Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis Treated With Copaxone® (CONFIDENCE)

Teva Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Multiple Sclerosis

Treatments: Drug: Copaxone®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02499900

2015-000922-12 (EudraCT Number)

TV44400-CNS-40083

Details and patient eligibility

About

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.

Enrollment: 861 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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861 participants in 2 patient groups

Copaxone® 40 mg/mL

Experimental group

Description:

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.

Treatment:

Drug: Copaxone®

Copaxone® 20 mg/mL

Active Comparator group

Description:

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.

Treatment:

Drug: Copaxone®