EUCTR2006-003037-32-ES进行中（未招募）1 期
Estudio en fase IIIb, multicéntrico, comparado con grupo de control, doble ciego, aleatorizado y de dos brazos, con evaluaciones mensuales por resonancia magnética y biomarcadores para evaluar la eficacia, la seguridad y la tolerabilidad de Rebif New Formulation (IFN beta-1a) en pacientes con esclerosis múltiple remitente-recurrente.A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •· Males and females between 18 and 60 years of age
- •Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential, as defined by either:
- •oPost-menopausal or surgically sterile, or
- •oUsing a highly effective method of contraception for the duration of the study. A highly effective method of contraception is defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, IUDs, sexual abstinence or vasectomised partner*.
- •* Note for subjects using a hormonal contraceptive method: No formal drug interaction studies have been carried out with IFN-beta-1a or HSA free IFN-beta-1a. As interferons have been reported to exert an inhibitory activity on hepatic microsomal enzymes, it is unlikely that the clearance of oral contraceptives would increase and result in decreased efficacy. In over 10,000 patient-years of clinical trial experience with Rebif, there has never been any indication of an interaction with oral contraceptives.
- •· Have RRMS according to the revised McDonald criteria (2005)
- •· Have brain and/or spinal MRI with findings typical of MS
- •· Have disease duration for > 12 months
- •· Have disease activity characterized by at least one clinical event and one or more Gd-enhancing MRI lesions during the previous 6 months
- •· Have score less than equal to 5.5 on the EDSS
- •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
- •· Have received within 3 months prior to baseline any approved disease-modifying therapy for MS, cytokine or anti-cytokine therapy, intravenous immunoglobulin, any investigational drug, or experimental procedure
- •·Receive or have used anytime monoclonal antibodies, mitoxantrone, cytotoxic or immunosuppressive therapy (excluding systemic steroids and ACTH), or total lymphoid irradiation
- •· Have received within 30 days prior to baseline oral or systemic corticosteroids or ACTH
- •· Have known intolerance or any contraindication to both ibuprofren and to paracetamol/acetaminophen
- •·Have moderate to severe renal impairment
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