EUCTR2015-005777-20-DE进行中（未招募）1 期
Impact of concomitant Methotrexate on efficacy, safety and adherence of Ustekinumab-treatment in patients with active Psoriatic Arthritis (MUST-Study)
Fraunhofer Gesellschaft for its Institute Fraunhofer Institute for Translational Medicine and Pharmacology ITMP0 个研究点目标入组 196 人开始时间: 2016年9月20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
- 196
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
- •Patients with active psoriatic arthritis who are naïve to UST will be stratified to either without MTX-therapy or on MTX-treatment for at least 12 weeks prior to screening.
- •Active PsA is defined as
- •TJC =4 and SJC =4 (66/68 joint count) and
- •DAS28 = 3,2
- •PsA according to CASPAR criteria
- •Presence of chest x-ray without signs of active or latent infection (esp. for tuberculosis) within the last 3 months prior to screening
- •Permitted pre-treatment of PsA with up to three biologic-agents, whereupon only one biologic agent must be withdrawn due to inadequate response.
- •For MTX naïve patients: Previous use of NSAID
- •at least age of 18 years
- •Written informed consent obtained prior to the initiation of any protocol-required procedures
- •Compliance to study procedures and study protocol
- •Inclusion criteria related to MTX
- •For the group on MTX: Patients must have MTX treatment (dosage =15mg/week) for at least 12 weeks prior to screening and stable MTX dosages of 15mg once weekly for at least 4 weeks prior to screening
- •Compliance of intake of MTX must be documented
- •For the group without MTX therapy: patients must be eligible for MTX treatment (according to SmPC) and have not failed prior MTX treatment for the treatment of PsA
- •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 98
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 98
排除标准
- •previous use of UST or any other anti-IL23 agent
- •Exclusion criteria related to IMP
- •according to SmPC
- •For the group without MTX: Inadequate Response to prior MTX-treatment for Psoriatic Arthritis
- •Exclusion criteria related to general health:
- •previous B-cell depleting therapy
- •Patients with other chronic inflammatory articular disease or systemic autoimmune disease with musculoskeletal symptoms
- •Patients with active Tb
- •Patients with latent Tb, measured by Interferon gamma release assay, that are not pre-treated for at least 1 months and planned to be treated 9 months in total with INH once a day according to local guidelines
- •Any active infection, a history of recurrent clinically significant infection, a history of recurrent bacterial infections with encapsulated organisms
- •Primary or secondary immunodeficiency
- •History of cancer with curative treatment not longer than 5 years ago except basal-cell carcinoma of the skin that had been excised
- •Evidence of significant uncontrolled concomitant diseases or serious and/or uncontrolled diseases that are likely to interfere with the evaluation of the patient's safety and of the study outcome
- •History of a severe psychological illness or condition
- •Known hypersensitivity to any component of the product
- •Women lactating, pregnant, nursing or of childbearing potential with a positive pregnancy test
- •Males or females of reproductive potential not willing to use effective contraception (e.g. contraceptive pill, IUD, physical barrier)
- •Alcohol, drug or chemical abuse
- •Exclusion criteria related to prior treatments:
- •Previous DMARD therapy other than MTX at least for the last 28 days prior to screening due to washout time of different DMARD therapies (including Leflunomide etc.)
- •Previous immunosuppressive biologic therapy at least for the last 60 days prior to screening due to washout time of different immunosuppressive biologic therapies (including antiTNF etc.)
- •current participation in another interventional clinical trial
- •Exclusion criteria related to laboratory:
- •Haemoglobin < 8.5 g / dl
- •Neutrophil counts < 1.500 / µl
- •Platelet count < 75.000 / µl
- •Lower than 1 x 1000 / µl lymphopenia for more than three months prior to inclusion.
- •Serum creatinine > 1.4 mg / dl for women or 1.6 mg / dl for men
- •AST or ALT > 2.5 time upper limit of norm
- •Exclusion criteria related to formal aspects:
- •Underage or incapable patients
研究者
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