A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug).

• Register: EUCTR
• Last refreshed on: 25 March 2013
• Main ID: EUCTR2011-005550-57-LV
• Date of registration: 09/02/2012
• Prospective Registration: Yes
• Primary sponsor: Teva Pharmaceutical Industries Ltd.
• Public title: A clinical study in patients with multiple sclerosis to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml (experimental drug).
• Scientific title: A multinational, multicenter, randomized, parallel group, double blind, placebo controlled study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) 20 mg/0.5 ml new formulation administered daily by subcutaneous (SC) injection. - GLOW study
• Date of first enrolment: 15/05/2012
• Target sample size: 1400
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005550-57
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Albania, Belarus, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Estonia, Georgia, Germany, Greece, Hungary, Latvia, Lithuania, Macedonia, the former Yugoslav Republic of, Mexico, Moldova, Republic of, Montenegro, Poland, Romania, Russian Federation, Serbia, Ukraine, United States

Contacts

• Name: Clinical trial information desk
• Affiliation: Teva Pharma GmbH

• Name: Clinical trial information desk
• Affiliation: Teva Pharma GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
1.Subjects must have a confirmed and documented MS diagnosis as defined by the Revised McDonald criteria, with a relapsing-remitting disease course.
2.Subjects must be ambulatory with an EDSS score of 0-5.5 in both screening and baseline visits.
3.Subjects must be in a relapse-free, stable neurological condition and free of corticosteroid treatment or ACTH, 30 days prior to screening (Month -1) and between screening and baseline (Month 0) visits.
4.Subjects must have experienced one of the following:
• At least one documented relapse in the 12 months prior to screening, or
• At least two documented relapses in the 24 months prior to screening, or
• One documented relapse between 12 and 24 months prior to screening with at least one documented T1-Gd enhancing lesion in an MRI performed within 12 months prior to screening.
5.Subjects must be between 18 and 55 years of age, inclusive.
6.Women of child-bearing potential must practice an acceptable method of birth control.
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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Subjects with progressive forms of MS.
2. Use of experimental or investigational drugs, and/or participation in drug clinical studies within the 6 months prior to screening.
3. Use of immunosuppressive (including Mitoxantrone and Fingolimod) or cytotoxic agents within 6 months prior to the screening visit.
4. Use of natalizumab (Tysabri®) or any other monoclonal antibodies within 2 years prior to screening.
5. Use of cladribine within 2 years prior to screening.
6. Previous treatment with immunomodulators within 2 months prior to screening.
7. Previous use of GA or any other glatiramoid.
8. Chronic systemic corticosteroid treatment within 6 months prior to screening visit.
9. Previous total body irradiation or total lymphoid irradiation.
10. Previous stem-cell treatment, autologous bone marrow transplantation or allogenic bone marrow transplantation.
11. Pregnancy or breastfeeding.
12. 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, abnormal laboratory tests and chest X-ray. 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.
13. A known history of sensitivity to Gadolinium.
14. GFR = 60 mL/min/ 1.73m2 at the screening visit
15. Inability to successfully undergo MRI scanning.
16. A known drug hypersensitivity to Mannitol.
17. Subjects who underwent endovascular treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI).



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Relapsing-remitting Multiple sclerosis (RRMS)
MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Product Name: 20mg/0.5ml glatiramer acetate
Product Code: 20mg/0.5ml GA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: glatiramer acetate
CAS Number: 147245-92-9
Current Sponsor code: 20 mg/0.5 ml GA
Other descriptive name: glatiramer acetate
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): The total number of confirmed relapses during the 12 months PC phase. This will be used to calculate the Annual Relapse Rate during the PC phase per each arm.

Timepoint(s) of evaluation of this end point: Relapses will be confirmed/monitored throughout the study.

Main Objective: To assess the effect of Glatiramer Acetate (GA) injection 20 mg/0.5 ml administered daily compared to placebo in subjects with RRMS on the total number of confirmed relapses during the 12 month PC phase. This will be used to calculate the Annualized Relapse Rate during the PC phase per each arm.

Secondary Objective: To assess the effect of GA injection 20 mg/0.5ml administered daily compared to placebo in subjects with RRMS:
- on the cumulative number of new/enlarging T2 lesions measured at Months 6 and 12 (end of PC phase).
- on the cumulative number of Gd-enhancing lesions on T1-weighted images measured at Months 6 and 12 (end of PC phase).
- on the development of brain atrophy as defined by the percent brain volume change from baseline to Month 12 (end of PC phase).

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Following GFR evaluation, all subjects will undergo MRI scans at months 0 (13-7 days prior to baseline visit), Month 6 and Month 12 (end of PC phase) or ET. During an unscheduled visit the investigator will decide if an MRI scan is required.
- The cumulative number of new/enlarging T2 lesions measured at Months 6 and 12 (end of PC phase).
- The cumulative number of Gd-enhancing lesions on T1-weighted images measured at Months 6 and 12 (End of the PC phase).
-The percent brain volume change from baseline to Month 12 (end of PC phase).

Secondary end point(s): - cumulative number of new/enlarging T2 lesions measured at Months 6 and 12 (End of the PC phase)
- cumulative number of Gd-enhancing lesions on T1-weighted images measured at Month
- percent brain volume change from baseline to Month 12 (end of PC phase).

Secondary ID(s)

GA-MS-302

Source(s) of Monetary Support

Teva Pharmaceutical Industries Ltd