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
Overview
- Phase
- Phase 4
- Intervention
- Copaxone®
- Conditions
- Multiple Sclerosis
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Enrollment
- 861
- Locations
- 97
- Primary Endpoint
- Change From Baseline in the Medication Satisfaction Questionnaire (MSQ) to Month 6 Using a Repeated Measures ANCOVA
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Copaxone®
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.
Intervention: Copaxone®
Outcomes
Primary Outcomes
Change From Baseline in the Medication Satisfaction Questionnaire (MSQ) to Month 6 Using a Repeated Measures ANCOVA
Time Frame: 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.
Secondary Outcomes
- 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)