EUCTR2009-015318-23-GB进行中（未招募）1 期
A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION) - SELECTED
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Biogen
- 入组人数
- 410
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. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use PHI in accordance with national and local subject privacy regulations.
- •2. Must be a subject from Study 205MS202 who completed at least 52 weeks and must have been compliant with the 205MS202 protocol in the opinion of the Investigator.
- •3. Women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment.
- •Inclusion criteria for the 2013-2014 Influenza Vaccine Substudy:
- •1. Subjects must provide specific informed consent for the 2013-2014 Influenza Vaccine Substudy
- •2. Subjects must have completed at least 3 months of uninterrupted therapy with DAC HYP prior to entering the 2013-2014 Influenza Vaccine Substudy
- •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 450
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects with any significant change in their medical status from the previous study that would preclude administration of DAC HYP, including laboratory tests or a current clinically-significant condition that, in the opinion of the Investigator, would have excluded the subject’s participation in the 205MS201 or 205MS202 studies. The Investigator must re review the subject’s medical fitness for participation and must consider any diseases that would preclude treatment.
- •2. Any subject who has permanently discontinued study treatment in Study 205MS202 due to an AE.
- •3. Current enrollment in any investigational drug study other than 205MS202.
- •4. Ongoing treatment with any approved or experimental disease-modifying treatment for MS.
- •5.For subjects currently taking valproic acid, carbamazepine, lamotrigine, or phenytoin: Subjects treated with any of these agents for fewer than 6 months prior to study entry are excluded from study participation unless they discontinue the agent(s) prior to study entry.*
- •- Subjects treated with 2 or more of these agents for more than 6 months prior to study entry are excluded from study participation unless they reduce to =1 agent prior to study entry.*
- •- Subjects who have had dose escalations of one of these agents within the 6 months prior to study entry are excluded from study participation unless they revert to a previous dose that had been used for at least 6 months prior to study entry or unless they discontinue the agent prior to study entry.*
- •*Subjects may use an alternative medication allowed by the protocol as needed.
- •Note: Subjects who have been taking 1 of these medications at a stable dose for at least 6 consecutive months prior to study entry may continue to receive the medication without alteration and are eligible for study participation.
- •6. Subjects who are currently receiving treatment with isoniazid, propylthiouracil, or nimesulide at the time of study entry and are not able to discontinue the agent or change to an alternative medication allowed by the protocol prior to initiation of study treatment in this study.
- •7. Unwillingness or inability to comply with the requirements of the protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject’s ability to comply with the protocol.
- •Exclusion Criteria for the 2013-2014 Influenza Vaccine Substudy:
- •1. Subject has had a severe allergic reaction (e.g., anaphylaxis) to eggs, egg proteins (a vaccine component), or any other component of the trivalent seasonal influenza vaccine.
- •2. Subject has had a serious reaction to previous influenza vaccination.
- •3. Subject has a known latex allergy.
- •4. Subject was previously vaccinated for the 2013-2014 influenza season strain.
- •5. Subject had a respiratory illness in the 2 weeks preceding the planned vaccination with the 2013-2014 trivalent seasonal influenza vaccine.
- •6. Subject has any ongoing adverse event or laboratory abnormality in SELECTED that has resulted in suspension of DAC HYP treatment at the time of enrollment into the 2013-2014 Influenza Vaccine Substudy.
- •7. Subject has received in the last 3 months: blood products oral or intravenous cortic
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