NCT01128075已完成不适用
Multi-center, Two-arm Non-comparative, Observational, 96-week Phase IV Study to Evaluate Treatment Adherence When Using RebiSmart™ for Self-injection of Rebif® in Multi-dose Cartridges in Subjects With Relapsing Multiple Sclerosis (RMS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Treatment adherence for RMS subjects over 24 weeks of treatment when using RebiSmart™ for self-injection of Rebif® in a multi-dose cartridge.
研究概览
简要总结
This is a multi-center, two-arm non-comparative, observational, 96 week Phase IV study to evaluate treatment adherence when using RebiSmart™ for self-injection of Rebif® in subjects with relapsing multiple sclerosis (RMS).
Subjects who have a confirmed diagnosis of RMS using McDonald Criteria and meet the eligibility criteria during a screening period of up to 28 days will be provided with an electronic self-injection device (RebiSmart™) to inject Rebif® for 96 weeks.
The main purpose of this study is to evaluate treatment adherence for subjects with RMS over 24 weeks of treatment when using RebiSmart™ for self-injection of Rebif® in a multi-dose cartridge.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females between 18 and 65 years of age.
- •Have RMS according to the revised McDonald Criteria.
- •Subject is eligible for Rebif® therapy according to indications and clinical use in the Rebif® Product Monograph.
- •Be willing and able to comply with the protocol requirements for the duration of the study.
- •Have given written informed consent prior to entering the screening period.
- •Must register with the Rebif® Multiple Support Program.
- •Subjects previously on disease modifying drugs (DMDs) must be stable and not be experiencing any side effects related to the previous DMDs at the time of enrollment into the study, in the opinion of the investigator. Rebif® will be prescribed as per Product Monograph and a washout period will be left at the discretion of the investigator.
排除标准
- •Have any disease other than MS that could better explain his/her signs and symptoms.
- •Receive any other injectable medications on a regular basis during the week prior to the screening period or throughout the duration of the study. The administration of a single injection for treatment or prophylaxis of a condition unrelated to the subject's MS (e.g.,influenza or pneumococcus vaccination) will be acceptable.
- •Are contraindicated for the use of Rebif® according to the Rebif® Product Monograph.
- •Have a diagnosis of clinically isolated syndrome (CIS).
- •Participation in any other investigational trial prior to 30 days of Study Day
- •Any visual or physical impairment that precludes the subject from self-injecting the treatment using RebiSmart™
- •Have received previous treatment with Rebif within 5 years prior to screening.
- •Subjects have any medical, psychiatric or other conditions that compromise his/her ability to understand the subject information, to give informed consent, to comply with the study protocol or to complete the study questionnaires.
结局指标
主要结局
Treatment adherence for RMS subjects over 24 weeks of treatment when using RebiSmart™ for self-injection of Rebif® in a multi-dose cartridge.
时间窗: 24 weeks
次要结局
- Treatment persistence by measuring treatment discontinuations(96 weeks)
- Long-term adherence in subjects with RMS over 96 weeks of treatment using RebiSmart for self-injection of Rebif® in multi-dose cartridge.(96 weeks)
- Treatment compliance(96 weeks)
- Comparison of subject treatment adherence between categories of cognitive function(96 weeks)
- Longitudinal changes in anxiety symptoms(96 weeks)
- Qualitative assessment of subjects' experience with RebiSmart(96 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
4 期
Study to Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic StrokeAcute Cerebral IschemiaNCT05955326Pharmazz, Inc.160
已完成
4 期
A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory GoutGoutNCT06229145Amgen306
招募中
不适用
Evaluate the SENSE Device's Ability to Monitor and Detect Intracranial HemorrhageIntracranial HemorrhagesTraumatic Brain InjuryNCT04642443Sense Diagnostics, LLC450
Unknown
2 期
A Study of Obinutuzumab (RO5072759) Induction in Patients With Relapsed/ Refractory Waldenström Macroglobulinemia, OBI-1Waldenstrom MacroglobulinemiaNCT03679455Polish Myeloma Consortium30
已完成
3 期
Efficacy and Safety Study of Nicotine Mint Lozenge (2mg and 4mg) in Smoking CessationSmokingNCT00985985GlaxoSmithKline723