EUCTR2004-000555-42-EE进行中（未招募）不适用
A randomized, double-blind, placebo-controlled, parallel group design study toevaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing thefrequency of relapses and delaying the accumulation of physical disability insubjects with multiple sclerosis with relapses.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,080
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
- •Subjects meeting all of the following criteria will be considered for enrollment into the study:
- •MS subjects, aged 18 to 55, who are ambulatory (EDSS of = 5.5)
- •Exhibiting a relapsing clinical course, with or without progression
- •Meeting McDonald’s criteria (Appendix A) for MS diagnosis
- •Experienced at least 1 relapses over the 1 years preceding the trial or at least 2 relapses over the 2 years preceding the trial
- •No relapse onset in the preceding 60 days prior to randomization
- •During the 4 weeks prior to randomization, subjects must have been clinically stable, without adrenocorticotrophic hormone (ACTH) or systemic steroid treatment
- •Signed main informed consent form and the informed consent from for HIV testing
- •Are the trial subjects under 18?
- •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)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects presenting with any of the following will not be included in the study:
- •Subjects with significantly impaired bone marrow function or significant anemia, leukopenia, or thrombocytopenia
- •Subjects with a congenital or acquired severe immunodeficiency, a history of cancer (except for basal or squamous cell skin lesions which have been surgically excised, with no evidence of metastasis), lymphoproliferative disease, or any subject who has received lymphoid irradiation
- •Human immunodeficiency virus (HIV) positive status ; Known history of active tuberculosis not adequately treated; Persistent significant or severe infection
- •Pregnancy ; Breastfeeding ; Subjects wishing to parent children during the course of the trial
- •Therapies that are disallowed (minimum of 4 weeks prior to randomization): phenytoin, warfarin, tolbutamide, St. John’s Wort, or cholestyramine
- •Subjects must not have used ACTH or systemic corticosteroids for 4 weeks prior to
- •randomization
- •Prior or concomitant use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate ; Prior use of natalizumab,
- •Prior use of interferons or cytokine therapy in the preceding 4 months
- •Prior use of glatiramer acetate therapy in the preceding 6 months
- •Prior use of intravenous immunoglobulins in the preceding 6 months
- •Prior use of any investigational drug in the preceding 6 months
- •Previous treatement with teriflunomde or leflunomide (ARAVA)
- •Contraindication for MRI, i.e., presence of pacemaker, metallic implants in high-risk areas (i.e., artificial heart valves, aneurysm/vessel clips), presence of metallic material (i.e., shrapnel) in high-risk areas, known history of allergy to any contrast medium, or history of claustrophobia that would prevent completion of all protocol-scheduled MRI. Hip implants are not contraindicated.
- •Liver function impairment or persisting elevations of SGPT/ALT, serum glutamic oxaloacetic transaminase (SGOT/AST), or direct bilirubin greater than 1.5-fold the upper limit of normal (ULN)
- •Persisting elevations of serum amylase or lipase greater than 2-fold the upper limit of normal
- •Known history of active hepatitis
- •Hypoproteinemia (e.g., in case of severe liver disease or nephrotic syndrome) with serum albumin <3.0 g/dL
- •Known history of chronic pancreatic disease or pancreatitis
- •Moderate to severe impairment of renal function, as shown by serum creatinine >133 µmol/L (or >1.5 mg/dL)
- •Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
- •Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the subject at risk by participating in the study
- •History of drug or alcohol abuse
- •Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
- •Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and known unlikelihood of completing the study
- •Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
研究者
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