EUCTR2009-014392-51-PL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 relapsing multiple sclerosis
适应症
试验速览
- 阶段
- 1 期
- 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 core study CBAF312A2201
- •2.Written informed consent provided before any assessment of the extension study
- •3.Female patients at risk of becoming pregnant must have a negative pregnancy test and use simultaneously two forms of effective contraception during dosing and for 30 days after the
- •last dose of BAF312.
- •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 275
- •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 due to occurrence of discontinuation withdrawal criteria or due to non-compliance.
- •2.Newly diagnosed systemic disease other than MS which may require immunosuppressive treatment
- •3.Presence of malignancy (except for successfully-treated basal or squamous cell carcinoma of skin)
- •4.Diagnosis of macular edema. Patients with ME history are allowed to enter into the extension phase if ME did not occur during the core study or at the Screening visit for the extension
- •5.Newly diagnosed diabetes mellitus or a blood glucose obtained suspicious for diabetes
- •6.Active systemic bacterial, viral or fungal infections, or known to have AIDS, defined as a positive HIV antibody test, Hepatitis B, Hepatitis C infection, defined as Hepatitis B surface antigen or Hepatitis antibody tests, respectively, or having a positive referring laboratory test
- •7.Any medically unstable condition, as assessed by the treating physician
- •8.Any of the following CV conditions:
- •history or presence of stable or unstable IHD, MI, myocarditis or cardiomyopathy;
- •cardiac failure (NYHA Class II-IV) or any severe cardiac disease
- •history or presence of symptomatic arrhythmia requiring current treatment or being otherwise of clinical significance
- •history or presence of a clinically relevant impairment of cardiay conduction including sick sinus syndrome, sino-atrial heart block
- •clinically significant AV block, bundle branch block or an increased QTc interval > 440 msec on screening electrocardiogram (ECG) prior to enrollment
- •arterial hypertension, uncontrolled by medication
- •newly diagnosed Raynaud’s syndrome
- •history of symptomatic bradycardia
- •required treatment with medication that impairs cardiac conduction with the exception of beta-blockers (Section 5.5.7) (e.g., beta blockers, verapamil-type and diltiazem-type calcium-channel blockers, or cardiac glycosides)
- •history of syncope of suspected cardiac origin
- •history of catheter ablation
- •9.Any of the following pulmonary conditions:
- •Severe respiratory disease or pulmonary fibrosis diagnosed during the core study
- •TB, except for history of successfully treated TB or history of prophylactic treatment after positive PPD skin reaction
- •Abnormal chest x-ray or HRCT suggestive of active pulmonary disease in the core study or at screening (if appropriate) in the extension
- •Abnormal pulmonary function tests: FEV1 or FVC values lowed than 70% of predicted value
- •chronic (daily) treatment for asthma
- •10.History or presence, i.e any use of illicit or prescription drugs or alcohol constituting an abuse pattern
- •11.Use of other investigational drugs during the study participation
- •12.Patients using (or having used within 4 weeks or 5 half-lives, whichever is greater before initial dosing) concomitant medications that are potent inducers of CYP2C9 (see Appendix 3 )
- •13.Pregnant or nursing (lactating) women
- •14.Have received any vaccination with live or live attenuated vaccines (including for varicella-zoster virus or measles) within 2 months prior to dosing in the extension
- •15.Have received total lymphoid irradiation or bone marry transplantation
- •16.Any of the following abnormal laboratory values at entering the extension assessment:
- •Total bilirubin greater than the ULN unless in context of Gilbert’s syndrome
- •Conjugated bilirubin greater than the ULN
- •AP greater than 1.5 x ULN
- •AST or SGOT, ALT or SGPT greater than 2 x ULN
研究者
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