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

CompletadoFase 4ClinicalTrials.gov

ID: NCT02499900Tipo: INTERVENTIONALInicio: 10 de ago de 2015Fin estimado: 2 de jun de 2017

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Men or women at least 18 years of age or older.
Patients must have a confirmed and documented RRMS diagnosis
Patients must be ambulatory with a Kurtzke EDSS score of 0 to 5.5 at screening visit.
Patients must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment 30 days prior to randomization.
Women of child-bearing potential must have a negative urine pregnancy test at screening visit and must practice an acceptable method of birth
Patients must be able to sign and date a written informed consent prior to entering the study.
Patients must be willing and able to comply with the protocol requirements for the duration of the study.

Criterios de exclusión

Patient had any contraindication to Copaxone therapy.
Previous use of Copaxone 40 mg/mL three times per week.
Patients with progressive forms of MS.
Patients with neuromyelitis optica.
Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
Patients who have been treated with; immunosuppressive medications, immunoglobulins and/or monoclonal antibodies, alemtuzumab, cladribine, cyclophosphamide or mitoxantrone at any time
Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid treatment within 6 months prior to screening visit.
Pregnancy or breastfeeding.
Clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation
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

Intervenciones

drug

Copaxone®

Subcutaneous Injections

Ubicaciones

Teva Investigational Site 20061

Buenos Aires, Argentina

Teva Investigational Site 20062

Buenos Aires, Argentina

Teva Investigational Site 20063

Rosario, Argentina

Patrocinadores

PrincipalTeva Branded Pharmaceutical Products R&D, Inc.

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