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Multiple SclerosisPhase 4CONFIDENCENCT02499900

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

A Phase 4 study testing Copaxone® in people with Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 97 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
Copaxone®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
861 participants
Where
97 sitesin 16 countries
Study dates
10 Aug 2015to 2 Jun 2017
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

97 sites in 16 countries.

97 sites in 16 countries

United States15 sites

  • Teva Investigational Site 13478

    Atlanta, Georgia, 30327

  • Teva Investigational Site 13524

    Carmichael, California, 95608

  • Teva Investigational Site 13473

    Columbus, Ohio, 43214

  • Teva Investigational Site 13485

    Cullman, Alabama, 35058-1565

  • Teva Investigational Site 13472

    Foxborough, Massachusetts, 02035

  • Teva Investigational Site 13479

    Golden Valley, Minnesota, 55422

  • Teva Investigational Site 13483

    Golden Valley, Minnesota, 55422

  • Teva Investigational Site 13487

    Las Vegas, Nevada, 89106

  • Teva Investigational Site 13482

    New Hyde Park, New York, 11042

  • Teva Investigational Site 13475

    Northbrook, Illinois, 60062

  • Teva Investigational Site 13471

    Raleigh, North Carolina, 27607

  • Teva Investigational Site 13481

    Round Rock, Texas, 78681

  • Teva Investigational Site 13470

    Teaneck, New Jersey, 07666

  • Teva Investigational Site 13477

    Uniontown, Ohio, 44685

  • Teva Investigational Site 13480

    Virginia Beach, Virginia, 23456

Other trials in United States

France14 sites

  • Teva Investigational Site 35211

    Besançon, 25030

  • Teva Investigational Site 35203

    Bordeaux, 33076

  • Teva Investigational Site 35207

    Bron, 69677

  • Teva Investigational Site 35210

    Clermont-Ferrand, 63003

  • Teva Investigational Site 35208

    Lille, 59000

  • Teva Investigational Site 35214

    Lomme, 59160

  • Teva Investigational Site 35204

    Nancy, 54035

  • Teva Investigational Site 35205

    Nice, 6002

  • Teva Investigational Site 35206

    Nîmes, 30029

  • Teva Investigational Site 35212

    Nîmes, 30029

  • Teva Investigational Site 35213

    Poissy, 78303

  • Teva Investigational Site 35202

    Rennes, 35033

  • Teva Investigational Site 35201

    Strasbourg, 67091

  • Teva Investigational Site 35209

    Toulouse, 31059

Other trials in France

Poland12 sites

  • Teva Investigational Site 53352

    Bydgoszcz, 85-795

  • Teva Investigational Site 53354

    Gdansk, 80-803

  • Teva Investigational Site 53353

    Gmina Końskie, 26-200

  • Teva Investigational Site 53350

    Katowice, 40-635

  • Teva Investigational Site 53349

    Kielce, 25-726

  • Teva Investigational Site 53356

    Lodz, 90-324

  • Teva Investigational Site 53348

    Lodz, 90-549

  • Teva Investigational Site 53345

    Lublin, 20-016

  • Teva Investigational Site 53355

    Olsztyn, 10-560

  • Teva Investigational Site 53351

    Rybnik, 44-200

  • Teva Investigational Site 53347

    Rzeszów, 35-055

  • Teva Investigational Site 53346

    Warsaw, ?00-909

Other trials in Poland

Russia12 sites

  • Teva Investigational Site 50392

    Kaluga, 248007

  • Teva Investigational Site 50390

    Kazan', 420021

  • Teva Investigational Site 50391

    Krasnoyarsk, 660049

  • Teva Investigational Site 50387

    Moscow, 125367

  • Teva Investigational Site 50374

    Moscow, 127015

  • Teva Investigational Site 50373

    Moscow, 603003

  • Teva Investigational Site 50376

    Novosibirsk, 630007

  • Teva Investigational Site 50389

    Perm

  • Teva Investigational Site 50377

    Saint Petersburg, 194044

  • Teva Investigational Site 50375

    Saint Petersburg, 197110

  • Teva Investigational Site 50372

    Tyumen, 625048

  • Teva Investigational Site 50378

    Yaroslavl, 150030

Other trials in Russia

Italy8 sites

  • Teva Investigational Site 30169

    Bari, 70124

  • Teva Investigational Site 30163

    Genova, 16132

  • Teva Investigational Site 30165

    Milan, 20122

  • Teva Investigational Site 30164

    Milan, 20127

  • Teva Investigational Site 30161

    Montichiari, 25018

  • Teva Investigational Site 30167

    Naples, 80131

  • Teva Investigational Site 30166

    Rome, ?00133

  • Teva Investigational Site 30162

    Rome, ?00152

Other trials in Italy

Spain7 sites

  • Teva Investigational Site 31181

    Burgos, 09006

  • Teva Investigational Site 31179

    El Palmar, 30120

  • Teva Investigational Site 31180

    Madrid, 28006

  • Teva Investigational Site 31177

    Málaga, 29010

  • Teva Investigational Site 31182

    Seville, 41009

  • Teva Investigational Site 31184

    Seville, 41010

  • Teva Investigational Site 31178

    Valencia, 46026

Other trials in Spain

Croatia6 sites

  • Teva Investigational Site 60037

    Rijeka, 51000

  • Teva Investigational Site 60039

    Slavonski Brod, 35000

  • Teva Investigational Site 60034

    Zagreb, 10000

  • Teva Investigational Site 60035

    Zagreb, 10000

  • Teva Investigational Site 60036

    Zagreb, 10000

  • Teva Investigational Site 60040

    Zagreb, 10000

Other trials in Croatia

Germany5 sites

  • Teva Investigational Site 32605

    Bayreuth, 95445

  • Teva Investigational Site 32603

    Dresden, ?01307

  • Teva Investigational Site 32602

    Hamburg, 20249

  • Teva Investigational Site 32606

    Rostock, 18147

  • Teva Investigational Site 32604

    Stuttgart, 70174

Other trials in Germany

Mexico4 sites

  • Teva Investigational Site 21096

    DF, 03310

  • Teva Investigational Site 21097

    Mexico City, 14050

  • Teva Investigational Site 21095

    Mexico City, 14269

  • Teva Investigational Site 21098

    Mexico City, 3100

Other trials in Mexico

Turkey (Türkiye)4 sites

  • Teva Investigational Site 82052

    Ankara, ?06100

  • Teva Investigational Site 82051

    Istanbul, 34098

  • Teva Investigational Site 82049

    Istanbul, 34250

  • Teva Investigational Site 82050

    Kocaeli, 41380

Other trials in Turkey (Türkiye)

Argentina3 sites

  • Teva Investigational Site 20061

    Buenos Aires, C1061ABD

  • Teva Investigational Site 20062

    Buenos Aires, C1280AEB

  • Teva Investigational Site 20063

    Rosario, S2002KQJ

Other trials in Argentina

Belgium2 sites

  • Teva Investigational Site 37066

    Brussels, 1200

  • Teva Investigational Site 37063

    Edegem, 2650

Other trials in Belgium

Finland2 sites

  • Teva Investigational Site 40014

    Tampere, 33100

  • Teva Investigational Site 40015

    Turku, 20520

Other trials in Finland

Austria1 site

  • Teva Investigational Site 33040

    Vienna, 1010

Other trials in Austria

Ireland1 site

  • Teva Investigational Site 44029

    Dublin

Other trials in Ireland

Puerto Rico1 site

  • Teva Investigational Site 13476

    Guaynabo, 00969

Other trials in Puerto Rico

About this study

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

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.

Being tested
Copaxone®
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Copaxone®Drug

    Also called Glatiramer Acetate

    Subcutaneous Injections

Study groups in NCT02499900
Study groupRoleWhat they receive
Copaxone® 40 mg/mLExperimentalSubcutaneous 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.
Receives: Drug: Copaxone®
Copaxone® 20 mg/mLActive comparatorSubcutaneous 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.
Receives: Drug: Copaxone®

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

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

Secondary outcomes (5)

  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

    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.

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

  2. Change From Baseline in the Modified Fatigue Impact Scale (MFIS) Total Score and Subscales to Month 6 Using a Repeated Measures ANCOVA

    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

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

  3. Change From Baseline in the Mental Health Index (MHI) Total Score and Subscales to Month 6 Using a Repeated Measures ANCOVA

    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

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

  4. Change From Baseline in the Beck Depression Inventory II (BDI-II) Total Score to Month 6 Using a Repeated Measures ANCOVA

    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.

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

  5. Participants With Treatment-Emergent Adverse Events (TEAEs) During Both the Core Period and Extension Periods

    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.

    Measured: Core: Day 1 to Month 6 Extension: Month 7 to Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2015 (estimated)
  2. Study start10 Aug 2015
  3. Primary completion10 Jan 2017
  4. Study completion2 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
861 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02499900
Sponsor's protocol ID
TV44400-CNS-40083
Other IDs
2015-000922-12, 2015
Acronym
CONFIDENCE
Status last verified
Dec 2021
First submitted
1 Jul 2015
Last updated
9 Dec 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

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.

    PubMed 31132664

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Copaxone® in people with Multiple Sclerosis, run by Teva Branded Pharmaceutical Products R&D, Inc. at 97 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 97 sites in United States, France, Poland, Russia, Italy and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02499900, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.

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