CONFIDENCE: A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With Subcutaneous Injections of Copaxone(R) (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 861
- 试验地点
- 97
- 主要终点
- Change From Baseline in the Medication Satisfaction Questionnaire (MSQ) to Month 6 Using a Repeated Measures ANCOVA
研究概览
简要总结
The primary objective of this study is to compare patient medication satisfaction as measured by the Medication Satisfaction Questionnaire (MSQ) scores between the Copaxone 40 mg/mL three time a week (TIW) group and the Copaxone 20 mg/mL once daily (QD) group over 6 months of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women at least 18 years of age or older.
- •Patients must have a confirmed and documented RRMS diagnosis
- •Patients must be ambulatory with a Kurtzke EDSS score of 0 to 5.5 at screening visit.
- •Patients must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment 30 days prior to randomization.
- •Women of child-bearing potential must have a negative urine pregnancy test at screening visit and must practice an acceptable method of birth
- •Patients must be able to sign and date a written informed consent prior to entering the study.
- •Patients must be willing and able to comply with the protocol requirements for the duration of the study.
- •Exclusion Criteria
- •Patient had any contraindication to Copaxone therapy.
- •Previous use of Copaxone 40 mg/mL three times per week.
- •Patients with progressive forms of MS.
- •Patients with neuromyelitis optica.
- •Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
- •Patients who have been treated with; immunosuppressive medications, immunoglobulins and/or monoclonal antibodies, alemtuzumab, cladribine, cyclophosphamide or mitoxantrone at any time
- •Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid treatment within 6 months prior to screening visit.
- •Pregnancy or breastfeeding.
- •Clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation
- •Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
- •other criteria may apply, please contact the investigator for more information
排除标准
- 未提供
研究组 & 干预措施
Copaxone® 40 mg/mL
Subcutaneous Injections 40 mg/mL Three Times a Week for the core period which last 6 months. In the extension period patient are administered Copaxone® 40 mg/mL for months 7 - 12.
干预措施: Copaxone® (Drug)
Copaxone® 20 mg/mL
Subcutaneous Injections 20 mg/mL Daily for the core period which last 6 months. In the extension period patient are administered Copaxone® 40 mg/mL for months 7 - 12.
干预措施: Copaxone® (Drug)
结局指标
主要结局
Change From Baseline in the Medication Satisfaction Questionnaire (MSQ) to Month 6 Using a Repeated Measures ANCOVA
时间窗: Baseline (Month 0), Months 1, 3 and 6
Patient satisfaction with the study medication was assessed using the MSQ a 1-item global patient-rated scale. Patients were asked to respond on a 7-point scale, ranging from extremely dissatisfied (1) to extremely satisfied (7), to the following: "Overall, how satisfied are you with your current medication?". Positive change from baseline score indicates greater satisfaction with the medication. Estimates and p-value are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: MSQ=baseline MSQ score+treatment+visit+treatment by visit interaction.
次要结局
- Change From Baseline in the Treatment Satisfaction Questionnaire for Medication 9-item Version (TSQM-9) Convenience Score to Month 6 Using a Repeated Measures ANCOVA(Baseline (Month 0), Months 1, 3 and 6)
- Change From Baseline in the Modified Fatigue Impact Scale (MFIS) Total Score and Subscales to Month 6 Using a Repeated Measures ANCOVA(Baseline (Month 0), Months 1, 3 and 6)
- Change From Baseline in the Mental Health Index (MHI) Total Score and Subscales to Month 6 Using a Repeated Measures ANCOVA(Baseline (Month 0), Months 1, 3 and 6)
- Change From Baseline in the Beck Depression Inventory II (BDI-II) Total Score to Month 6 Using a Repeated Measures ANCOVA(Baseline (Month 0), Months 1, 3 and 6)
- Participants With Treatment-Emergent Adverse Events (TEAEs) During Both the Core Period and Extension Periods(Core: Day 1 to Month 6 Extension: Month 7 to Month 12)