EUCTR2017-002793-39-DE进行中（未招募）1 期
Abatacept Bone Effects in Psoriatic Arthritis with Bone Biomarker – ABEPSA_BB - ABEPSA_BB
niversitätsklinikum Erlangen0 个研究点目标入组 20 人开始时间: 2017年12月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Females and males aged = 18 years at time of consent
- •Classification of Psoriasis arthritis according to CASPAR criteria
- •Active arthritis with more than 2 swollen and tender joints
- •>=1 erosion at the Metacarpophalangeal Joint 2 or 3 detected by Imaging (Hand MRI or HR PQCT)
- •cDMARD inadequate responders (e.g. methotrexate failure or any other failure to cDMARD therapy) or cDMARD intolerance; Exception: in subjects who were previously treated with tsDMARD (e.g. Apremilast) or bDMARD (e.g. Guselkumab) due to their Psoriasis Involvement as a first line therapy, cDMARD Treatment failure/intolerance is not a mandatory requirement.
- •Subjects who have been previously been treated with bDMARD or tsDMARD will be allowed entry into study after an appropriate wash-out period prior to baseline:
- •- Adalimumab: 6 weeks or longer (average half-life 2 weeks)
- •- Certolizumab: 6 weeks or longer (half-life approx. 14 days)
- •- Etanercept: 3 weeks or longer (half-life approx. 70 hours)
- •- Golimumab: 6 weeks or longer (half-life 12 + 3 days)
- •- Infliximab: 7 weeks or longer (half-life 8-9,5 days)
- •- Secukinumab: 12 weeks or longer (average half-life 27 days)
- •- Ustekinumab: 12 weeks or longer (half life up to 32 days)
- •- Guselkumab: 6 weeks or longer (half life up to 18 days)
- •- Tofacitinib: 1 week or longer (half-life 3 hours)
- •- Apremilast: 1 week or longer (half life up to 9 hours)
- •- Baricitinib: 1 week or longer (half life up to 12,5 hours)
- •- Upadacitinib: 1 week or longer (half life upp to 14 hours)
- •- For other bDMARD not mentioned above the wash-out period should be at least three times the half-life of the bDMARD concerned.
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Indication for systemic treatment for the skin other than DMARD`s
- •Any contraindications for abatacept
- •Current Treatment with bDMARDs
- •Previous exposure to abatacept
- •Investigational study drug within 4 weeks (or 5 halflifes (one half life is 14,3 days), whichever is longer) prior to enrolment
- •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)
研究者
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