2024-514026-23-00招募中2 期
JAK Inhibition in PReclinical Arthritis
Universitaetsklinikum Erlangen AöR1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年5月17日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of patients with development of arthritis at week 48
研究概览
简要总结
to evaluate the effect of JAK inhibition with baricitinib in preclinical stage of arthritis
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Female or male patients, at least 18 and at most 64 years of age
- •Clinical: no arthritis in 76/78 joint count
- •Imaging: ≥ 1 B-Mode or Power Doppler signal with ultrasound at one of the 76/78 joints of flexor/extensor tendons of hand or feet
- •Autoantibodies (2 different autoantibodies are compulsory, one of them anti-CCP antibodies): o Anti-CCP antibody positivity at screening o Anti-modified antibodies: citrullinated vimentin (citVIM); citrullinated a-enolase (citENO); citrullinated fibrinogen alpha (citFIBa); citrullinated fibrinogen beta (citFIBb); carbamylated vimentin (carVIM), ornithine acetylated vimentin (ac-orn VIM) and lysine acetylated Vimentin (ac-lys VIM) or RF
- •Genetics: HLA status with positive risk allele for RA such as HLA DRB1*01,*02,*03,*04...*015
- •Non-pregnant, non-breastfeeding female patients
排除标准
- •Clinically apparent arthritis (76/78 joint count)
- •Any known VTE risk factor (e.g. previous VTE/LE or inherited coagulation disorder)
- •Fulfilment of ACR/EULAR 2010 Classification Criteria for RA
- •Any previous therapy with bDMARD/tsDMARD/cDMARD
- •Any malignancy risk factor (e.g. current malignancy or history of malignancy)
- •Any active, chronic or recurrent infection
- •Any uncontrolled comorbidity
- •Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process, obtained within 3 months or according to local guidelines prior to screening and evaluated by a qualified physician
- •Contraindication for baricitinib treatment according to its SmPC
- •Any pre-existing condition that constitutes a risk factor for major adverse cardiovascular events (e.g. history of stroke, coronary heart disease, myocardial infarction, current or past long-time smoker)
结局指标
主要结局
Number of patients with development of arthritis at week 48
Number of patients with development of arthritis at week 48
次要结局
- Number of patients with development of arthritis at week 24
- Fulfillment of the ACR/EULAR 2010 RA classification criteria
- Ultrasound: number of patients without signs of PD synovitis or PD tenosynovitis at week 24 and week 48 compared to baseline and compared within both groups
- Safety: (S)AE
- Subjective (SACRAH, sMHQ) and objective (moberg pick up test (MPUT)) hand function
- Change in anti CCP2 antibody levels (RE/ml)
研究者
Sara Bayat
Scientific
Universitaetsklinikum Erlangen AöR
研究点 (1)
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