EUCTR2015-000922-12-FIActive, not recruitingPhase 1
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
Teva Pharmaceutical Industries, Ltd0 sites840 target enrollmentStarted: December 7, 2015Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 840
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
Investigators
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