CompletedPhase 3Relapsing MSNCT01874145

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Adjusted Mean Estimates for Injection-Related Adverse Event Rate Per Year in the Core PeriodRisk Ratio (RR) 0.5010.338–0.7430.0006

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

Compared with

Results by group

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

Day 1 to Month 4

GroupValueIntervalNumber analysed
GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)70.403 events per year11.995 (Standard Error)101
GA 40 mg/mL TIW (Core and Extension)35.275 events per year7.248 (Standard Error)108

GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)

70.403

GA 40 mg/mL TIW (Core and Extension)

35.275

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

GroupValueIntervalNumber analysed
Switchers: 40 mg/mL TIW (Extension)23.1 events per year31
Non-Switchers: GA 40 mg/mL TIW (Extension)28.0 events per year33

Switchers: 40 mg/mL TIW (Extension)

23.1

Non-Switchers: GA 40 mg/mL TIW (Extension)

28

Injection-Related Adverse Events in the Extension Period

Month 5 up to Month 10

GroupValueIntervalNumber analysed
Switchers: 40 mg/mL TIW (Extension)772 events31
Non-Switchers: GA 40 mg/mL TIW (Extension)979 events33

Switchers: 40 mg/mL TIW (Extension)

772

Non-Switchers: GA 40 mg/mL TIW (Extension)

979

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
GA 20 mg/mL QD (Core)1011 (1.0%)
GA 40 mg/mL TIW (Core)1082 (1.9%)
Switchers: 40 mg/mL TIW (Extension)970 (0.0%)
Non-Switchers: GA 40 mg/mL TIW (Extension)1012 (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 sleepSafety
  • Injection-Related Adverse Event Rate Per Year in the Extension Period

    Month 5 up to Month 10

    PainMood and sleepSafety
  • Injection-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 progressionRelapsesSafety
  • 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)

    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

    Safety
  • Injection Site Reaction Events in the Extension Period

    Month 5 up to Month 10

    Safety
  • 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)

    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

    1. Started

      Jun 2013

    2. Main results due

      Apr 2014

    3. Finished

      May 2014

    4. Results posted

      Jan 2016

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