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CONFIDENCE

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
CompletedPhase 4Relapsing MSNCT024999002015-000922-12

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Change From Baseline in the Medication Satisfaction Questionnaire (MSQ) to Month 6 Using a Repeated Measures ANCOVAMean Difference (Final Values) 0.3210.1615–0.4814<0.001

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

Results by group

Change From Baseline in the Medication Satisfaction Questionnaire (MSQ) to Month 6 Using a Repeated Measures ANCOVA

Baseline (Month 0), Months 1, 3 and 6

GroupValueIntervalNumber analysed
Copaxone® 20 mg/mL QD5.396 units on a scale0.0889 (Standard Error)221
Copaxone® 40 mg/mL TIW5.717 units on a scale0.0879 (Standard Error)235

Copaxone® 20 mg/mL QD

5.396

Copaxone® 40 mg/mL TIW

5.717

p = <0.001; Mean Difference (Final Values) 0.321 (95% CI 0.1615–0.4814)

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Copaxone® 20 mg/mL QD (Core)4278 (1.9%)0
Copaxone® 40 mg/mL TIW (Core)43013 (3.0%)1
Copaxone® 40 mg/mL TIW (Switch-Extension)3923 (0.8%)0
Copaxone® 40 mg/mL TIW (Extension)3962 (0.5%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Change From Baseline in the Medication Satisfaction Questionnaire (MSQ) to Month 6 Using a Repeated Measures ANCOVA

    Baseline (Month 0), Months 1, 3 and 6

    Quality of life (reported by participants)

  • Primary Efficacy Endpoint(s):

Other measures (6)

  • 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

    Quality of life (reported by participants)

  • 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

    Thinking and memoryFatigue

  • 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

    Mood and sleep

  • 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

    FatigueMood and sleepQuality of life (reported by participants)

  • 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

    Safety

  • Secondary Efficacy Endpoints:

Who could take part

Relapsing MS · 18 and over

Inclusion Criteria: 1. Men or women at least 18 years of age or older. 2. Patients must have a confirmed and documented RRMS diagnosis 3. Patients must be ambulatory with a Kurtzke EDSS score of 0 to 5.5 at screening visit. 4. Patients must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment 30 days prior to randomization. 5. Women of child-bearing potential must have a negative urine pregnancy test at screening visit and must practice an acceptable method of birth 6. Patients must be able to sign and date a written informed consent prior to entering the study. 7. Patients must be willing and able to comply with the protocol requirements for the duration of the study. Exclusion Criteria 1. Patient had any contraindication to Copaxone therapy. 2. Previous use of Copaxone 40 mg/mL three times per week. 3. Patients with progressive forms of MS. 4. Patients with neuromyelitis optica. 5. Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening. 6. Patients who have been treated with; immunosuppressive medications, immunoglobulins and/or monoclonal antibodies, alemtuzumab, cladribine, cyclophosphamide or mitoxantrone at any time 7. Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid treatment within 6 months prior to screening visit. 8. Pregnancy or breastfeeding. 9. Clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation 10. 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Aug 2015

    2. Main results due

      Jan 2017

    3. Finished

      Jun 2017

    4. Results posted

      Aug 2018

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