EUCTR2011-003484-30-ES进行中（未招募）1 期
A multi-centre, open-label, non-randomised, parallel group clinical trial to assess the efficacy of fingolimod in naïve patients versus fingolimod in patients previously treated with interferons or glatiramer acetate, based on the presence of relapses in patients with relapsing-remitting multiple sclerosis. - Earlims
ovartis Farmacéutica S.A.0 个研究点目标入组 432 人开始时间: 2012年4月12日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 432
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
- •1.Patients 18 to 50 years of age, inclusive.
- •2.Patients diagnosed with multiple sclerosis, according to the revised McDonald criteria of 2010,1 with a relapsing-remitting course,2 and with at least 9 T2 lesions consistent with the disease.
- •3.Patients with a duration greater than or equal to one year and less than or equal to five years.
- •4.Patients who have had at least two relapses in the past two years.
- •5.Patients with an EDSS score3 between 0 and 3.5, inclusive.
- •6.Patients
- •a.Naïve: patients who have never been treated with a DMT
- •b.Previously treated with first-line DMT patients who have been treated with a first-line DMT at least during one year (interferon ?-1a [IM or SC], interferon-?-1b or glatiramer acetate).
- •7.Patients who grant their written consent after they have had the nature and purpose of the research explained clearly to them (informed consent in writing).
- •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 18
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Patients with clinical symptoms of MS different from relapsing-remitting MS.
- •2.Patients with a history of chronic immune system disease other than MS, such as documented acquired immunodeficiency syndrome (AIDS).
- •3.Patients with a history of treated or untreated malignant disease of any organ system (except localised basal cell carcinoma of the skin) in the last 5 years, regardless of whether evidence of local relapse or metastasis exists.
- •4.Patients with uncontrolled diabetes mellitus (HbA1c > 7%).
- •5.Patients diagnosed with macular oedema during the screening visit. (Patients with a history of macular oedema will be allowed to take part in the study provided that they do not present with macular oedema at the screening visit.)
- •6.Patients with active systemic bacterial, viral or fungal infections, with documented diagnosis of AIDS, hepatitis B or hepatitis C or who test positive for IgG antibodies against HIV, for hepatitis surface antigen B or for hepatitis C antibodies.
- •7.Patients who test negative for IgG antibodies against the varicella-zoster virus at the screening visit. Patients may be vaccinated once it is established that they have IgG antibodies and could be included at least 1 month4 after vaccination.
- •8.Patients who received live or live attenuated vaccines (including varicella-zoster virus or measles virus) in the 2 months prior to the baseline visit.4
- •9.Patients who received total lymphoid irradiation or bone marrow transplantation in the 2 months prior to the baseline visit.
- •10.Patients who have received treatment with:
- •a.Fingolimod at any time, e.g. participation in a fingolimod clinical trial.
- •b.Immunosuppressant drugs such as azathioprine or methotrexate at any time.
- •c.Immunoglobulins in the past 6 months.
- •d.Monoclonal antibodies, including natalizumab, at any time.
- •e.Cladribine, cyclophosphamide or mitoxantrone at any time.
- •11.Patients with any unstable medical condition as assessed by the primary treating physician in each centre, e.g. patients with cardiac risk factors (any degree of atrioventricular block, branch block conduction abnormalities or intraventricular conduction block, or patients who have had severe cardiac syncope) or with a slow (bradycardia) or irregular heartbeat.
- •12.Patients who have taken part in a clinical trial in the last three months.
- •13.Women of childbearing potential who are planning to become pregnant, are pregnant and/or breastfeeding, or who do not wish to use effective contraception, e.g. hormonal contraceptives (implantation, patches, oral) and double-barrier methods (any double combination of: IUD, male or female condoms with spermicidal gel, diaphragm, contraceptive sponge, cervical cap).
- •14.Patients with severe hepatic impairment (Child-Pugh class C).
研究者
相似试验
进行中（未招募）
不适用
An open-label, randomized, multi-center, parallel group non-inferiority study of subcutaneous injections of RO0503821 given once monthly vs darbepoetin alfa given according to local label in patients with chronic kidney disease who are not on dialysis - NDChronic renal anemiaMedDRA version: 9.1Level: LLTClassification code 10002073Term: Anaemia of chronic diseaseEUCTR2006-004552-21-ITROCHE264
进行中（未招募）
1 期
An open-label, randomized, multi-center, parallel group non-inferiority study of subcutaneous injections of RO0503821 given once monthly vs. darbepoetin alfa given according to local label in patients with chronic kidney disease who are not on dialysis - SUSTENTOMedDRA version: 8.1Level: LLTClassification code 10058124Term: Nephrogenic anemiaChronic kidney diseaseEUCTR2006-004552-21-GBF. Hoffmann-La Roche Ltd200
进行中（未招募）
不适用
An open-label, randomized, multi-center, parallel group non-inferiority study of subcutaneous injections of RO0503821 given once monthly vs. darbepoetin alfa given according to local label in patients with chronic kidney disease who are not on dialysis - SUSTENTOMedDRA version: 8.1Level: LLTClassification code 10058124Term: Nephrogenic anemiaChronic kidney diseaseEUCTR2006-004552-21-CZF. Hoffmann-La Roche Ltd200
进行中（未招募）
1 期
An open-label, randomized, multi-center, parallel group non-inferiority study of subcutaneous injections of RO0503821 given once monthly vs. darbepoetin alfa given according to local label in patients with chronic kidney disease who are not on dialysisMedDRA version: 8.1Level: LLTClassification code 10058124Term: Nephrogenic anemiaChronic kidney diseaseEUCTR2006-004552-21-FRF. Hoffmann-La Roche Ltd264
进行中（未招募）
不适用
An open-label, randomized, multi-center, parallel group non-inferiority study of subcutaneous injections of RO0503821 given once monthly vs. darbepoetin alfa given according to local label in patients with chronic kidney disease who are not on dialysis - SUSTENTOChronic kidney diseaseEUCTR2006-004552-21-DEF. Hoffmann-La Roche Ltd200