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

• Register: ClinicalTrials.gov
• Last refreshed on: 21 December 2021
• Main ID: NCT02499900
• Date of registration: 01/07/2015
• Prospective Registration: Yes
• Primary sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Public title: 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 CONFIDENCE
• Scientific title: 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
• Date of first enrolment: August 10, 2015
• Target sample size: 861
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02499900
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Argentina, Austria, Belgium, Croatia, Finland, France, Germany, Ireland, Italy, Mexico, Poland, Puerto Rico, Russian Federation, Spain, Turkey, United States

Contacts

• Name: Teva Medical Expert, MD
• Affiliation: Teva Branded Pharmaceutical Products R&D, Inc.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Copaxone®

Primary Outcome(s)

Change From Baseline in the Medication Satisfaction Questionnaire (MSQ) to Month 6 Using a Repeated Measures ANCOVA [Time Frame: Baseline (Month 0), Months 1, 3 and 6]

Secondary Outcome(s)

Change From Baseline in the Treatment Satisfaction Questionnaire for Medication 9-item Version (TSQM-9) Convenience Score to Month 6 Using a Repeated Measures ANCOVA [Time Frame: Baseline (Month 0), Months 1, 3 and 6]

Change From Baseline in the Beck Depression Inventory II (BDI-II) Total Score to Month 6 Using a Repeated Measures ANCOVA [Time Frame: Baseline (Month 0), Months 1, 3 and 6]

Participants With Treatment-Emergent Adverse Events (TEAEs) During Both the Core Period and Extension Periods [Time Frame: Core: Day 1 to Month 6 Extension: Month 7 to Month 12]

Change From Baseline in the Mental Health Index (MHI) Total Score and Subscales to Month 6 Using a Repeated Measures ANCOVA [Time Frame: Baseline (Month 0), Months 1, 3 and 6]

Change From Baseline in the Modified Fatigue Impact Scale (MFIS) Total Score and Subscales to Month 6 Using a Repeated Measures ANCOVA [Time Frame: Baseline (Month 0), Months 1, 3 and 6]

Secondary ID(s)

TV44400-CNS-40083

2015-000922-12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 20/08/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02499900