Clinical trial NCT02499900: Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis Treated With Copaxone®
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2015-07-16
Enrollment: 861
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in the Medication Satisfaction Questionnaire (MSQ) to Month 6 Using a Repeated Measures ANCOVA
timeFrame: Baseline (Month 0), Months 1, 3 and 6
Secondary outcomes:
measure: 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
timeFrame: Baseline (Month 0), Months 1, 3 and 6
measure: Change From Baseline in the Modified Fatigue Impact Scale (MFIS) Total Score and Subscales to Month 6 Using a Repeated Measures ANCOVA
timeFrame: Baseline (Month 0), Months 1, 3 and 6
measure: Change From Baseline in the Mental Health Index (MHI) Total Score and Subscales to Month 6 Using a Repeated Measures ANCOVA
timeFrame: Baseline (Month 0), Months 1, 3 and 6
measure: Change From Baseline in the Beck Depression Inventory II (BDI-II) Total Score to Month 6 Using a Repeated Measures ANCOVA
timeFrame: Baseline (Month 0), Months 1, 3 and 6
measure: Participants With Treatment-Emergent Adverse Events (TEAEs) During Both the Core Period and Extension Periods
timeFrame: Core: Day 1 to Month 6 Extension: Month 7 to Month 12
Other outcomes:
Locations:
city: Cullman
country: United States
facility: Teva Investigational Site 13485
state: Alabama
city: Carmichael
country: United States
facility: Teva Investigational Site 13524
state: California
city: Atlanta
country: United States
facility: Teva Investigational Site 13478
state: Georgia
city: Northbrook
country: United States
facility: Teva Investigational Site 13475
state: Illinois
city: Foxboro
country: United States
facility: Teva Investigational Site 13472
state: Massachusetts
city: Golden Valley
country: United States
facility: Teva Investigational Site 13479
state: Minnesota
city: Golden Valley
country: United States
facility: Teva Investigational Site 13483
state: Minnesota
city: Las Vegas
country: United States
facility: Teva Investigational Site 13487
state: Nevada
city: Teaneck
country: United States
facility: Teva Investigational Site 13470
state: New Jersey
city: New Hyde Park
country: United States
facility: Teva Investigational Site 13482
state: New York
city: Raleigh
country: United States
facility: Teva Investigational Site 13471
state: North Carolina
city: Columbus
country: United States
facility: Teva Investigational Site 13473
state: Ohio
city: Uniontown
country: United States
facility: Teva Investigational Site 13477
state: Ohio
city: Round Rock
country: United States
facility: Teva Investigational Site 13481
state: Texas
city: Virginia Beach
country: United States
facility: Teva Investigational Site 13480
state: Virginia
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 20061
city: Buenos Aires
country: Argentina
facility: Teva Investigational Site 20062
city: Rosario
country: Argentina
facility: Teva Investigational Site 20063
city: Wien
country: Austria
facility: Teva Investigational Site 33040
city: Bruxelles
country: Belgium
facility: Teva Investigational Site 37066
city: Edegem
country: Belgium
facility: Teva Investigational Site 37063
city: Rijeka
country: Croatia
facility: Teva Investigational Site 60037
city: Slavonski Brod
country: Croatia
facility: Teva Investigational Site 60039
city: Zagreb
country: Croatia
facility: Teva Investigational Site 60034
city: Zagreb
country: Croatia
facility: Teva Investigational Site 60035
city: Zagreb
country: Croatia
facility: Teva Investigational Site 60036
city: Zagreb
country: Croatia
facility: Teva Investigational Site 60040
city: Tampere
country: Finland
facility: Teva Investigational Site 40014
city: Turku
country: Finland
facility: Teva Investigational Site 40015
city: Besancon
country: France
facility: Teva Investigational Site 35211
city: Bordeaux
country: France
facility: Teva Investigational Site 35203
city: Bron Cedex
country: France
facility: Teva Investigational Site 35207
city: Clermont-Ferrand
country: France
facility: Teva Investigational Site 35210
city: Lille
country: France
facility: Teva Investigational Site 35208
city: Lomme
country: France
facility: Teva Investigational Site 35214
city: Nancy
country: France
facility: Teva Investigational Site 35204
city: Nice
country: France
facility: Teva Investigational Site 35205
city: Nimes
country: France
facility: Teva Investigational Site 35206
city: Nimes
country: France
facility: Teva Investigational Site 35212
city: Poissy
country: France
facility: Teva Investigational Site 35213
city: Rennes
country: France
facility: Teva Investigational Site 35202
city: Strasbourg
country: France
facility: Teva Investigational Site 35201
city: Toulouse
country: France
facility: Teva Investigational Site 35209
city: Bayreuth
country: Germany
facility: Teva Investigational Site 32605
city: Dresden
country: Germany
facility: Teva Investigational Site 32603
city: Hamburg
country: Germany
facility: Teva Investigational Site 32602
city: Rostock
country: Germany
facility: Teva Investigational Site 32606
city: Stuttgart
country: Germany
facility: Teva Investigational Site 32604
city: Dublin
country: Ireland
facility: Teva Investigational Site 44029
city: Bari
country: Italy
facility: Teva Investigational Site 30169
city: Genova
country: Italy
facility: Teva Investigational Site 30163
city: Milano
country: Italy
facility: Teva Investigational Site 30165
city: Milano
country: Italy
facility: Teva Investigational Site 30164
city: Montichiari
country: Italy
facility: Teva Investigational Site 30161
city: Naples
country: Italy
facility: Teva Investigational Site 30167
city: Rome
country: Italy
facility: Teva Investigational Site 30166
city: Rome
country: Italy
facility: Teva Investigational Site 30162
city: DF
country: Mexico
facility: Teva Investigational Site 21096
city: Mexico City
country: Mexico
facility: Teva Investigational Site 21097
city: Mexico City
country: Mexico
facility: Teva Investigational Site 21095
city: Mexico City
country: Mexico
facility: Teva Investigational Site 21098
city: Bydgoszcz
country: Poland
facility: Teva Investigational Site 53352
city: Gdansk
country: Poland
facility: Teva Investigational Site 53354
city: Katowice
country: Poland
facility: Teva Investigational Site 53350
city: Kielce
country: Poland
facility: Teva Investigational Site 53349
city: Konskie
country: Poland
facility: Teva Investigational Site 53353
city: Lodz
country: Poland
facility: Teva Investigational Site 53356
city: Lodz
country: Poland
facility: Teva Investigational Site 53348
city: Lublin
country: Poland
facility: Teva Investigational Site 53345
city: Olsztyn
country: Poland
facility: Teva Investigational Site 53355
city: Rybnik
country: Poland
facility: Teva Investigational Site 53351
city: Rzeszow
country: Poland
facility: Teva Investigational Site 53347
city: Warszawa
country: Poland
facility: Teva Investigational Site 53346
city: Guaynabo
country: Puerto Rico
facility: Teva Investigational Site 13476
city: Kaluga
country: Russian Federation
facility: Teva Investigational Site 50392
city: Kazan
country: Russian Federation
facility: Teva Investigational Site 50390
city: Krasnoyarsk
country: Russian Federation
facility: Teva Investigational Site 50391
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 50387
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 50374
city: Moscow
country: Russian Federation
facility: Teva Investigational Site 50373
city: Novosibirsk
country: Russian Federation
facility: Teva Investigational Site 50376
city: Perm
country: Russian Federation
facility: Teva Investigational Site 50389
city: St. Petersburg
country: Russian Federation
facility: Teva Investigational Site 50377
city: St. Petersburg
country: Russian Federation
facility: Teva Investigational Site 50375
city: Tyumen
country: Russian Federation
facility: Teva Investigational Site 50372
city: Yaroslavl
country: Russian Federation
facility: Teva Investigational Site 50378
city: Burgos
country: Spain
facility: Teva Investigational Site 31181
city: El Palmar
country: Spain
facility: Teva Investigational Site 31179
city: Madrid
country: Spain
facility: Teva Investigational Site 31180
city: Malaga
country: Spain
facility: Teva Investigational Site 31177
city: Sevilla
country: Spain
facility: Teva Investigational Site 31182
city: Sevilla
country: Spain
facility: Teva Investigational Site 31184
city: Valencia
country: Spain
facility: Teva Investigational Site 31178
city: Ankara
country: Turkey
facility: Teva Investigational Site 82052
city: Istanbul
country: Turkey
facility: Teva Investigational Site 82051
city: Istanbul
country: Turkey
facility: Teva Investigational Site 82049
city: Kocaeli
country: Turkey
facility: Teva Investigational Site 82050
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References:
citation: 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.