EUCTR2009-014392-51-IT进行中（未招募）不适用
A dose blinded extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with relapsing multiple sclerosis. - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 275
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 completed the treatment in the core study CBAF312A2201; 2. Written informed consent provided at least on day 1 of this extension study; 3. Female patients at risk of becoming pregnant must have a negative pregnancy test and use simultaneously two forms of effective contraception
- •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. Premature discontinuation of the study drug during the core study (CBAF312A2201); 2. Chronic disease of the immune system other than MS which may require immunosuppressive treatment; 3. Presence of malignancy; 4. Newly diagnosed diabetes mellitus or a blood glucose obtained suspicious for diabetes (≥ 126 mg/dl or ≥ 7 mmol/L if fasting; ≥ 200 mg/dl or ≥ 11.1 mmol/L if random); 5. Active systemic bacterial, viral or fungal infections, or known to have AIDS, or having a positive HIV antibody test; 6. Any medically unstable condition, that may interfere with the patient s ability to cooperate and comply with the study procedures, as assessed by the treating physician 7. Any of the following cardiovascular conditions: a. myocardial infarction within the past 6 months prior to entry in the extension or with current unstable ischemic heart disease; b. cardiac failure (Class III, according to New York Heart Association Classification) or any severe cardiac disease as determined by the investigator; c. arrhythmia requiring treatment with Class III antiarrhythmic drugs (e.g., amiodarone, bretylium, sotalol, ibulitide, azimilide, dofelitide); 8. Any of the following pulmonary conditions: a. Severe respiratory disease or pulmonary fibrosis diagnosed during the core study; b. Tuberculosis suspected during core study; c. Abnormal chest x-ray or high resolution computer tomography (HRCT) suggestive of active pulmonary disease in the core study; 9. History of alcohol abuse during the core study; 10. Chronic liver disease such as Hepatitis B, Hepatitis C infection, or having positive referring laboratory tests acquired during the core study; 11. Use of other investigational drugs during the study.
研究者
相似试验
已完成
2 期
Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally in Patients With Relapsing-remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisNCT01185821Novartis Pharmaceuticals185
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An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with multiple sclerosis with relapsesRelapsing multiple sclerosisMedDRA version: 17.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2009-014392-51-FIovartis Pharma Services AG275
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不适用
An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with multiple sclerosis with relapsesRelapsing multiple sclerosisMedDRA version: 18.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2009-014392-51-DEovartis Pharma Services AG275
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An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with multiple sclerosis with relapsesRelapsing multiple sclerosisMedDRA version: 17.0Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2009-014392-51-HUovartis Pharma Services AG275
进行中（未招募）
1 期
An extension study to the CBAF312A2201 study to evaluate long-term safety, tolerability and efficacy of BAF312 given orally once daily in patients with multiple sclerosis with relapsesRelapsing multiple sclerosisMedDRA version: 18.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2009-014392-51-PLovartis Pharma Services AG275