EUCTR2020-005518-16-DE进行中（未招募）1 期
3P study - Upadacitinib in Psoriatic Arthritis Pain Processing - U3P
niversitätsklinikum Erlangen0 个研究点目标入组 20 人开始时间: 2021年3月24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
- •Must understand and voluntarily sign an informed consent form including written consent for data protection
- •Adults aged = 18 years and < 65 years at time of consent
- •Patients fulfilling CASPAR criteria for PsA
- •Subjects must have active hand joint involvement (at least one swollen/tender joint)
- •Indication for systemic treatment
- •Subjects who failed to respond to or are intolerant to at least one csDMARD
- •Subjects who were not exposed to more than one bDMARD before; for bDMARDs the wash-out period should be at least three times the half-life of the bDMARD concerned.
- •Eligibility for the treatment with Upadacitinib according to the EU label
- •Glucocorticoids less than 10mg/day will be allowed
- •Male subjects (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with Females of Childbearing Potential (FCBP) while on study medication and for at least 28 days after taking the last dose of study medication.
- •Females of childbearing potential (FCBP) must have a negative urine pregnancy test at baseline and must be willing to use one highly-effective form of birth control when engaging in reproductive sexual activity while on study medication and for at least 28 days after taking the last dose of study medication.
- •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 13
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •- Prior exposure to any Janus kinase (JAK) inhibitor
- •- ANC < 1.000/mm3, ALC < 500/mm3 or hemoglobin < 8g/dl
- •- Any contraindication to perform MRI
- •- Anti-CCP- Antibody positivity
- •- Any other autoimmune or inflammatory disease such as SLE, PSS, MCTD, Behcet`s disease, vasculitis or autoimmune hepatitis.
- •- Malignancy risk factors (e.g. current malignancy or history of malignancy)
- •- Any severe active infection, e.g. hepatitis B or C, SARS-CoV 2 (COVID 19), or active tuberculosis as defined by a positive Quantiferon TB-test. If presence of latent tuberculosis is established then treatment according to local guidelines must have been initiated prior to enrollment.
- •- Have a known history of serious infections (e.g., hepatitis, pneumonia, or pyelonephritis) in the previous 3 months
- •- Immunocompromised patients
- •- Uncontrolled severe concomitant disease
- •- Pregnant or lactating females
- •- Known hypersensitivity to upadacitinib or any other drug components
- •- Requirement for immunization with live vaccine during the trial period or within 4 weeks preceding baseline
- •- History of venous thrombosis or pulmonary embolism, inherited coagulation disorder, planned major surgery, immobilisation
- •- History of atherosclerotic cardiovascular disease or other cardiovascular risk factors
- •- Current or past long-time smokers
- •- Clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, neurologic, gastrointestinal, immunologic, or other major diseases
- •- Evidence of severe renal dysfunction defined as: eGFR < 30 ml/min/1,73 m2 (calculated using the MDRD formula) at screening (Visit 1)
- •- Evidence of severe hepatic insufficiency defined as Child-Pugh score = 10 (C)
- •- Abnormal liver function tests such as GOT (AST), GPT (ALT), alkaline phosphatase or bilirubin. The investigator should be guided by the following criteria:
- •oGOT, GPT, alkaline phosphatase: any single parameter may not exceed 3x upper limit of normal (ULN). A single parameter elevated up to and including 3x ULN should be re-checked once more as soon as possible.
- •oTotal bilirubin: if total bilirubin concentration is increased above 2x ULN, total bilirubin should be differentiated into direct and indirect reacting bilirubin. In any case, serum bilirubin should not exceed the value of 1,6mg/dl (exemption: the diagnose of gilbert´s syndrome has already been established or based on higher levels of unconjugated bilirubin without either signs of other liver problems or red blood cell breakdown can be made)
- •- 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
- •- 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).
- •- Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results
- •- Patients who possibly are dependent on the Sponsor, the Principal Investigator or Investigator (e.g. family members)
- •- Have participated in this study before with respect to having received upadacitinib. Re-Screening is allowed once
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