Phase 4
Completed N=861
Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis Treated With Copaxone®
Source: ClinicalTrials.gov NCT02499900 ↗Enrolled (actual)
861
Serious AEs
1.6%
Results posted
Aug 2018
Primary outcomePrimary: Change From Baseline in the Medication Satisfaction Questionnaire (MSQ) to Month 6 Using a Repeated Measures ANCOVA — 5.396; 5.717 units on a scale — p=<0.001
◆ Published Evidence
Emerging
18citations · ~3 / year
Higher satisfaction and adherence with glatiramer acetate 40 mg/mL TIW vs 20 mg/mL QD in RRMS.
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.
Linked Publications
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Higher satisfaction and adherence with glatiramer acetate 40 mg/mL TIW vs 20 mg/mL QD in RRMS.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Medication Satisfaction Questionnaire (MSQ) to Month 6 Using a Repeated Measures ANCOVA |
5.396; 5.717 | <0.001 sig |
| SECONDARY 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 |
69.740; 79.189 | <0.001 sig |
| SECONDARY Change From Baseline in the Modified Fatigue Impact Scale (MFIS) Total Score and Subscales to Month 6 Using a Repeated Measures ANCOVA |
-2.811; -3.613; -1.483; -1.714; -0.965; -1.604 | 0.208 |
| SECONDARY Change From Baseline in the Mental Health Index (MHI) Total Score and Subscales to Month 6 Using a Repeated Measures ANCOVA |
3.136; 3.842; 5.468; 5.609; 3.773; 4.253 | 0.287 |
| SECONDARY Change From Baseline in the Beck Depression Inventory II (BDI-II) Total Score to Month 6 Using a Repeated Measures ANCOVA |
-1.525; -1.585 | 0.851 |
| SECONDARY Participants With Treatment-Emergent Adverse Events (TEAEs) During Both the Core Period and Extension Periods |
219; 231; 132; 129; 8; 13 | — |
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.
- 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
Data sourced from ClinicalTrials.gov (NCT02499900) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.