EUCTR2011-000888-27-RO进行中（未招募）1 期
Multi-centre, randomized, double-blind, placebo-controlled, parallel-group, 9 month, equivalence trial comparing the efficacy and safety and tolerability of GTR (Synthon BV) to Copaxone® (Teva) in subjects with relapsing remitting multiple sclerosis followed by an open-label 15 month GTR treatment part evaluating the long-term GTR treatment effects - GATE
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Synthon BV
- 入组人数
- 796
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.Willing and able to sign written Informed Consent;
- •2.Female and male subjects aged 18-55 years inclusive at the time of Informed Consent signing;
- •3.Diagnosis of RRMS according to the revised McDonald criteria (2010 Revisions) [1];
- •4.Screening Expanded Disability Status Scale (EDSS) score of 0.0 up to and including 5.5;
- •5.Neurologically stable with no evidence of relapse within 30 days prior to baseline assessments;
- •6.Experienced at least 1 relapse in the year before first screening assessment;
- •7.At least 1 T1-weighted Gadolinium enhancing (T1-GdE) lesion on routine brain MRI taken within 3 months of starting screening or on screening brain MRI (as confirmed by central imaging laboratory)*;
- •* If an eligible subject has no T1-GdE lesion at the first screening MRI, two repeat MRI scans are allowed which are to be taken at least 30 days after the previous MRI. If there is again no T1-GdE lesion on any of these scans, the subject cannot be randomized.
- •8.Having a routine brain MRI showing maximally 15 T1-GdE lesions if scan is taken without subject receiving immuno-modulatory treatment, or a routine brain MRI showing maximally 5 T1-GdE lesions when taken while on immune-modulatory treatment, or a screening MRI showing maximally 15 T1-GdE lesions;
- •9.Must decline initiation or continuation of treatment with other available disease-modifying drugs for MS, for whatever reason, after having been informed about their respective benefits and possible adverse events by the investigator;
- •10.Female subjects of childbearing potential must agree to practice appropriate contraceptive methods as assessed by the investigator.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 750
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Any life-threatening, medically unstable or otherwise clinically significant condition or findings other than MS, in particular neoplastic disease, seizure disorders, or psychiatric disease (in case of doubt, the responsible Medical Officer will be consulted and a joint documented decision will be made between the investigator and the Medical Officer);
- •2.Any clinically significant deviation from reference ranges in laboratory tests (in case of doubt, responsible Medical Officer will be consulted and a joint documented decision will be made between investigator and the Medical Officer);
- •3.Positive laboratory test results for human immunodeficiency virus (HIV), HBsAg or HCV at screening;
- •4.Any significant deviation from reference ranges for hepatic function as defined by either AST (SGOT), ALT (SGPT), GGT, or AP elevated 3-fold or higher beyond the upper limit of the reference range or total bilirubin elevated 2-fold or higher beyond the upper limit of the reference range (in case subjects are diagnosed with Gilbert’s Syndrome, the Medical Officer needs to be contacted and a joint documented decision will be made between the investigator and the Medical Officer);
- •5.Positive urine drug screen or history of substance abuse within the year before screening (any use of illicit or prescription drugs or alcohol constituting an abuse pattern in the opinion of the investigator);
- •6.Having been treated with or having received
- •a.at any time:
- •glatiramer acetate, cladribine, rituximab, cyclophosphamide, alemtuzumab, or other immunosuppressive treatments with effects potentially lasting for more than 6 months;
- •total lymphoid irradiation or bone marrow transplantation;
- •b.within one year before screening:
- •mitoxantrone, but subject cannot be enrolled when mitoxantrone was taken at a cumulative lifetime dosing above 100 mg/m2;
- •c.within 6 months before screening:
- •fingolimod, immunoglobulins and/or monoclonal antibodies (including natalizumab), leflunomide, or putative MS treatments;
- •chronic oral or injected corticosteroids or injected ACTH (more than 30 consecutive days);
- •d.within 3 months before screening:
- •azathioprine, methotrexate;
- •plasma exchange;
- •any other experimental intervention, in particular experimental drugs;
- •e.within 1 month before screening:
- •Interferon-ß 1a or 1b;
- •short-term oral or injectable corticosteroids for treatment of a relapse;
- •short-term ACTH;
- •7.Having, in the opinion of the investigator, consecutively failed on efficacy grounds two full and adequate courses of accepted treatment modalities (normally at least one year of treatment for each);
- •8.Pregnancy or breastfeeding;
- •9.Known hypersensitivity to gadolinium-containing products, glatiramer acetate or mannitol;
- •10.Having an estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73m2;
- •11.Inability to undergo (repeat) MRI investigations as judged by the investigator, e.g., due to claustrophobia, metal implants or fragments, tattoos or permanent make-up;
- •12.Any reason why, in the investigator's opinion, the subject should not participate.
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