A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily

• Register: EUCTR
• Last refreshed on: 21 August 2017
• Main ID: EUCTR2015-000922-12-FI
• Date of registration: 07/12/2015
• Prospective Registration: Yes
• Primary sponsor: Teva Pharmaceutical Industries, Ltd
• Public title: A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml daily
• Scientific title: 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® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE
• Date of first enrolment: 15/12/2015
• Target sample size: 840
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000922-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

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

Contacts

• Name: Clinical Trial Information Desk
• Affiliation: Teva GmbH

• Name: Clinical Trial Information Desk
• Affiliation: Teva GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
Patients may be included in the study only if they meet all of the following criteria:
a. Men or women at least 18 years of age or older
b. Patients must have a confirmed and documented RRMS diagnosis, as defined by the Revised
McDonald criteria (Polman et al 2011).
c. Patients must be ambulatory with a Kurtzke Expanded Disability Status Scale (EDSS) score of 0 to 5.5 at Screening visit.
d. Patients must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment (intravenous [IV], intramuscular [IM] and/or per os [PO]) or adrenocorticotrophic hormone (ACTH), 30 days prior to randomization.
e. Women of child-bearing potential must have a negative serum pregnancy test at screening visit and must practice a highly effective method of birth control. Highly effective methods of birth control are defined as those, alone or in combination, that result in a low failure rate (ie, less than 1% per year) when used consistently and correctly. Highly effective methods of birth control in this study include: combined (estrogen and progestogen containing) or progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, and sexual abstinence.
f. Patients must be able to sign and date a written informed consent prior to entering the study.
g. Patients must be willing and able to comply with the protocol requirements for the duration of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 756
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 84

Exclusion criteria:
Patients will be excluded from participating in this study if they meet any of the following
criteria:
a. Patient had any contraindication to Copaxone therapy.
b. Previous use of Copaxone 40 mg/mL TIW.
c. Patients with progressive forms of MS.
d. Patients with neuromyelitis optica.
e. Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
f. Patients who have been treated with:
- immunosuppressive medications such as azathioprine or methotrexate within 6 months prior
to the first visit
- immunoglobulins and/or monoclonal antibodies (including natalizumab) within at least
3 months prior to inclusion
- alemtuzumab, cladribine, cyclophosphamide or mitoxantrone at any time
g. Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid treatment within 6 months prior to screening visit.
h. Pregnancy or breastfeeding.
i. Clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation
j. Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 19.0 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Trade Name: Copaxone 20 mg/ml
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Not applicable
CAS Number: 147245-92-9
Current Sponsor code: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Trade Name: Copaxone 40 mg/ml
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Not applicable
CAS Number: 147245-92-9
Current Sponsor code: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-

Primary Outcome(s)

Primary end point(s): Primary Efficacy Endpoint(s):
- MSQ scores over 6 months of treatment.

Timepoint(s) of evaluation of this end point: Primary Efficacy Measure and Time Point: Medication satisfaction will be assessed with the MSQ at months 0 (baseline, except for treatment naïve patients), 1, 3, 6 (end of core phase), 9, and 12 (end of extension phase), and the ETD visit (if applicable). In addition MSQ will be SRFH on days 1 to 7.

Main Objective: 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 times a week (TIW) group and the Copaxone 20 mg/mL once daily (QD) group over 6 months of treatment.

Secondary Objective: The secondary objectives of the study are as follows:
- To compare the convenience perception as measured by the convenience scale within the Treatment Satisfaction Questionnaire for Medication (TSQM-9) in patients treated with subcutaneous (SC) injection of Copaxone 40 mg/mL TIW vs. Copaxone 20 mg/mL QD over 6 months of treatment
- To compare symptomatic changes as determined by the Multiple Sclerosis Quality of Life Inventory (MSQLI) subscales Modified Fatigue Impact Scale (MFIS) and Mental Health Inventory (MHI) in patients treated with SC injection of Copaxone 40 mg/mL TIW vs. Copaxone 20 mg/mL QD over 6 months of treatment
- To compare patient’s depressive symptoms as measured by Beck Depression Inventory II (BDI-II) scale in patients treated with SC injection of Copaxone 40 mg/mL TIW vs. Copaxone 20 mg/mL QD over 6 months of treatment

The exploratory and other objectives of the study are detailed in the study protocol.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Secondary Efficacy Measures:
- Convenience : months 0, 1, 3, 6, 9, and 12, ETD visit
- Symptomatic changes: months 0, 1, 3, 6, 9, and 12, ETD visit
- Depression: months 0, 1, 3, 6, 9, and 12, ETD visit

Safety Measures:
- inquiries about adverse events at every visit
- CBC at screening, and months 1, 3, and 6
- serum chemistry at screening, months 1, 3, and 6
- ß-hCG in women of child-bearing potential at screening.
- urine pregnancy test at months 0, 1, 3, 6, 9, and 12, ETD visit
- vital signs at every visit
- physical examinations at screening, month 6, 12 and ETD visit
- inquiries about concomitant medication usage at every visit

Exploratory and Ancillary Study Measures and Time Points are detailed in the study protocol.

Secondary end point(s): Secondary Efficacy Endpoints:
- Convenience perception as measured by the convenience scale within TSQM-9 over 6 months of treatment
- Symptomatic changes as determined by the MSQLI subscales MFIS and MHI over 6 months of
treatment
- Depressive symptoms as measured by BDI-II scale over 6 months of treatment

Exploratory Endpoints:
- Gene expression profiles of patients over 6 and 12 months of treatment (patients previously naïve to Copaxone only)
- Associations between genetics and selected clinical and exploratory endpoints over 6 and 12 months of treatment
- Retention rate at 6, 9, and 12 months.
- Adherence to treatment as measured by the MS-TAQ scale over 6 months of treatment
- For patients who use the CSYNC device, device satisfaction after 1, 6, and 12 months of treatment
- Evaluation of key variables at 9 and 12 months

Endpoints - Neuroimmunological Ancillary Study
- Cytokine profiles throughout the study.
- Distribution of T and B cells subpopulations as measured by flow cytometry, throughout the study.
- Levels of neurotrophic and gliotrophic factors (PDGF, NGF, BDNF, and eNRG1).

Safety Endpoints: Safety variables and endpoints will include the following:
- occurrence of adverse events throughout the study
- vital signs measurements at each visit
- clinical laboratory test results at screening, and months 1, 3, and 6

Assessment of Tolerability: Tolerability variables and endpoints are as follows:
-Proportion of patients (%) who prematurely discontinued from the study due to adverse events and the time to withdrawal.

Secondary ID(s)

2015-000922-12-BE

TV44400-CNS-40083

Source(s) of Monetary Support

Teva Pharmaceutical Industries, Ltd