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

Multiple Sclerosis Clinical Trial

— CONFIDENCE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02499900
• Other study ID #: TV44400-CNS-40083
• Secondary ID: 2015-000922-12
• Status: Completed
• Phase: Phase 4
• Start date: August 10, 2015
• Est. completion date: June 2, 2017

Study information

• Verified date: December 2021
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 861
• Est. completion date: June 2, 2017
• Est. primary completion date: January 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• Copaxone®
Subcutaneous Injections

Locations

Country	Name	City	State
Argentina	Teva Investigational Site 20061	Buenos Aires
Argentina	Teva Investigational Site 20062	Buenos Aires
Argentina	Teva Investigational Site 20063	Rosario
Austria	Teva Investigational Site 33040	Wien
Belgium	Teva Investigational Site 37066	Bruxelles
Belgium	Teva Investigational Site 37063	Edegem
Croatia	Teva Investigational Site 60037	Rijeka
Croatia	Teva Investigational Site 60039	Slavonski Brod
Croatia	Teva Investigational Site 60034	Zagreb
Croatia	Teva Investigational Site 60035	Zagreb
Croatia	Teva Investigational Site 60036	Zagreb
Croatia	Teva Investigational Site 60040	Zagreb
Finland	Teva Investigational Site 40014	Tampere
Finland	Teva Investigational Site 40015	Turku
France	Teva Investigational Site 35211	Besancon
France	Teva Investigational Site 35203	Bordeaux
France	Teva Investigational Site 35207	Bron Cedex
France	Teva Investigational Site 35210	Clermont-Ferrand
France	Teva Investigational Site 35208	Lille
France	Teva Investigational Site 35214	Lomme
France	Teva Investigational Site 35204	Nancy
France	Teva Investigational Site 35205	Nice
France	Teva Investigational Site 35206	Nimes
France	Teva Investigational Site 35212	Nimes
France	Teva Investigational Site 35213	Poissy
France	Teva Investigational Site 35202	Rennes
France	Teva Investigational Site 35201	Strasbourg
France	Teva Investigational Site 35209	Toulouse
Germany	Teva Investigational Site 32605	Bayreuth
Germany	Teva Investigational Site 32603	Dresden
Germany	Teva Investigational Site 32602	Hamburg
Germany	Teva Investigational Site 32606	Rostock
Germany	Teva Investigational Site 32604	Stuttgart
Ireland	Teva Investigational Site 44029	Dublin
Italy	Teva Investigational Site 30169	Bari
Italy	Teva Investigational Site 30163	Genova
Italy	Teva Investigational Site 30164	Milano
Italy	Teva Investigational Site 30165	Milano
Italy	Teva Investigational Site 30161	Montichiari
Italy	Teva Investigational Site 30167	Naples
Italy	Teva Investigational Site 30162	Rome
Italy	Teva Investigational Site 30166	Rome
Mexico	Teva Investigational Site 21096	DF
Mexico	Teva Investigational Site 21095	Mexico City
Mexico	Teva Investigational Site 21097	Mexico City
Mexico	Teva Investigational Site 21098	Mexico City
Poland	Teva Investigational Site 53352	Bydgoszcz
Poland	Teva Investigational Site 53354	Gdansk
Poland	Teva Investigational Site 53350	Katowice
Poland	Teva Investigational Site 53349	Kielce
Poland	Teva Investigational Site 53353	Konskie
Poland	Teva Investigational Site 53348	Lodz
Poland	Teva Investigational Site 53356	Lodz
Poland	Teva Investigational Site 53345	Lublin
Poland	Teva Investigational Site 53355	Olsztyn
Poland	Teva Investigational Site 53351	Rybnik
Poland	Teva Investigational Site 53347	Rzeszow
Poland	Teva Investigational Site 53346	Warszawa
Puerto Rico	Teva Investigational Site 13476	Guaynabo
Russian Federation	Teva Investigational Site 50392	Kaluga
Russian Federation	Teva Investigational Site 50390	Kazan
Russian Federation	Teva Investigational Site 50391	Krasnoyarsk
Russian Federation	Teva Investigational Site 50373	Moscow
Russian Federation	Teva Investigational Site 50374	Moscow
Russian Federation	Teva Investigational Site 50387	Moscow
Russian Federation	Teva Investigational Site 50376	Novosibirsk
Russian Federation	Teva Investigational Site 50389	Perm
Russian Federation	Teva Investigational Site 50375	St. Petersburg
Russian Federation	Teva Investigational Site 50377	St. Petersburg
Russian Federation	Teva Investigational Site 50372	Tyumen
Russian Federation	Teva Investigational Site 50378	Yaroslavl
Spain	Teva Investigational Site 31181	Burgos
Spain	Teva Investigational Site 31179	El Palmar
Spain	Teva Investigational Site 31180	Madrid
Spain	Teva Investigational Site 31177	Malaga
Spain	Teva Investigational Site 31182	Sevilla
Spain	Teva Investigational Site 31184	Sevilla
Spain	Teva Investigational Site 31178	Valencia
Turkey	Teva Investigational Site 82052	Ankara
Turkey	Teva Investigational Site 82049	Istanbul
Turkey	Teva Investigational Site 82051	Istanbul
Turkey	Teva Investigational Site 82050	Kocaeli
United States	Teva Investigational Site 13478	Atlanta	Georgia
United States	Teva Investigational Site 13524	Carmichael	California
United States	Teva Investigational Site 13473	Columbus	Ohio
United States	Teva Investigational Site 13485	Cullman	Alabama
United States	Teva Investigational Site 13472	Foxboro	Massachusetts
United States	Teva Investigational Site 13479	Golden Valley	Minnesota
United States	Teva Investigational Site 13483	Golden Valley	Minnesota
United States	Teva Investigational Site 13487	Las Vegas	Nevada
United States	Teva Investigational Site 13482	New Hyde Park	New York
United States	Teva Investigational Site 13475	Northbrook	Illinois
United States	Teva Investigational Site 13471	Raleigh	North Carolina
United States	Teva Investigational Site 13481	Round Rock	Texas
United States	Teva Investigational Site 13470	Teaneck	New Jersey
United States	Teva Investigational Site 13477	Uniontown	Ohio
United States	Teva Investigational Site 13480	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Croatia,  Finland,  France,  Germany,  Ireland,  Italy,  Mexico,  Poland,  Puerto Rico,  Russian Federation,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (Month 0), Months 1, 3 and 6
Secondary	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.	Baseline (Month 0), Months 1, 3 and 6
Secondary	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	Baseline (Month 0), Months 1, 3 and 6
Secondary	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	Baseline (Month 0), Months 1, 3 and 6
Secondary	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.	Baseline (Month 0), Months 1, 3 and 6
Secondary	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.	Core: Day 1 to Month 6 Extension: Month 7 to Month 12