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

Phase 1

• Conditions: Relapsing-Remitting Multiple Sclerosis (RRMS); MedDRA version: 20.0Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-000922-12-IT
• Lead Sponsor: TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-28
• Last Update Posted: 12 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 840

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: 1
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified