knee, shoulder or elbow) present for at least 6 weeks prior to inclusion or in past history
•- Presence of synovitis (synovialitis or tenosynovitis) or osteitis in MRI of the dominant hand at baseline
•- Must understand and voluntarily sign an informed consent form including written consent for data protection
•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 65
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 33

•- Presence of arthritis in hand, feet, knee, shoulder or elbow joints defined as swelling
•- Current treatment with glucocorticoids conventional or biologic DMARDs
•- Any other autoimmune or inflammatory disease such as SLE, PSS, MCTD, SpA, Behcet disease, vasculitis or autoimmune hepatitis.
•- Any malignancy in the last 5 years
•- Chronic infection such as latent TB, (TB not adequately treated according to guidelines), or hepatitis B or C infection
•- Immunocompromised patients or patients known to be HIV positive
•- Uncontrolled severe concomitant disease
•- Pregnant or lactating females
•- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study

发起方

niversity Hospital Erlangen