EUCTR2013-004176-35-SE进行中（未招募）不适用
A randomized, double blind, placebo-controlled, proof-of-concept study of FP187 in patients with mild to moderate Psoriatic Arthritis
Department of Rheumatology, Skåne University Hospital0 个研究点开始时间: 2014年1月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •male and female of at least 18 years of age;
- •documented clinical diagnosis of mild to moderate psoriatic arthritis (according to the Classification of Psoriatic Arthritis (CASPAR) criteria) for at least 3 months prior to study start;
- •active psoriatic arthritis at the time of study entrance with at least 2 tender and 2 swollen joints at Visit 1;
- •signed informed consent;
- •willingness and ability to comply with study procedures;
- •besides psoriatic arthritis, patient must be in good general health in the opinion of the Investigator, as determined by medical history, physical examination, vital signs (systolic and diastolic blood pressure [upper limit 160/95] pulse rate [between 50 and 100]), electrocardiogram (ECG), and clinical laboratory parameters (hematology, biochemistry and urinalysis)). Minor deviations of laboratory values from the normal range may be accepted, if judged by the Investigator to have no clinical relevance;
- •if the patients are using methotrexate, they should be on a stable dose not exceeding 20 mg/week for at least 90 days prior to study entrance, and should present no serious toxic side effects attributable to methotrexate;
- •females of childbearing potential must be either surgically sterile (hysterectomy or tubal ligation) or use a highly effective (failure rate <1%) medically accepted contraceptive method during the trial as well as one month after trial is finished such as:
- •-Systemic contraceptive : (oral (except low-dose gestagen [lynestrenol and norestisteron], injectable or implanted hormonal contraceptives(oral, implant, injection);
- •-Intrauterine device (IUD) inserted for at least one month prior to study entrance;
- •-Intrauterine system (e.g., progestin-releasing coil);
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •female patients who are pregnant or breast-feeding or planning to become pregnant during the entire trial period as well as male patients planning pregnancy with their partner during the entire trial period or practice unprotected sexual relationship during the entire trial period;
- •male patients planning pregnancy with their partner during the entire trial period, or practicing unprotected sexual relationship during the entire trial period;
- •known allergy to any of the constituents of the products being tested;
- •known immunosuppressive diseases (e.g., AIDS/HIV);
- •known history of latent or active granulomatous infection, including tuberculosis, histoplasmosis, or coccidioidomycosis, prior to study entrance;
- •presence of another inflammatory disease, including but not limited to rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, or Lyme disease;
- •presence of chronic widespread pain syndrome;
- •patients with pustular forms of psoriasis, erythrodermic or guttate psoriasis;
- •patients with another non-psoriatic arthropathy (e.g., osteoarthritis);
- •presence of another serious or progressive disease including skin malignancies;
- •presence or history of any malignancy, with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin that has been treated with no evidence of recurrence within 5 years of study entrance, or cervical carcinoma in situ that has been treated with no evidence of recurrence;
- •use at any time of any DMARD such as etanercept, adalimumab, golumumab, certolizumab pegol, or infliximab. Patients receiving methotrexate are allowed to participate to the Study if they have receive a stable dose not exceeding 20 mg/week for at least 90 days prior to study entrance, and do not present any serious toxic side effects attributable to methotrexate;
- •received corticosteroid joint injections within 12 weeks prior to study entrance;
- •use of any DMF containing products during the past 12 weeks prior to study entrance;
- •use of any retinoid treatments, other immunosuppressive treatments, cytostatics or drugs with known harmful effects on the kidneys within the last 3 month of study entrance, also if currently kidney functions are normal;
- •use of cyclosporine, corticosteroids or psoralen + UVA (PUVA) treatment within 4 weeks of Visit 1;
- •presence of on-going stomach or intestinal problems (e.g., gastritis or peptic ulcer);
- •liver enzyme results (AST, ALT) > 2 x upper normal limit (ULN) or ?-GT results > 2.5 x ULN;
- •estimated Creatinine Clearance (Cockcroft-Gault) < 60 mL/min;
- •presence of leucopenia (leukocyte count < 3.5x109/L), eosinophilia (count > 750/µL), or lymphocytopenia (count < 1.02 x109/L);
- •presence of protein detected by urine stick test at Screening and/or Baseline, and confirmed in a subsequent complete urinalysis;
- •participation in another clinical trial during the last two months preceding study entrance, or participation in a trial with another psoriatic arthritis treatment within 6 months prior to study entrance;
- •patients who are involved in the organization of the clinical investigation or are in any way dependent on the Investigator.
研究者
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