EUCTR2013-002082-19-NL进行中（未招募）不适用
A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate the Efficacy, Safety and Tolerability of 2 Doses of Oral administration of Laquinimod (0.6 mg/day or 1.2 mg/day) compared to Interferon ß-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO
Teva Pharmaceutical Industries, Ltd.0 个研究点目标入组 600 人开始时间: 2013年10月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
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. Subjects must have a confirmed and documented RRMS diagnosis as defined by the Revised McDonald criteria, with relapse onset disease or a relapsing-remitting disease course.
- •2. Subjects must be ambulatory with an Kurtzke EDSS score of 0 5.5 at both at Screening and Baseline (randomization) visits.
- •3. Subjects must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment or adrenocorticotrophic hormone (ACTH), 60 days prior to randomization.
- •4. Subjects must have experienced at least 1 documented relapse in the last year prior to randomization or 2 relapses in the last 3 years prior to randomization.
- •5. Subjects must be between 18 and 55 years of age at screening, inclusive.
- •6. Women of child-bearing potential must practice an acceptable method of birth control until 30 days after the last dose of treatment was administered.
- •7. Subjects must be able to sign and date a written informed consent prior to entering the study.
- •8. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
- •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 600
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1. Subjects with progressive forms of MS.
- •2. Subjects with Neuromyelitis Optica (NMO).
- •3. Use of experimental or investigational drugs and/or participation in drug clinical studies within 6 months prior to Baseline visit (randomization).
- •4. Use of immunosuppressive agents, or cytotoxic agents, including cyclophosphamide and azatioprine within 12 months prior to Baseline.
- •5. Prior use of monoclonal antibodies ever, except for:
- •- Natalizumab (Tysabri®) if given more than 6 months prior to randomization AND the subject is John Cunningham (JC) virus antibody test negative at Screening.
- •- Previous use of Rituximab, ocrelizumab, or ofatumumab is allowed if the B cell count (CD19) is higher than 80 cells /µL.
- •6. Previous treatment with glatiramer acetate (Copaxone® ), fingolimod (Gilenya®), BG-12 (Tecfidera), Teriflunomide (Aubagio®) or intravenous immunoglobulin (IVIG) within 2 months prior to Baseline.
- •7. Use of mitoxantrone (Novantrone) within 5 years prior to Screening. Use of mitoxantrone (Novantrone) >5 years before screening is allowed in subjects with normal ejection fraction and who did not exceed the total lifetime maximal dose.
- •8. Chronic systemic (IV, IM or PO) corticosteroid treatment within 2 months prior to Baseline.
- •9. Previous use of cladribine.
- •10. Previous use of laquinimod or Avonex® IM.
- •11. Treatment with other Interferon-ß (either 1a subcutaneous [SC] or 1b SC) within 60 days before baseline (earlier treatment will be allowed if the reason for discontinuation was not treatment failure or for Interferon-ß related safety reasons. This decision will be taken by the investigator).
- •12. Previous total body irradiation or total lymphoid irradiation.
- •13. Previous stem cell treatment, autologous bone marrow transplantation, or allogenic bone marrow transplantation.
- •14. Acute infection within 2 weeks prior to Baseline visit.
- •15. Major trauma or surgery within 2 weeks prior to Baseline visit.
- •16. Use of moderate/strong inhibitors of CYP3A4 within 2 weeks prior to Baseline.
- •17. Use of inducers of CYP3A4 within 2 weeks prior to Baseline
- •18. Pregnancy or breast feeding.
- •19. Serum levels =3 times (x) upper limit of normal (ULN) of either ALT or AST at Screening.
- •20. Serum direct bilirubin =2xULN at Screening.
- •21. Subjects with a clinically significant or unstable medical or surgical condition or any other condition that cannot be well-controlled by the allowed medications permitted in the study protocol that would preclude safe and complete study participation, as determined by medical history, physical examinations, ECG, laboratory tests MRI or chest X-ray. months prior to randomization.
- •22. Twenty or more gadolinium (Gd)- enhancing (E) lesions on baseline MRI.
- •23. A known history of sensitivity to gadolinium (Gd).
- •24. GFR = 60 mL/min at the screening visit.
- •25. Inability to successfully/safely undergo MRI scanning.
- •26. Subjects who underwent endovascular treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI).
- •27. Known hypersensitivity that would preclude administration of laquinimod capsule, such as hypersensitivity to: mannitol, meglumine, or sodium stearyl fumarate.
- •28. A known history of hypersensitivity to natural or recombinant interferon ß, human albumin, or any other component of the formulation of Avonex®
- •29. Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
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