Safety and Tolerability of Glatiramer Acetate

NCT01874145 | Completed Phase 3 Results

• 1 other identifier: GA-MS-303
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 35

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.

Conditions

Relapsing-Remitting Multiple Sclerosis

Keywords

Multiple Sclerosis; Relapsing-Remitting Multiple Sclerosis; Glatiramer Acetate; Glatiramer

Outcome Measures

Primary Outcomes (3)

• Adjusted Mean Estimates for Injection-Related Adverse Event Rate Per Year in the Core Period

  Injection-related (IR) adverse events refers to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria). Rate was calculated as # IR events/the total exposure to study drug in years. For cases in which more than 1 IR adverse event started on the same date for the same patient, these were counted as 1 IR adverse event for that patient. Parameter statistics were generated from a Poisson regression model with natural log of treatment duration (years) as an offset variable, and adjusted for baseline EDSS score, treatment group, age, sex, number of relapses in the 2 years prior to screening, in which a contrast comparing treatment groups were constructed. Adjusted mean estimates were adjusted estimates of event rates within treatment group.

  Day 1 to Month 4

• Injection-Related Adverse Event Rate Per Year in the Extension Period

  Injection-related (IR) adverse events refers to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria). Rate was calculated as # IR events/the total exposure to study drug in years. For cases in which more than 1 IR adverse event started on the same date for the same patient, these were counted as 1 IR adverse event for that patient.

  Month 5 up to Month 10

• Injection-Related Adverse Events in the Extension Period

  Injection-related (IR) adverse events refers to all local injection site reactions and/or symptoms or events related to immediate post injection reaction (flushing, chest pain, palpitations, anxiety, dyspnea, throat constriction, and/or urticaria).

  Month 5 up to Month 10

Secondary Outcomes (11)

• Adjusted Mean Estimates for Injection Site Reaction Event Rate Per Year in the Core Period

  Day 1 to Month 4

• Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Impact on Physical Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO) in the Core Period

  Month 0 (baseline), Months 1, 2, 4 (or early termination visit)

• Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Impact on Psychological Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO) in the Core Period

  Month 0 (baseline), Months 1, 2 4 (or early termination visit)

• Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Convenience Score in the Core Period

  Month 0 (baseline), Months 1, 2 4 (or early termination visit)

• Change From Baseline to Month 4 in in the Adjusted Mean Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Satisfaction Score in the Core Period

  Month 0 (baseline), Months 1, 2 4 (or early termination visit)

Other Outcomes (1)

• Percentage of Participants With Adverse Events Other Than Injection Related Reactions During the Core Period and the Extension Period

  Day 1 to Month 4 (core period); Month 5 to 10 (extension period)

Study Arms (2)

GA 20 mg/mL every day

ACTIVE COMPARATOR

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

Drug: GA 20 mg/mL

GA 40 mg/mL 3 times a week

EXPERIMENTAL

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.

Drug: GA 40 mg/mL

Interventions

GA 20 mg/mL 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.

Also known as: Glatiramer Acetate, Copaxone®

GA 20 mg/mL every day

GA 40 mg/mL 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.

Also known as: Glatiramer Acetate, Copaxone®

GA 40 mg/mL 3 times a week

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women at least 18 years of age or older
• 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
• Subjects must be ambulatory with a Kurtzke Expanded Disability Status Scale (EDSS) score of 0-5.5 in both the Screening and Baseline visits.
• 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.
• Subjects must be treated with Glatiramer Acetate (GA) 20mg/mL QD SC injection for a minimum of 6 months prior to screening.
• Women of child-bearing potential must practice an acceptable method of birth control \[acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptives, contraceptive patch, long-acting injectable contraceptive, partner's vasectomy or a double-barrier method (condom or diaphragm with spermicide)\].
• Subjects must be able to sign and date a written informed consent prior to entering the study.
• Subjects must be willing and able to comply with the protocol requirements for the duration of the study

You may not qualify if:

• Subject has any contraindication to Glatiramer Acetate therapy
• Subjects with progressive forms of multiple sclerosis (MS).
• Subjects with Neuromyelitis Optica (NMO).
• Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
• 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
• Previous use of mitoxantrone, cladribine, alemtuzumab, rituximab, natalizumab.
• Chronic (more than 30 consecutive days) systemic (IV, PO or IM) corticosteroid treatment within 6 months prior to screening visit.
• Previous total body irradiation or total lymphoid irradiation.
• Previous stem-cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
• Pregnancy or breastfeeding.
• 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.
• Subjects who underwent endovascular treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI).
• Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals -

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (35)

Teva Investigational Site 10706

Cullman, Alabama, United States

Location

Teva Investigational Site 10719

Gilbert, Arizona, United States

Location

Teva Investigational Site 10720

Phoenix, Arizona, United States

Location

Teva Investigational Site 10727

Fresno, California, United States

Location

Teva Investigational Site 10731

Long Beach, California, United States

Location

Teva Investigational Site 10735

Newport Beach, California, United States

Location

Teva Investigational Site 10712

Oceanside, California, United States

Location

Teva Investigational Site 10708

Centennial, Colorado, United States

Location

Teva Investigational Site 10715

Maitland, Florida, United States

Location

Teva Investigational Site 10718

Pompano Beach, Florida, United States

Location

Teva Investigational Site 10709

St. Petersburg, Florida, United States

Location

Teva Investigational Site 10707

Tampa, Florida, United States

Location

Teva Investigational Site 10711

Tampa, Florida, United States

Location

Teva Investigational Site 10710

Northbrook, Illinois, United States

Location

Teva Investigational Site 10734

Indianapolis, Indiana, United States

Location

Teva Investigational Site 10732

Baltimore, Maryland, United States

Location

Teva Investigational Site 10726

Great Falls, Montana, United States

Location

Teva Investigational Site 10702

Henderson, Nevada, United States

Location

Teva Investigational Site 10717

Patchogue, New York, United States

Location

Teva Investigational Site 10723

Plainview, New York, United States

Location

Teva Investigational Site 10716

Charlotte, North Carolina, United States

Location

Teva Investigational Site 10724

Raleigh, North Carolina, United States

Location

Teva Investigational Site 10721

Winston-Salem, North Carolina, United States

Location

Teva Investigational Site 10733

Bellevue, Ohio, United States

Location

Teva Investigational Site 10703

Columbus, Ohio, United States

Location

Teva Investigational Site 10714

Dayton, Ohio, United States

Location

Teva Investigational Site 10704

Uniontown, Ohio, United States

Location

Teva Investigational Site 10725

East Providence, Rhode Island, United States

Location

Teva Investigational Site 10736

Cordova, Tennessee, United States

Location

Teva Investigational Site 10701

Franklin, Tennessee, United States

Location

Teva Investigational Site 10728

Nashville, Tennessee, United States

Location

Teva Investigational Site 10729

Mansfield, Texas, United States

Location

Teva Investigational Site 10722

Round Rock, Texas, United States

Location

Teva Investigational Site 10699

Salt Lake City, Utah, United States

Location

Teva Investigational Site 10700

Roanoke, Virginia, United States

Location

Related Publications (1)

• 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.

  PMID: 26195058 RESULT

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

Glatiramer Acetate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

ustevatrials@tevapharm.com

215-591-3000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2013
• First Posted: June 10, 2013
• Study Start: June 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: January 14, 2016
• Results First Posted: January 14, 2016

Record last verified: 2015-12

Locations

US (35)