A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug).

• Register: EUCTR
• Last refreshed on: 3 July 2017
• Main ID: EUCTR2009-018084-27-HU
• Date of registration: 01/03/2010
• Prospective Registration: Yes
• Primary sponsor: Teva Pharmaceutical Industries, Ltd.
• Public title: A clinical study to find out whether Copaxone (glatiramer acetate 40mg/ 1 ml), injected three times a week, is effective and safe for the treatment of multiple sclerosis. The safety and efficacy of Copaxone is compared to placebo (control treatment without therapeutically active drug).
• Scientific title: A multinational, multicenter, randomized, parallel-group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in a double-blind design. - GALA
• Date of first enrolment: 30/03/2010
• Target sample size: 1350
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-018084-27
• 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Bulgaria, Croatia, Czech Republic, Estonia, Georgia, Germany, Hungary, Israel, Italy, Lithuania, Poland, Romania, Russian Federation, South Africa, Ukraine, United Kingdom, United States

Contacts

• Name: Dr. Ekkehard Baader
• Affiliation: Teva Pharma GmbH

• Name: Dr. Ekkehard Baader
• 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 [Ann Neurol 2005: 58:840-846], 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 [intravenous (IV), intramuscular (IM) and/or per os (PO)] or ACTH (Adrenocorticotropic hormone) 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 [acceptable methods of birth control in this study include: surgical sterilization, intrauterine devices, oral contraceptive, 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.
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 1350
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 agents (including Mitoxantrone and Fingolimod) or cytotoxic agents within 6 months prior to the screening.
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 [including IFNß 1a and 1b, and IV Immunoglobulin (IVIg)] within 2 months prior to screening.
7. Previous use of GA or any other glatiramoid.
8. Chronic (more than 30 consecutive days) systemic (IV, PO or IM) 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. Inability to successfully undergo MRI scanning.
15. A known drug hypersensitivity to Mannitol.
16. Subjects who underwent endovascular treatment for Chronic Cerebrospinial Venous Insufficiency (CCSVI).


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

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Relapsing-remitting Multiple Sclerosis (RR MS)
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: 40 mg glatiramer acetate
Product Code: 40 mg GA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: glatiramer acetate
CAS Number: 147245-92-9
Current Sponsor code: 40 mg GA
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)

Main Objective: To assess the efficacy of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo in subjects with RRMS, as measured by the number of confirmed relapses during the 12 months placebo controlled phase.

Assessment of safety and tolerability

Primary end point(s): Total number of confirmed relapses during the placebo-controlled treatment phase.

Secondary Objective: - To assess the effect of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo, on the number of new/enlarging T2 lesions taken at month 6 and 12 (end of placebo-controlled phase).
- To assess the effect of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo, on the cumulative number of enhancing lesions on T1-weighted images taken at months 6 and 12 (end of placebo-controlled phase).
- To assess the effect of Glatiramer Acetate (GA) injection 40 mg administered three times a week compared to placebo on the development of brain atrophy as defined by the percent brain volume change from baseline to the end of the placebo-controlled phase.

Timepoint(s) of evaluation of this end point: at 1, 3, 6, 9, 12 months

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: at 1, 3, 6, 9, 12 months

Secondary end point(s): 1. The cumulative number of new/enlarging T2 lesions taken at month 6 and month 12 (end of PC phase).
2. The cumulative number of enhancing lesions on T1-weighted images taken at months 6 and 12 (end of PC phase).
3. Brain atrophy as defined by the percent brain volume change from baseline to month 12 (end of PC phase).

Secondary ID(s)

MS-GA-301

Source(s) of Monetary Support

Teva Pharmaceutical Industries, Ltd.