EUCTR2012-004040-30-AT进行中（未招募）不适用
atalizumab de-escalation to interferon-beta-1b in patients withrelapsing-remitting multiple sclerosis: A multicenter study
Ospedale Regionale di Lugano0 个研究点目标入组 72 人开始时间: 2013年3月12日最近更新:
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
- 72
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
- •· Female or male patients with relapsing-remitting forms of multiple
- •sclerosis (according to McDonald's criteria);
- •· Age between 18 and 70 years;
- •· Natalizumab-treatment for at least 12 months following the current Swiss guidelines for treatment initiation;
- •· Treated with a disease-modifying therapy other than interferon beta-1b for at least 12 months before natalizumab was initiated;
- •· Never treated with interferon beta-1b;
- •· Eligible patients are clinically stable (free from relapses and 6-month confirmed disability progression for at least 6 months) while on natalizumab-treatment and do not show any Gd-enhancement on their last MRI performed while on Tysabri;
- •· In eligible patients MRI were performed in the past as following
- •a) 6-18 months prior to natalizumab-treatment
- •b) at natalizumab start
- •c) 12 months after natalizumab initiation;
- •· Good records with regard to clinical disease activity (relapse rate,
- •EDSS progression) in the year prior to natalizumab and during
- •natalizumab;
- •· Patients who decide to stop natalizumab treatment after a careful
- •benefit/risk assessment. Risk for PML increases with duration of
- •natalizumab exposure, pretreatment with an immunosuppressant
- •agent or serological status of anti-JC-virus positivity;
- •· Patients, who in context with cessation of natalizumab have decided, after a careful benefit/risk assessment, to continue treatment of their MS with Interferon beta-1b;
- •· Women of potential childbearing with active contraceptive methods;
- •· Patients who are willing to undergo study procedures;
- •· Patients who are willing to undergo MRI;
- •· Patients who are willing and able to sign informed consent.
- •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 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •· Patients who have previously entered this study;
- •· Natalizumab-treatment for less than 12 months following the current Swiss guidelines for treatment initiation;
- •· Prior treatment with interferon beta-1b (ever interferon beta-1b);
- •· Sign of clinical disease activity within the 6 months;
- •· One or more relapses and/or 6-month confirmed disability
- •progression during the 6 months prior to the study;
- •· Secondary progressive MS;
- •· Primary progressive MS;
- •· Pregnancy - Serum pregnancy test at screening visit positive- or
- •breast feeding;
- •· Uncontrolled, clinically significant heart diseases, such as
- •arrhythmias, angina, or uncompensated congestive heart failure;
- •· History of severe depression or attempted suicide or current suicidal
- •· Medical or psychiatric conditions that compromise the ability to give informed consent, to comply with the protocol, or to complete the study;
- •· Uncontrolled seizure disorder;
- •· Myopathy or clinically significant liver disease;
- •· Inability, in the opinion of the principal investigator or staff, to comply with protocol requirements for the duration of the study;
- •· Known hypersensitivity to interferon-beta or other human proteins including albumin;
- •· Any contraindication for MRI or contrast administration;
- •· A history of drug abuse in the 6 months prior to screening;
- •· Treatment with any of the following in the 30 days before day 1:
- •systemic corticosteroids, ACTH, or other investigational drugs;
- •· Participation in any other study involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study;
- •· Current participation on other clinical trials;
- •· Treatment with drugs which might interfere with the evaluation of
- •study drugs during the study protocol such as immunomodulants,
- •immunosuppressives other than interferon beta-1b;
- •· Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol such as immunomodulants, immunosuppressives other than interferon beta-1b.
研究者
相似试验
进行中（未招募）
不适用
eutralizing Antibodies to Interferon beta in patients treated with Rebif New Formulation - NAb development with RNFIFNß-naïve patients fulfilling Poser or McDonald criteria for CDMS or MS and in whom a decision has been made to initiate treatment with RNF (Rebif New Formulation).MedDRA version: 9.1Level: LLTClassification code 10028245Term: Multiple sclerosisEUCTR2008-008554-23-SEThe Multiple Sclerosis Research Group, Department of Clinical Neuroscience100
进行中（未招募）
1 期
Antiviral and Immunomodulatory Interferon-Beta in high-risk COVID-19 patientsSARS-CoV 2 infection characterized by a National Early Warning Score lower or equal to 2 and symptoms present for less than 7 daysMedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862MedDRA version: 20.0Level: PTClassification code 10070255Term: Coronavirus test positiveSystem Organ Class: 10022891 - InvestigationsEUCTR2020-003872-42-ITIstituto di Farmacologia Traslazionale - CNR60
已完成
2 期
Interferon alpha in combination with thalidomide in the treatment of metastatic renal cell carcinoma - a randomised phase II studyMetastatic renal cell carcinomaMalignant neoplasm of kidney, except renal pelvisCancerISRCTN11978947K Co-ordinating Committee for Cancer Research (UKCCCR)
进行中（未招募）
1 期
Bevacizumab, Interleukin-2 and Interferon-alpha in metastathic renal cell carcinoma - mRCCEUCTR2009-012010-52-DKDepartment of Oncology, Aarhus University Hospital118
招募中
不适用
eutralizing antibody of Interferon beta on multiple sclerosis (Multi-center clinical studies)Multiple sclerosisJPRN-UMIN000008186Yokohama City University100