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

niversitätsklinikum Erlangen0 个研究点目标入组 98 人开始时间: 2017年10月10日最近更新: 2023年10月23日

研究概览

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
•-Women of childbearing potential or men capable of fathering children must be using effective
•contraception during treatment with abatacept and up to 14 weeks after the last dose of abatacept treatment.
•- Must understand and voluntarily sign an informed consent form including written consent for data protection
•-Must be able to adhere to the study visit schedule and other protocol requirements
•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
•-Previous treatment with abatacept
•-Investigational study drug within 4 weeks (or 5 half lives, whichever is longer) prior to randomisation
•-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
•-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 or HIV-positive patients
•-Uncontrolled severe concomitant disease
•-Patients who are younger than 18 years or are incapable to understand the aim, importance and consequences of the study and to give legal informed consent (according to § 40 Abs. 4 and §
•41 Abs. 2 and Abs. 3 AMG).
•-Pregnant or lactating females
•-Patients who possibly are dependent on the Principal Investigator or Investigator (e.g. family members)

发起方

niversitätsklinikum Erlangen