EUCTR2006-002037-20-ES进行中（未招募）1 期
A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) Estudio multinacional, multicéntrico, randomizado, doble ciego, en grupos paralelos, para comparar la eficacia, la tolerabilidad y seguridad del Acetato de Glatiramero inyectable 40 mg/ml frente a Acetato de Glatiramero inyectable 20 mg/ml una vez al día en inyección subcutánea en pacientes con Esclerosis Múltiple Remitente Recurrente (EM-RR) - FORTE
Teva Pharmaceutical Industries, Ltd.0 个研究点目标入组 980 人开始时间: 2006年7月7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
- 980
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
入选标准
- •1. Subjects must have a confirmed and documented MS diganosis as defined by the Revised McDonald criteria [Ann Neurol 2005: 58:840-846].
- •2. Subjects must be of RR MS type [Neurol 1996;46:907-911].
- •3. Subjects must be relapse free and in stable neurological condition at least 30 days prior to screening.
- •4. Subjects must have experienced one of the following:
- •+ At least one documented relapse in the 12 months prior to screening.
- •+ At least two documented relapses in the 24 months prior to screening.
- •+ One documented relapse between 12 and 24 months prior to screening with at
- •least one documented T1-Gd enhancing lesion in an MRI performed within 12
- •months prior to screening.
- •5. Subjects must have a disease duration of at least 6 months prior to screening.
- •6. Subjects must be between 18 and 55 years of age (inclusive).
- •7. Subjects must be ambulatory with converted Kurtzke EDSS score of 0-5.
- •8. Women of child-bearing potential must practice an acceptable method of birth control.
- •9. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
- •10. Subjects must be able to sign and date a written informed consent prior to entering 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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Any treatment with corticosteroids (IV, IM and/or PO) within 30 days prior to screening.
- •2. An onset of relapse or any treatment with corticosteroids (IV, IM and/or PO) between Month -1 (screening) and Month 0 (baseline).
- •3. Chronic (more than 30 consecutive days) corticosteroid treatment (IV, IM; and/or PO) within 6 months prior to screening visit.
- •4. Use of cladribine within 2 years prior to screening.
- •5. Previous total body or lymphoid irradiation.
- •6. Use of immunosuppressive agents (including mitoxantrone) within 6 months prior to screening visit.
- •7. Previous treatment with immunomodulators (including IFN beta 1a and 1b, and IV immunoglobulin) within 2 months prior to screening.
- •8. Previous use of GA.
- •9. Previous use of natalizumab.
- •10. Previous stem cell treatment.
- •10. Use of experimental drugs (including TV-5010, laquinimod and oral GA) within 6 months prior to screening.
- •11. Pregnancy or breastfeeding.
- •12. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical exams, ECG, abnormal laboratory tests and chest X-ray. Such conditions may include hepatic, renal or metabolic diseases, systemic disease, acute infection, current malignancy or recent history (5 years) of malignancy, major psychiatric disorder, history of drug and/or alcohol abuse and allergies that could be detrimental according to the investigator's judgement.
- •13. Subject's inability to complete the study or if the subject is considered by the investigator for any reason to be an unsuitable canditate for this study.
- •14. A known hypersensitivity to mannitol.
- •15. A known hypersensitivity to gadolinium (Gd).
- •16. Inability to successfully undergo MRI scanning.
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