Evaluation of Pharmacokinetic Parameters of "Diprospan"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Betamethasone concentration in urine
研究概览
简要总结
Evaluation of pharmacokinetic parameters of diprospan in long term when administered systemically in patients in routine medical practice.
Applied research project.
Design: open-comparative prospective cohort study.
Two groups of subjects:
- patients who are receiving diprospan in standard therapy of their existing disease, or multiple times, but following the introduction of diprospan is planned no earlier than 28 days after the first,
- control group of subjects for the study of pharmacokinetic parameters diprospan and its metabolites.
Objectives of the study: to evaluate the pharmacokinetic parameters of Diprospan in the long term when administered systemically in patients in routine practice.
详细描述
Design: Open-comparative prospective cohort study.
The study population: two groups of subjects
- first group: patients who are receiving diprospan in standard therapy of their existing disease, or multiple times, but following the introduction of diprospan is planned no earlier than 28 days after the first administration.
- second group: the control group of subjects for the study of pharmacokinetic parameters diprospan and its metabolites.
Intramuscular injection diprospan (suspension for injection) at a dose of 1 ml (7 mg) once.
Main objective of the study: to evaluate pharmacokinetic parameters of Diprospan in the long term when administered systemically in patients in routine practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed a voluntary informed consent form,
- •Patients of both sexes aged 18 to 35 years old Caucasian,
- •Verified diagnosis of rheumatoid arthritis according to criteria ACR \ EULAR 2010 or ankylosing spondylitis (axial spondyloarthritis) ASAS criteria for 2009 based on the data a detailed medical history, a standard clinical, laboratory and instrumental methods of examination,
- •The presence of signs of active inflammation according to standard valuation techniques (for rheumatoid arthritis or DAS28 ≥3.2 CDAI≥10; for ankylosing spondylitis or BASDAI≥2.0 ASDAS≥1.3),
- •If the patient gets authorized for use in the study antirheumatic drugs (except glucocorticoids other) for treatment of the underlying disease, they should be applied in stable doses for at least six weeks before the screening visit.
- •BMI should be in the range of 18.0 to 30.0 kg / m 2 ,
- •Consent to use adequate methods of contraception to patients during the study period.
排除标准
- •Allergic history,
- •Drug intolerance, hypersensitivity to any of the components "Diprospan" drug,
- •Severe chronic cardiovascular, bronchopulmonary, endocrine and nervous systems (including mental) and diseases of the gastrointestinal tract (GIT), liver, kidney, blood, surgical procedures on the gastrointestinal tract (except appendectomy)
- •Acute infectious, non-infectious and allergic diseases in less than 4 weeks prior to visit 1,
- •A positive blood test for HIV, syphilis, hepatitis B and C,
- •Systolic blood pressure measured at rest after 5 minutes of exposure in the "sitting" position, below 100 mm Hg. or above 140 mm Hg and / or diastolic blood pressure below 60 mm Hg or above 90 mm Hg,
- •Heart rate below 40 beats / min,
- •Hemoglobin <90 g / l (9 g / dl), or hematocrit less than 30%,
- •White blood cells <3.0 x 10 9 / L,
- •Absolute neutrophil count (ANC) <1.0 x 10 / L,
- •Serum creatinine more than 0.132 mmol / L,
- •Increased ALT and / or AST 1.5 upper limit of normal,
- •Clinically significant (in the opinion of the investigator) ECG changes,
- •The use of systemic or local corticosteroids for the treatment of the underlying disease for the last 12 weeks before the screening visit,
- •Taking any medications, in addition to permissible under study
- •Plasmapheresis in less than 14 days prior to study entry,
- •Participation in a clinical trial of an unregistered in the Russian Federation of a drug or device for less than 3 months prior to the study,
- •The inability or unwillingness of the patient to comply with the conditions of the study program,
- •Any reason for that, according to the researcher, will prevent the participation of the patient in the study,
- •Pregnant or lactating women (all women should have a negative pregnancy test on the day of screening).
研究组 & 干预措施
Patients receiving diprospan
Patients who are receiving diprospan in standard therapy of their existing disease, or multiple times, but following the introduction of diprospan is planned no earlier than 28 days after the first administration.
干预措施: Diprospan (Drug)
结局指标
主要结局
Betamethasone concentration in urine
时间窗: Day 28
Quantitative determination of study drug (betamethasone) in human urine should be conducted sensitive, selective and precise method using high performance liquid chromatography with tandem mass selective detection (HPLC-MS / MS) with a detection mode permits fragment ions not more R \<70K. laboratory analytical method should be developed for the measurement of betamethasone with the definition of the limit of not less than 7.5 ng / mL.
次要结局
- Physician's assessment of disease activity(Day 28)
- Articular status (pain)(Day 28)
- Simple disease activity index SDAI(Day 28)
- Clinical disease activity index CDAI(Day 28)
- Articular status (swelling)(Day 28)
- Disease activity score DAS28(Day 28)