CONFIDENCECONFIDENCE: 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
Copaxone®
Autoimmune Diseases+4
+ Demyelinating Diseases
+ Immune System Diseases
Treatment Study
Summary
Study start date: August 10, 2015
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.861 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 97 locations
Teva Investigational Site 13485
Cullman, United StatesOpen Teva Investigational Site 13485 in Google MapsTeva Investigational Site 13524
Carmichael, United StatesTeva Investigational Site 13478
Atlanta, United StatesTeva Investigational Site 13475
Northbrook, United States