GLACIER
What it found
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Adjusted Mean Estimates for Injection-Related Adverse Event Rate Per Year in the Core Period | Risk Ratio (RR) 0.501 | 0.338–0.743 | 0.0006 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Glatiramer acetate
Unknown
Compared with
- Glatiramer acetate
Unknown
Results by group
Adjusted Mean Estimates for Injection-Related Adverse Event Rate Per Year in the Core Period
Day 1 to Month 4
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension) | 70.403 events per year | 11.995 (Standard Error) | 101 |
| GA 40 mg/mL TIW (Core and Extension) | 35.275 events per year | 7.248 (Standard Error) | 108 |
GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)
GA 40 mg/mL TIW (Core and Extension)
p = 0.0006; Risk Ratio (RR) 0.501 (95% CI 0.338–0.743)
Injection-Related Adverse Event Rate Per Year in the Extension Period
Month 5 up to Month 10
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Switchers: 40 mg/mL TIW (Extension) | 23.1 events per year | 31 | |
| Non-Switchers: GA 40 mg/mL TIW (Extension) | 28.0 events per year | 33 |
Switchers: 40 mg/mL TIW (Extension)
Non-Switchers: GA 40 mg/mL TIW (Extension)
Injection-Related Adverse Events in the Extension Period
Month 5 up to Month 10
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Switchers: 40 mg/mL TIW (Extension) | 772 events | 31 | |
| Non-Switchers: GA 40 mg/mL TIW (Extension) | 979 events | 33 |
Switchers: 40 mg/mL TIW (Extension)
Non-Switchers: GA 40 mg/mL TIW (Extension)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| GA 20 mg/mL QD (Core) | 101 | 1 (1.0%) | |
| GA 40 mg/mL TIW (Core) | 108 | 2 (1.9%) | |
| Switchers: 40 mg/mL TIW (Extension) | 97 | 0 (0.0%) | |
| Non-Switchers: GA 40 mg/mL TIW (Extension) | 101 | 2 (2.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Adjusted Mean Estimates for Injection-Related Adverse Event Rate Per Year in the Core Period
Day 1 to Month 4
Disability progressionRelapsesPainMood and sleepSafetyInjection-Related Adverse Event Rate Per Year in the Extension Period
Month 5 up to Month 10
PainMood and sleepSafetyInjection-Related Adverse Events in the Extension Period
Month 5 up to Month 10
PainMood and sleepSafety
Other measures (11)
Adjusted Mean Estimates for Injection Site Reaction Event Rate Per Year in the Core Period
Day 1 to Month 4
Disability progressionRelapsesSafetyChange 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)
Quality of life (reported by participants)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)
Quality of life (reported by participants)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)
Quality of life (reported by participants)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)
Quality of life (reported by participants)Injection Site Reaction Event Rate Per Year in the Extension Period
Month 5 up to Month 10
SafetyInjection Site Reaction Events in the Extension Period
Month 5 up to Month 10
SafetyChange 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)
Month 4 (baseline for extension period), Month 8, endpoint visit
Quality of life (reported by participants)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)
Month 4 (baseline for extension period), Month 8, endpoint visit
Quality of life (reported by participants)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
Month 4 (baseline for extension period), Month 8, endpoint visit
Quality of life (reported by participants)
Who could take part
Relapsing MS · 18 and over
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 -
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
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History
Started
Jun 2013
Main results due
Apr 2014
Finished
May 2014
Results posted
Jan 2016
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