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Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis Treated With Copaxone® (CONFIDENCE)

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ClinicalTrials.gov Identifier: NCT02499900
Recruitment Status : Completed
First Posted : July 16, 2015
Results First Posted : August 20, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )

Tracking Information
First Submitted Date  ICMJE July 1, 2015
First Posted Date  ICMJE July 16, 2015
Results First Submitted Date  ICMJE July 17, 2018
Results First Posted Date  ICMJE August 20, 2018
Last Update Posted Date October 16, 2018
Actual Study Start Date  ICMJE August 10, 2015
Actual Primary Completion Date January 10, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 13, 2015)
Medication Satisfaction Questionnaire (MSQ) [ Time Frame: Months 1, 3, 6, 9, 12 ]
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 times a week (TIW) group and the Copaxone 20 mg/mL once daily (QD) group over 6 months of treatment.
Change History Complete list of historical versions of study NCT02499900 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2018)
  • 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 [ Time Frame: Baseline (Month 0), Months 1, 3 and 6 ]
    Convenience perception was measured by the 3 convenience items (items 4 to 6) within the validated TSQM-9. The responses to each of the 3 convenience items are reported on a 1-to-7 scale. The TSQM-9 convenience scale is computed, for each subject, by adding the 3 items loading on each response with the lowest possible total score (1*3 on the 3 items) subtracted from this composite score, and divided by the greatest possible score (3*7) minus the lowest possible score (3), i.e., 21-3=18. This provides a transformed score between 0 and 1 that was multiplied by 100. The final scale is 0 (Extremely Difficult/Inconvenient) to 100 (Extremely Easy/Convenient). If more than one item is missing, then the convenience scale was considered invalid for that patient. Estimates and p-value are obtained from baseline-adjusted repeated measures ANCOVA with treatment, visit, and Country/Geographical Region as main factors, visit by treatment as the interaction term, and baseline score as the covariate.
  • Change From Baseline in the Modified Fatigue Impact Scale (MFIS) Total Score and Subscales to Month 6 Using a Repeated Measures ANCOVA [ Time Frame: Baseline (Month 0), Months 1, 3 and 6 ]
    MFIS is a modified form of the Fatigue Impact Scale based on items derived from interviews with MS patients concerning how fatigue impacts their lives. It is a structured, self-report questionnaire consisting of 21 items assessing the effects of fatigue. All 21 items are scaled 0 to 4, with higher scores indicating a greater impact of fatigue on patient's activities. The Total MFIS score ranges from 0 to 84, the Physical Subscale from 0 to 36, the Cognitive Subscale from 0 to 40, and the Psychosocial Subscale from 0 to 8. A score of 0 indicates fatigue has no impact on activities and the high-end score indicates fatigue has extreme impact on activities. Negative change from baseline values indicate improvement in the effects of fatigue. Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from
  • Change From Baseline in the Mental Health Index (MHI) Total Score and Subscales to Month 6 Using a Repeated Measures ANCOVA [ Time Frame: Baseline (Month 0), Months 1, 3 and 6 ]
    The MHI consists of 18 items and provides an assessment of 4 subscales of mental health, including Anxiety (5 items), Depression (4 items), Behavioral control (4 items), and Positive Affect (4 items), and 1 Total Score. The subscales and Total Score for analyses range from 0 to 100, with 0 indicating not mentally healthy and 100 indicating superior mental health. Positive change from baseline scores indicate improved mental health. Estimates and p-values are obtained from baseline-adjusted repeated measures ANCOVA model with visit as a repeated effect: change from baseline MHI score=baseline MHI Total Score +treatment +visit +country/geographic region +treatment by visit interaction. If a participant skipped x items of y items, the scale was not computed: - MHI Total Score - 9 of 19 - Anxiety subscale - 2 of 5 - Depression subscale - 2 of 4 - Behavioral Control subscale - 2 of 4 - MHI Positive Affect subscale - 2 of 4
  • Change From Baseline in the Beck Depression Inventory II (BDI-II) Total Score to Month 6 Using a Repeated Measures ANCOVA [ Time Frame: Baseline (Month 0), Months 1, 3 and 6 ]
    Depressive symptoms were measured by the BDI-II, a 21-item, self-reported rating inventory that measures characteristic attitudes and symptoms of depression. The BDI-II assesses mood, pessimism, sense of failure, self-dissatisfaction, guilt, punishment, self-dislike, self-accusation, suicidal ideas, sadness, crying, irritability, social withdrawal, body image, work difficulties, insomnia, fatigue, appetite, weight loss, bodily preoccupation, and loss of libido. Each of the 21 items is rated on a 4-point scale ranging from 0 to 3. BDI-II Total Score indicates the severity of depression and has a total range of 0 to 63. For those clinically diagnosed, scores from 0-13 represent minimal depressive symptoms, scores of 14-19 indicate mild depression, scores of 20-28 indicate moderate depression, and scores of 30-63 indicate severe depression. Negative change from baseline scores indicate improvement.
  • Participants With Treatment-Emergent Adverse Events (TEAEs) During Both the Core Period and Extension Periods [ Time Frame: Core: Day 1 to Month 6 Extension: Month 7 to Month 12 ]
    An adverse event (AE) is defined as any study-related event that represents a change (positive or negative) in frequency or severity from a baseline (prestudy) event (if any), regardless of the presence of causal relationship or medical significance. Treatment-emergent adverse events are defined as any adverse event with a start date on or after the first study dose date. The investigator determined relation to study drug. A severe AE is defined as an inability to carry out usual activities. A serious AE (SAE) is defined by federal regulation as any AE occurring at any dose that results in any of the following outcomes: death, life-threatening AE, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Although a subject may have had 2 or more adverse experiences the subject is counted only once in a category. The same subject may appear in different categories.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2015)
  • Treatment Satisfaction Questionnaire for Medication Convenience (TSQM-9) [ Time Frame: Months 1, 3, 6, 9, 12 ]
  • Symptomatic changes as determined by the Modified Fatigue Impact Scale (MFIS) and Mental Health Inventory (MHI) [ Time Frame: Months 1, 3, 6, 9, 12 ]
  • Modified Fatigue Impact Scale (MFIS) [ Time Frame: Months 1, 3, 6, 9, 12 ]
    Responses are derived from interviews with patients concerning how fatigue impacts their lives. It is a structured, self-report questionnaire that provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning.
  • Mental Health Inventory (MHI) [ Time Frame: Months 1, 3, 6, 9, 12 ]
    Provides an assessment of several domains of mental health including anxiety, depression, behavioral control, positive affect, and general distress.
  • Beck Depression Inventory (BDI-II) [ Time Frame: Months 1, 3, 6, 9, 12 ]
    A self-report rating inventory that measures characteristic attitudes and symptoms of depression
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis Treated With Copaxone®
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Drug: Copaxone®
Subcutaneous Injections
Other Name: Glatiramer Acetate
Study Arms  ICMJE
  • Experimental: 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: Drug: Copaxone®
  • Active Comparator: 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: Drug: Copaxone®
Publications * Cutter G, Veneziano A, Grinspan A, Al-Banna M, Boyko A, Zakharova M, Maida E, Pasic MB, Gandhi SK, Everts R, Cordioli C, Rossi S. Higher satisfaction and adherence with glatiramer acetate 40 mg/mL TIW vs 20 mg/mL QD in RRMS. Mult Scler Relat Disord. 2019 Aug;33:13-21. doi: 10.1016/j.msard.2019.04.036. Epub 2019 May 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 12, 2016)
861
Original Estimated Enrollment  ICMJE
 (submitted: July 13, 2015)
840
Actual Study Completion Date  ICMJE June 2, 2017
Actual Primary Completion Date January 10, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Austria,   Belgium,   Croatia,   Finland,   France,   Germany,   Ireland,   Italy,   Mexico,   Poland,   Puerto Rico,   Russian Federation,   Spain,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02499900
Other Study ID Numbers  ICMJE TV44400-CNS-40083
2015-000922-12 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )
Study Sponsor  ICMJE Teva Pharmaceutical Industries, Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA
PRS Account Teva Pharmaceutical Industries
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP