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

December 7, 2021 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
861

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1061ABD
        • Teva Investigational Site 20061
      • Buenos Aires, Argentina, C1280AEB
        • Teva Investigational Site 20062
      • Rosario, Argentina, S2002KQJ
        • Teva Investigational Site 20063
  • Austria
      • Wien, Austria, 1010
        • Teva Investigational Site 33040
  • Belgium
      • Bruxelles, Belgium, 1200
        • Teva Investigational Site 37066
      • Edegem, Belgium, 2650
        • Teva Investigational Site 37063
  • Croatia
      • Rijeka, Croatia, 51000
        • Teva Investigational Site 60037
      • Slavonski Brod, Croatia, 35000
        • Teva Investigational Site 60039
      • Zagreb, Croatia, 10000
        • Teva Investigational Site 60034
      • Zagreb, Croatia, 10000
        • Teva Investigational Site 60035
      • Zagreb, Croatia, 10000
        • Teva Investigational Site 60036
      • Zagreb, Croatia, 10000
        • Teva Investigational Site 60040
  • Finland
      • Tampere, Finland, 33100
        • Teva Investigational Site 40014
      • Turku, Finland, 20520
        • Teva Investigational Site 40015
  • France
      • Besancon, France, 25030
        • Teva Investigational Site 35211
      • Bordeaux, France, 33076
        • Teva Investigational Site 35203
      • Bron Cedex, France, 69677
        • Teva Investigational Site 35207
      • Clermont-Ferrand, France, 63003
        • Teva Investigational Site 35210
      • Lille, France, 59000
        • Teva Investigational Site 35208
      • Lomme, France, 59160
        • Teva Investigational Site 35214
      • Nancy, France, 54035
        • Teva Investigational Site 35204
      • Nice, France, 6002
        • Teva Investigational Site 35205
      • Nimes, France, 30029
        • Teva Investigational Site 35206
      • Nimes, France, 30029
        • Teva Investigational Site 35212
      • Poissy, France, 78303
        • Teva Investigational Site 35213
      • Rennes, France, 35033
        • Teva Investigational Site 35202
      • Strasbourg, France, 67091
        • Teva Investigational Site 35201
      • Toulouse, France, 31059
        • Teva Investigational Site 35209
  • Germany
      • Bayreuth, Germany, 95445
        • Teva Investigational Site 32605
      • Dresden, Germany, ?01307
        • Teva Investigational Site 32603
      • Hamburg, Germany, 20249
        • Teva Investigational Site 32602
      • Rostock, Germany, 18147
        • Teva Investigational Site 32606
      • Stuttgart, Germany, 70174
        • Teva Investigational Site 32604
  • Ireland
      • Dublin, Ireland
        • Teva Investigational Site 44029
  • Italy
      • Bari, Italy, 70124
        • Teva Investigational Site 30169
      • Genova, Italy, 16132
        • Teva Investigational Site 30163
      • Milano, Italy, 20122
        • Teva Investigational Site 30165
      • Milano, Italy, 20127
        • Teva Investigational Site 30164
      • Montichiari, Italy, 25018
        • Teva Investigational Site 30161
      • Naples, Italy, 80131
        • Teva Investigational Site 30167
      • Rome, Italy, ?00133
        • Teva Investigational Site 30166
      • Rome, Italy, ?00152
        • Teva Investigational Site 30162
  • Mexico
      • DF, Mexico, 03310
        • Teva Investigational Site 21096
      • Mexico City, Mexico, 14050
        • Teva Investigational Site 21097
      • Mexico City, Mexico, 14269
        • Teva Investigational Site 21095
      • Mexico City, Mexico, 3100
        • Teva Investigational Site 21098
  • Poland
      • Bydgoszcz, Poland, 85-795
        • Teva Investigational Site 53352
      • Gdansk, Poland, 80-803
        • Teva Investigational Site 53354
      • Katowice, Poland, 40-635
        • Teva Investigational Site 53350
      • Kielce, Poland, 25-726
        • Teva Investigational Site 53349
      • Konskie, Poland, 26-200
        • Teva Investigational Site 53353
      • Lodz, Poland, 90-324
        • Teva Investigational Site 53356
      • Lodz, Poland, 90-549
        • Teva Investigational Site 53348
      • Lublin, Poland, 20-016
        • Teva Investigational Site 53345
      • Olsztyn, Poland, 10-560
        • Teva Investigational Site 53355
      • Rybnik, Poland, 44-200
        • Teva Investigational Site 53351
      • Rzeszow, Poland, 35-055
        • Teva Investigational Site 53347
      • Warszawa, Poland, ?00-909
        • Teva Investigational Site 53346
  • Puerto Rico
      • Guaynabo, Puerto Rico, 00969
        • Teva Investigational Site 13476
  • Russian Federation
      • Kaluga, Russian Federation, 248007
        • Teva Investigational Site 50392
      • Kazan, Russian Federation, 420021
        • Teva Investigational Site 50390
      • Krasnoyarsk, Russian Federation, 660049
        • Teva Investigational Site 50391
      • Moscow, Russian Federation, 125367
        • Teva Investigational Site 50387
      • Moscow, Russian Federation, 127015
        • Teva Investigational Site 50374
      • Moscow, Russian Federation, 603003
        • Teva Investigational Site 50373
      • Novosibirsk, Russian Federation, 630007
        • Teva Investigational Site 50376
      • Perm, Russian Federation
        • Teva Investigational Site 50389
      • St. Petersburg, Russian Federation, 194044
        • Teva Investigational Site 50377
      • St. Petersburg, Russian Federation, 197110
        • Teva Investigational Site 50375
      • Tyumen, Russian Federation, 625048
        • Teva Investigational Site 50372
      • Yaroslavl, Russian Federation, 150030
        • Teva Investigational Site 50378
  • Spain
      • Burgos, Spain, 09006
        • Teva Investigational Site 31181
      • El Palmar, Spain, 30120
        • Teva Investigational Site 31179
      • Madrid, Spain, 28006
        • Teva Investigational Site 31180
      • Malaga, Spain, 29010
        • Teva Investigational Site 31177
      • Sevilla, Spain, 41009
        • Teva Investigational Site 31182
      • Sevilla, Spain, 41010
        • Teva Investigational Site 31184
      • Valencia, Spain, 46026
        • Teva Investigational Site 31178
  • Turkey
      • Ankara, Turkey, ?06100
        • Teva Investigational Site 82052
      • Istanbul, Turkey, 34098
        • Teva Investigational Site 82051
      • Istanbul, Turkey, 34250
        • Teva Investigational Site 82049
      • Kocaeli, Turkey, 41380
        • Teva Investigational Site 82050
  • United States
    • Alabama
      • Cullman, Alabama, United States, 35058-1565
        • Teva Investigational Site 13485
    • California
      • Carmichael, California, United States, 95608
        • Teva Investigational Site 13524
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Teva Investigational Site 13478
    • Illinois
      • Northbrook, Illinois, United States, 60062
        • Teva Investigational Site 13475
    • Massachusetts
      • Foxboro, Massachusetts, United States, 02035
        • Teva Investigational Site 13472
    • Minnesota
      • Golden Valley, Minnesota, United States, 55422
        • Teva Investigational Site 13479
      • Golden Valley, Minnesota, United States, 55422
        • Teva Investigational Site 13483
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Teva Investigational Site 13487
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Teva Investigational Site 13470
    • New York
      • New Hyde Park, New York, United States, 11042
        • Teva Investigational Site 13482
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Teva Investigational Site 13471
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Teva Investigational Site 13473
      • Uniontown, Ohio, United States, 44685
        • Teva Investigational Site 13477
    • Texas
      • Round Rock, Texas, United States, 78681
        • Teva Investigational Site 13481
    • Virginia
      • Virginia Beach, Virginia, United States, 23456
        • Teva Investigational Site 13480

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Copaxone®
Subcutaneous Injections
Other Names:
  • Glatiramer Acetate
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.
Drug: Copaxone®
Subcutaneous Injections
Other Names:
  • Glatiramer Acetate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (Month 0), Months 1, 3 and 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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
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
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
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
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.
Baseline (Month 0), Months 1, 3 and 6
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.
Core: Day 1 to Month 6 Extension: Month 7 to Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teva Branded Pharmaceutical Products R&D, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 2, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TV44400-CNS-40083
  • 2015-000922-12 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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