Safety and Tolerability of Glatiramer Acetate

NCT ID: NCT01874145

Last Updated: 2016-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 209 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-05-31

Brief Summary

This is an open-label, randomized, multi-center, parallel-arm study to assess the safety and tolerability of a daily dose of Glatiramer Acetate (GA) 40 mg/mL three times a week (TIW) administered subcutaneously (SC) as compared to GA 20 mg/mL every day (QD) administered SC.

Detailed Description

The study will comprise of a Core study and an Extension phase. During the Core study, subjects will be evaluated at study sites for 5 scheduled visits at Months: -1 (Screening), 0 (Baseline), 1, 2, and 4 (Termination/Early Termination). Subjects who complete all scheduled visits will have final procedures and assessments performed at the final visit (Month 4, Termination visit). Subjects who withdraw from the study before completing the 4 months evaluation period will have Early Termination (ET) procedures and assessments performed at their final visit.

During the Extension phase, all subjects will be offered to continue treatment with GA 40 mg/mL TIW. Subjects will be evaluated every 4 months until this dose strength is commercially available for the treatment of Relapsing-Remitting Multiple Sclerosis (RRMS) patients or until the development of this GA dose regimen is stopped by the Sponsor, the last visit of this phase will be called Termination/ET-Extension visit.

Conditions

Relapsing-Remitting Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GA 20 mg/mL every day

Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core study.

Group Type: ACTIVE_COMPARATOR

GA 20 mg/mL

Intervention Type: DRUG

Glatiramer acetate (GA) 20 mg/mL subcutaneous (SC) injection, the commercial product, is a single-use pre-filled syringe (PFS) containing 1.0 ml of a clear, colorless to slightly yellow, sterile, non-pyrogenic solution.

GA 40 mg/mL 3 times a week

Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core study.

During the Extension period, all participants to continue treatment with GA 40 mg/mL TIW until this dose regimen is commercially available for the treatment of RRMS patients.

Group Type: EXPERIMENTAL

GA 40 mg/mL

Intervention Type: DRUG

Glatiramer acetate (GA) 40 mg/mL subcutaneous (SC) injection, is a single-use pre-filled syringe (PFS) containing 1.0 ml of a clear, colorless to slightly yellow, sterile, non-pyrogenic solution.

Interventions

GA 20 mg/mL

Glatiramer acetate (GA) 20 mg/mL subcutaneous (SC) injection, the commercial product, is a single-use pre-filled syringe (PFS) containing 1.0 ml of a clear, colorless to slightly yellow, sterile, non-pyrogenic solution.

Intervention Type: DRUG

GA 40 mg/mL

Glatiramer acetate (GA) 40 mg/mL subcutaneous (SC) injection, is a single-use pre-filled syringe (PFS) containing 1.0 ml of a clear, colorless to slightly yellow, sterile, non-pyrogenic solution.

Intervention Type: DRUG

Other Intervention Names

Glatiramer Acetate; Copaxone®; Glatiramer Acetate; Copaxone®

Eligibility Criteria

Inclusion Criteria

1. Men or women at least 18 years of age or older

2. Subjects must have a confirmed and documented RRMS diagnosis as defined by the Revised McDonald criteria, with relapse onset disease or a relapsing-remitting disease course

3. Subjects must be ambulatory with a Kurtzke Expanded Disability Status Scale (EDSS) score of 0-5.5 in both the Screening and Baseline visits.

4. Subjects must be in a stable neurological condition, relapse-free and free of any corticosteroid treatment [intravenous (IV), intramuscular (IM) and/or per os (PO)] or adrenocorticotrophic hormone (ACTH), 60 days prior to randomization.

5. Subjects must be treated with Glatiramer Acetate (GA) 20mg/mL QD SC injection for a minimum of 6 months prior to screening.

6. Women of child-bearing potential must practice an acceptable method of birth control [acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptives, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy or a double-barrier method (condom or diaphragm with spermicide)].

7. Subjects must be able to sign and date a written informed consent prior to entering the study.

8. Subjects must be willing and able to comply with the protocol requirements for the duration of the study

Exclusion Criteria

1. Subject has any contraindication to Glatiramer Acetate therapy

2. Subjects with progressive forms of multiple sclerosis (MS).

3. Subjects with Neuromyelitis Optica (NMO).

4. Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.

5. Concomitant use of other disease modifying drug for MS ((Fingolimod (Gilenya®), dimethyl fumarate (Tecfidera®), Teriflunomide (Aubagio®) or intravenous immunoglobulin (IVIG)) within 6 months prior to screening

6. Previous use of mitoxantrone, cladribine, alemtuzumab, rituximab, natalizumab.

7. Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid treatment within 6 months prior to screening visit.

8. Previous total body irradiation or total lymphoid irradiation.

9. Previous stem-cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.

10. Pregnancy or breastfeeding.

11. Subjects with a clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation, as determined by medical history, physical exams, ECG and abnormal laboratory tests. Such conditions may include hepatic, renal or metabolic diseases, systemic disease, acute infection, current malignancy or recent history (5 years) of malignancy, major psychiatric disorder, history of drug and/or alcohol abuse and allergies that could be detrimental according to the investigator's judgment.

12. Subjects who underwent endovascular treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI).

13. Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Teva Investigational Site 10706

Cullman, Alabama, United States

Teva Investigational Site 10719

Gilbert, Arizona, United States

Teva Investigational Site 10720

Phoenix, Arizona, United States

Teva Investigational Site 10727

Fresno, California, United States

Teva Investigational Site 10731

Long Beach, California, United States

Teva Investigational Site 10735

Newport Beach, California, United States

Teva Investigational Site 10712

Oceanside, California, United States

Teva Investigational Site 10708

Centennial, Colorado, United States

Teva Investigational Site 10715

Maitland, Florida, United States

Teva Investigational Site 10718

Pompano Beach, Florida, United States

Teva Investigational Site 10709

St. Petersburg, Florida, United States

Teva Investigational Site 10707

Tampa, Florida, United States

Teva Investigational Site 10711

Tampa, Florida, United States

Teva Investigational Site 10710

Northbrook, Illinois, United States

Teva Investigational Site 10734

Indianapolis, Indiana, United States

Teva Investigational Site 10732

Baltimore, Maryland, United States

Teva Investigational Site 10726

Great Falls, Montana, United States

Teva Investigational Site 10702

Henderson, Nevada, United States

Teva Investigational Site 10717

Patchogue, New York, United States

Teva Investigational Site 10723

Plainview, New York, United States

Teva Investigational Site 10716

Charlotte, North Carolina, United States

Teva Investigational Site 10724

Raleigh, North Carolina, United States

Teva Investigational Site 10721

Winston-Salem, North Carolina, United States

Teva Investigational Site 10733

Bellevue, Ohio, United States

Teva Investigational Site 10703

Columbus, Ohio, United States

Teva Investigational Site 10714

Dayton, Ohio, United States

Teva Investigational Site 10704

Uniontown, Ohio, United States

Teva Investigational Site 10725

East Providence, Rhode Island, United States

Teva Investigational Site 10736

Cordova, Tennessee, United States

Teva Investigational Site 10701

Franklin, Tennessee, United States

Teva Investigational Site 10728

Nashville, Tennessee, United States

Teva Investigational Site 10729

Mansfield, Texas, United States

Teva Investigational Site 10722

Round Rock, Texas, United States

Teva Investigational Site 10699

Salt Lake City, Utah, United States

Teva Investigational Site 10700

Roanoke, Virginia, United States

Countries

United States

References

Wolinsky JS, Borresen TE, Dietrich DW, Wynn D, Sidi Y, Steinerman JR, Knappertz V, Kolodny S; GLACIER Study Group. GLACIER: An open-label, randomized, multicenter study to assess the safety and tolerability of glatiramer acetate 40 mg three-times weekly versus 20 mg daily in patients with relapsing-remitting multiple sclerosis. Mult Scler Relat Disord. 2015 Jul;4(4):370-6. doi: 10.1016/j.msard.2015.06.005. Epub 2015 Jun 14.

Reference Type: RESULT

PMID: 26195058 (View on PubMed)

Other Identifiers

GA-MS-303

Identifier Type: -

Identifier Source: org_study_id