Working… Menu
Trial record 1 of 14 for:    COPAXONE | Multiple Sclerosis | Italy
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02499900
Recruitment Status : Completed
First Posted : July 16, 2015
Results First Posted : August 20, 2018
Last Update Posted : October 16, 2018
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Pharmaceutical Industries, Ltd. )

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Copaxone® Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 861 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 10, 2015
Actual Primary Completion Date : January 10, 2017
Actual Study Completion Date : June 2, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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 Name: 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 Name: Glatiramer Acetate

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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

  3. 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

  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.

  5. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02499900

  Hide Study Locations
Layout table for location information
United States, Alabama
Teva Investigational Site 13485
Cullman, Alabama, United States, 35058
United States, California
Teva Investigational Site 13524
Carmichael, California, United States, 95608
United States, Georgia
Teva Investigational Site 13478
Atlanta, Georgia, United States, 30327
United States, Illinois
Teva Investigational Site 13475
Northbrook, Illinois, United States, 60062
United States, Massachusetts
Teva Investigational Site 13472
Foxboro, Massachusetts, United States, 2035
United States, Minnesota
Teva Investigational Site 13479
Golden Valley, Minnesota, United States, 55422
Teva Investigational Site 13483
Golden Valley, Minnesota, United States, 55422
United States, Nevada
Teva Investigational Site 13487
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Teva Investigational Site 13470
Teaneck, New Jersey, United States, 07666
United States, New York
Teva Investigational Site 13482
New Hyde Park, New York, United States, 11042
United States, North Carolina
Teva Investigational Site 13471
Raleigh, North Carolina, United States, 27607
United States, Ohio
Teva Investigational Site 13473
Columbus, Ohio, United States, 43214
Teva Investigational Site 13477
Uniontown, Ohio, United States, 44685
United States, Texas
Teva Investigational Site 13481
Round Rock, Texas, United States, 78681
United States, Virginia
Teva Investigational Site 13480
Virginia Beach, Virginia, United States, 23456
Teva Investigational Site 20061
Buenos Aires, Argentina, C1061ABD
Teva Investigational Site 20062
Buenos Aires, Argentina, C1280AEB
Teva Investigational Site 20063
Rosario, Argentina, S2002KQJ
Teva Investigational Site 33040
Wien, Austria, 1010
Teva Investigational Site 37066
Bruxelles, Belgium, 1200
Teva Investigational Site 37063
Edegem, Belgium, 2650
Teva Investigational Site 60037
Rijeka, Croatia, 51000
Teva Investigational Site 60039
Slavonski Brod, Croatia, 35000
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
Zagreb, Croatia, 10000
Teva Investigational Site 40014
Tampere, Finland, FI-33100
Teva Investigational Site 40015
Turku, Finland, 20520
Teva Investigational Site 35211
Besancon, France, 25030
Teva Investigational Site 35203
Bordeaux, France, 33076
Teva Investigational Site 35207
Bron Cedex, France, 69677
Teva Investigational Site 35207
Bron, France, 69677
Teva Investigational Site 35210
Clermont-Ferrand, France, 63003
Teva Investigational Site 35208
Lille, France, 59000
Teva Investigational Site 35214
Lomme, France, 59160
Teva Investigational Site 35204
Nancy, France, 54035
Teva Investigational Site 35205
Nice, France, ?06002
Teva Investigational Site 35206
Nimes, France, 30029
Teva Investigational Site 35212
Nimes, France, 30029
Teva Investigational Site 35213
Poissy, France, 78303
Teva Investigational Site 35202
Rennes, France, 35033
Teva Investigational Site 35201
Strasbourg, France, 67091
Teva Investigational Site 35209
Toulouse, France, 31059
Teva Investigational Site 32605
Bayreuth, Germany, 95445
Teva Investigational Site 32603
Dresden, Germany, ?01307
Teva Investigational Site 32602
Hamburg, Germany, 20249
Teva Investigational Site 32606
Rostock, Germany, 18147
Teva Investigational Site 32604
Stuttgart, Germany, 70174
Teva Investigational Site 44029
Dublin, Ireland
Teva Investigational Site 30169
Bari, Italy, 70124
Teva Investigational Site 30163
Genova, Italy, 16132
Teva Investigational Site 30165
Milano, Italy, 20122
Teva Investigational Site 30164
Milano, Italy, 20127
Teva Investigational Site 30161
Montichiari, Italy, 25018
Teva Investigational Site 30167
Naples, Italy, 80138
Teva Investigational Site 30166
Rome, Italy, ?00133
Teva Investigational Site 30162
Rome, Italy, ?00152
Teva Investigational Site 21096
DF, Mexico, 03310
Teva Investigational Site 21097
Mexico City, Mexico, 14050
Teva Investigational Site 21095
Mexico City, Mexico, 14269
Teva Investigational Site 21098
Mexico City, Mexico, 3100
Teva Investigational Site 53352
Bydgoszcz, Poland, 85-795
Teva Investigational Site 53354
Gdansk, Poland, 80-803
Teva Investigational Site 53350
Katowice, Poland, 40-635
Teva Investigational Site 53349
Kielce, Poland, 25-726
Teva Investigational Site 53353
Konskie, Poland, 26-200
Teva Investigational Site 53356
Lodz, Poland, 90-324
Teva Investigational Site 53348
Lodz, Poland, 90-549
Teva Investigational Site 53345
Lublin, Poland, 20-016
Teva Investigational Site 53355
Olsztyn, Poland, 10-560
Teva Investigational Site 53351
Rybnik, Poland, 44-200
Teva Investigational Site 53347
Rzeszow, Poland, 35-055
Teva Investigational Site 53346
Warszawa, Poland, ?00-909
Puerto Rico
Teva Investigational Site 13476
Guaynabo, Puerto Rico, 00969
Russian Federation
Teva Investigational Site 50392
Kaluga, Russian Federation, 248007
Teva Investigational Site 50390
Kazan, Russian Federation, 420021
Teva Investigational Site 50391
Krasnoyarsk, Russian Federation, 660049
Teva Investigational Site 50387
Moscow, Russian Federation, 125367
Teva Investigational Site 50374
Moscow, Russian Federation, 127015
Teva Investigational Site 50373
Moscow, Russian Federation, 603003
Teva Investigational Site 50376
Novosibirsk, Russian Federation, 630007
Teva Investigational Site 50389
Perm, Russian Federation
Teva Investigational Site 50377
St. Petersburg, Russian Federation, 194044
Teva Investigational Site 50375
St. Petersburg, Russian Federation, 197110
Teva Investigational Site 50372
Tyumen, Russian Federation, 625048
Teva Investigational Site 50378
Yaroslavl, Russian Federation, 150030
Teva Investigational Site 31181
Burgos, Spain, 09006
Teva Investigational Site 31179
El Palmar, Spain, 30120
Teva Investigational Site 31180
Madrid, Spain, 28006
Teva Investigational Site 31177
Malaga, Spain, 29010
Teva Investigational Site 31182
Sevilla, Spain, 41009
Teva Investigational Site 31184
Sevilla, Spain, 41010
Teva Investigational Site 31178
Valencia, Spain, 46026
Teva Investigational Site 82052
Ankara, Turkey, ?06100
Teva Investigational Site 82051
Istanbul, Turkey, 34098
Teva Investigational Site 82049
Istanbul, Turkey, 34250
Teva Investigational Site 82050
Kocaeli, Turkey, 41380
Sponsors and Collaborators
Teva Pharmaceutical Industries, Ltd.
Layout table for investigator information
Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Teva Pharmaceutical Industries, Ltd. Identifier: NCT02499900     History of Changes
Other Study ID Numbers: TV44400-CNS-40083
2015-000922-12 ( EudraCT Number )
First Posted: July 16, 2015    Key Record Dates
Results First Posted: August 20, 2018
Last Update Posted: October 16, 2018
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Glatiramer Acetate
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents