Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Copaxone®

Drug
Who is being recruted

Autoimmune Diseases+4

+ Demyelinating Diseases

+ Immune System Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: August 2015
See protocol details

Summary

Principal SponsorTeva Branded Pharmaceutical Products R&D, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleCONFIDENCE: 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
NCT02499900
Principal SponsorTeva Branded Pharmaceutical Products R&D, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

861 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Autoimmune DiseasesDemyelinating DiseasesImmune System DiseasesMultiple SclerosisNervous System DiseasesAutoimmune Diseases of the Nervous SystemDemyelinating Autoimmune Diseases, CNS

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.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Subcutaneous Injections 20 mg/mL Daily for the core period which last 6 months. In the extension period patient are administered Copaxone® 40 mg/mL for months 7 - 12.

Group II

Experimental
Subcutaneous Injections 40 mg/mL Three Times a Week for the core period which last 6 months. In the extension period patient are administered Copaxone® 40 mg/mL for months 7 - 12.

Study 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

Suspended

Teva Investigational Site 13485

Cullman, United StatesOpen Teva Investigational Site 13485 in Google Maps
Suspended

Teva Investigational Site 13524

Carmichael, United States
Suspended

Teva Investigational Site 13478

Atlanta, United States
Suspended

Teva Investigational Site 13475

Northbrook, United States
Completed97 Study Centers