Phase 3 N=209 Randomized Treatment

Safety and Tolerability of Glatiramer Acetate

Relapsing-Remitting Multiple Sclerosis

Bottom Line

View on ClinicalTrials.gov: NCT01874145 ↗

Enrolled (actual)

209

Serious AEs

1.2%

Results posted

Jan 2016

Primary outcome: Primary: Adjusted Mean Estimates for Injection-Related Adverse Event Rate Per Year in the Core Period — 70.403; 35.275 events per year — p=0.0006

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: GA 20 mg/mL (Drug); GA 40 mg/mL (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Primary completion: Apr 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Adjusted Mean Estimates for Injection-Related Adverse Event Rate Per Year in the Core Period	70.403; 35.275	0.0006 sig
PRIMARY Injection-Related Adverse Event Rate Per Year in the Extension Period	23.1; 28.0	—
PRIMARY Injection-Related Adverse Events in the Extension Period	772; 979	—
SECONDARY Adjusted Mean Estimates for Injection Site Reaction Event Rate Per Year in the Core Period	70.392; 35.200	0.0006 sig
SECONDARY 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	1.536; -0.522	0.0897
SECONDARY 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	0.738; 0.016	—
SECONDARY 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	1.745; 8.751	—
SECONDARY 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	1.555; 0.703	—
SECONDARY Injection Site Reaction Event Rate Per Year in the Extension Period	22.9; 28.0	—
SECONDARY Injection Site Reaction Events in the Extension Period	768; 976	—
SECONDARY Change From Start of Extension Period (Month 4) to Month 8 (and to Endpoint Visit) in the Participant-Reported Impact on Physical Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO)	-0.6; 0.8; 1.1; 0.6	—
SECONDARY Change From Start of Extension Period (Month 4) to Month 8 (and to Endpoint Visit) in the Participant-Reported Impact on Psychological Wellbeing Using Multiple Sclerosis Impact Scale (MSIS-29 PRO)	1.2; 0.4; 0.9; 0.2	—
SECONDARY Change From Start of Extension Period to Month 8 (and to Endpoint Visit) in in the Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Convenience Score	4.0; -0.2; 4.3; -0.2	—
SECONDARY Change From Start of Extension Period to Month 8 (and to Endpoint Visit) in in the Participant-Reported Treatment Satisfaction Questionnaire for Medication (TSQM-9) Satisfaction Score	-0.3; -1.2; -0.0; -1.2	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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 -

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Data sourced from ClinicalTrials.gov (NCT01874145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.