EUCTR2017-001368-40-ES进行中（未招募）1 期
Open clinical study to assess long-term efficacy and safety of dimethyl fumarate in adults with moderate to severe chronic plaque psoriasis in real practice (DIMESKIN 1 Trial) - DIMESKIN 1
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 282
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
- •(1) Signed and personally dated written informed consent
- •(2) Male / female
- •(3) Aged 18 years or older
- •(4) With a diagnosis of chronic plaque psoriasis for at least 6 months before enrolment in the study
- •(5) With the severity of psoriasis defined as moderate to severe, as reflected in meeting one of the following criteria:
- •- PASI = 10
- •- BSA = 10 + PASI = 5
- •- DLQI = 10 + PASI = 5
- •(6) With general good health, or a stable medical condition not considered likely to interfere with the conduct of the clinical study, as determined by the investigator based upon results of medical history, laboratory results and physical examination
- •(7) Candidate for systemic treatment.
- •(8) With a complete record of at least 6 months of other previous topical and systemic treatments, if any.
- •(9) Adhering to the following wash-out periods:
- •Topical treatment: Wash-out Period: 2 weeks: Corticosteroids,Vitamin A analogues, Vitamin D analoguess, Tar, Salicylic acid preparations.
- •Systemic treatment: Wash-out Period: 4 weeks: Conventional systemic antipsoriatic drugs (methotrexate, cyclosporine, acitretin), apremilast and phototherapy.
- •(10)For females of child-bearing potential: a negative serum pregnancy test at screening and willing to use highly effective methods of birth control during the study period.
- •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 250
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1. For females: pregnant or willing to be pregnant or breastfeeding
- •2. With a diagnosis of guttate, erythrodermic or pustular psoriasis
- •3. With a haematological abnormality as white blood cell (WBC) count 3,0 x 10^9/l or lymphocyte count <1,0 x 10^9/l
- •4. With a history of malignancies except for non-melanoma skin cancer
- •5. Suffering from significant gastrointestinal problems (ulcers, diarrhoea, etc.)
- •6. Known to have severe renal impairment (creatinine clearance <30 mL/min, estimated glomerular filtration rate (eGFR) using CKD-EPI Creatinine Equation or significant proteinuria (3+ or higher) measured by dipstick at screening.
- •7. Were detected to have abnormal liver enzymes:
- •a) if an enzyme was >3x the upper limit of the normal range (ULN): aspartate amino transferase (AST; serum glutamic oxaloacetic transaminase [SGOT]), alanine amino transferase (ALT; serum glutamic pyruvic transaminase [SGPT]), gamma-glutamyl-transferase (gamma-GT), alkaline phosphatase (ALP)
- •b) if bilirubin was >2x ULN, for the other liver enzymes >2x ULN was exclusionary
- •8. With active infectious disease
- •9. With a history of alcohol or drug abuse
- •10. Known suffering from any other immunosuppressive disease or treated with any immunosuppressive drug
- •11. Known to be hypersensitive to ingredients of DMF
- •12. Known to be intolerant to lactose
- •13. Previously enrolled in this study or participating in any drug investigational trial within the 30 days (or five half-lives whichever is longer) prior to enrolment.
- •14. Previously treated with biologic drug with antipsoriatic activity
- •15. Unable to comply with the requirements of the study or who in the opinion of the investigator should not have participated in the study
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