EUCTR2007-000886-40-IT进行中（未招募）不适用
Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naive - DMARD early RA-patients. - LEADER
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
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** or female* over the age of 18 The inclusion of women* of childbearing must strictly respect the following recommendations:
- •To demonstrate they are not pregnant at the time of study entry, they agree to undergo urine pregnancy testing at inclusion visit. And safety follow up visit.
- •They are demonstrated not to be breast feeding at the time of study entry.
- •They agree to maintain adequate means of contraception throughout the study and for 24 months after the discontinuation of treatment or they undergo a wash out procedure
- •They agree not to be pregnant for 24 months after study treatment discontinuationor they undergo a wash out procedure.
- •Male** patients must consent to practice contraception during the study and to follow the wash out procedure if they wish to father a child after treatment discontinuation.
- •- Diagnosis of active rheumatoid arthritis in the previous 6 months (according to ACR guidelines)
- •- Must have active disease to be initiated by DMARDs
- •- Having given their informed consent
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Inclusion criteria:
- •- Male** or female* over the age of 18 The inclusion of women* of childbearing must strictly respect the following recommendations:
- •To demonstrate they are not pregnant at the time of study entry, they agree to undergo urine pregnancy testing at inclusion visit. And safety follow up visit.
- •They are demonstrated not to be breast feeding at the time of study entry.
- •They agree to maintain adequate means of contraception throughout the study and for 24 months after the discontinuation of treatment or they undergo a wash out procedure
- •They agree not to be pregnant for 24 months after study treatment discontinuationor they undergo a wash out procedure.
- •Male** patients must consent to practice contraception during the study and to follow the wash out procedure if they wish to father a child after treatment discontinuation.
- •- Diagnosis of active rheumatoid arthritis in the previous 6 months (according to ACR guidelines)
- •- Must have active disease to be initiated by DMARDs
- •- Having given their informed consent
- •- Patient presenting or having a history of other inflammatory joint disease.
- •- Patients with ongoing or previous Stevens- Johnson syndrome, toxic epidermal necrolysis or erythema multiforme.
- •- Patients with significantly impaired bone marrow function or significant anaemia, leucopenia or thrombocytopenia due to causes other than active rheumatoid arthritis
- •- Persistent infection or severe infection within 3 months before enrollment
- •- Uncontrolled hypertension, uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, terminal illness or other medical condition which, in the opinion of the investigator, would put the patient at risk to participate in the study
- •- Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
- •- Severe hypoproteinemia (e.g. in case of severe liver disease or nephrotic syndrome) with serum albumin < 3.0 g/dl
- •- Moderate or severe impairment of renal function, as shown by serum creatinine > 133 µmol/L (or 1.5 mg/dL).
- •- Patients with a history of recent and clinically significant drug or alcohol abuse
- •- Impairment of liver function or persisting ALT (SGPT) elevations of more than 2-fold the upper limit of normal
- •- Pregnancy
- •- Breastfeeding
- •- Women of childbearing potential, except if they fulfill all conditions described in the SmPC.
- •- Men wishing to father children during the course of the study or within the 24 months thereafter (or 3 months with the washout procedure)
- •- Patient with a congenital or acquired severe immuno-deficiency, a history of cancer or lymphoproliferative disease, or any patient who has received total lymphoid irradiation
- •- Known HIV positive status
- •- Known positive serology for hepatitis B or C
- •- Patients with hypersensitivity to any of the excipients in the tablets of leflunomide.
研究者
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Assessment of the early efficacy response rate of leflunomide according to the initial dosing regimen in the treatment of naïve-DMARD early RA-patients. - LEADERpatients with a diagnosis of early active rheumatoid arthritis in the previous 6 months, naïves of previous treatment by a DMARD and who need to be treated by a DMARDMedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritisEUCTR2007-000886-40-PTsanofi-aventis groupe200
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