A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2006-002037-20-BE
• Date of registration: 19/07/2006
• Prospective Registration: Yes
• Primary sponsor: Teva Pharmaceutical Industries, Ltd.
• Public title: A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE
• Scientific title: A multi-national, multi-centre, randomized, parallel-group, double-blind study to compare the efficacy, tolerability and safety of Glatiramer Acetate Injection 40 mg/ml to that of Glatiramer Acetate Injection 20 mg/ml administered once daily by subcutaneous injection in subjects with relapsing remitting (RR) Multiple Sclerosis (MS) - FORTE
• Date of first enrolment: 27/09/2006
• Target sample size: 980
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002037-20
• 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: yes Placebo: no Other: no

Countries of recruitment

Belgium, Czech Republic, Estonia, Germany, Hungary, Italy, Latvia, Lithuania, Spain, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Subjects must have a confirmed and documented MS diganosis as defined by the Revised McDonald criteria [Ann Neurol 2005: 58:840-846].
2. Subjects must be of RR MS type [Neurol 1996;46:907-911].
3. Subjects must be relapse free and in stable neurological condition at least 30 days prior to screening.
4. Subjects must have experienced one of the following:
+ At least one documented relapse in the 12 months prior to screening.
+ At least two documented relapses in the 24 months prior to screening.
+ 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 have a disease duration of at least 6 months prior to screening.
6. Subjects must be between 18 and 55 years of age (inclusive).
7. Subjects must be ambulatory with converted Kurtzke EDSS score of 0-5.
8. Women of child-bearing potential must practice an acceptable method of birth control.
9. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
10. Subjects must be able to sign and date a written informed consent prior to entering 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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Any treatment with corticosteroids (IV, IM and/or PO) within 30 days prior to screening.
2. An onset of relapse or any treatment with corticosteroids (IV, IM and/or PO) between Month -1 (screening) and Month 0 (baseline).
3. Chronic (more than 30 consecutive days) corticosteroid treatment (IV, IM; and/or PO) within 6 months prior to screening visit.
4. Use of cladribine within 2 years prior to screening.
5. Previous total body or lymphoid irradiation.
6. Use of immunosuppressive agents (including mitoxantrone) within 6 months prior to screening visit.
7. Previous treatment with immunomodulators (including IFN beta 1a and 1b, and IV immunoglobulin) within 2 months prior to screening.
8. Previous use of GA.
9. Previous use of natalizumab.
10. Previous stem cell treatment.
10. Use of experimental drugs (including TV-5010, laquinimod and oral GA) within 6 months prior to screening.
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 judgement.
13. Subject's inability to complete the study or if the subject is considered by the investigator for any reason to be an unsuitable canditate for this study.
14. A known hypersensitivity to mannitol.
15. A known hypersensitivity to gadolinium (Gd).
16. Inability to successfully undergo MRI scanning.


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

Health Condition(s) or Problem(s) studied

Relapsing-remitting Multiple Sclerosis (RR MS)
MedDRA version: 8.1 Level: PT Classification code 10028245

Intervention(s)

Product Name: 40 mg glatiramer acetate
Product Code: 40 mg GA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: n.a.
CAS Number: 147245-92-9
Current Sponsor code: 40 mg GA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 40-

Product Name: Copaxone 20 mg/ml Solution for Injection, pre-filled syringe
Product Code: 20 mg GA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: n.a.
CAS Number: 147245-92-9
Current Sponsor code: 20 mg GA
Other descriptive name: Copaxone
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Main Objective: To compare the efficacy of daily subcutaneous injections of 40 mg glatiramer acetate (GA) to that of 20 mg GA (Copaxone) in RR MS patients as determined by the confirmed relapse rates.

Secondary Objective: Time to first confirmed relapse.
Proportion (%) of patients experiencing (a) relapse(s).
Number of new T2 lesions at termination compared to baseline scan.
Total number of T1-Gd enhancing lesions at months 3, 6, 9 and 12 (Frequent MRI Cohort).
Total number of T1-Gd enhancing lesions at months 1, 2 and 3 (Frequent MRI Cohort).

Primary end point(s): Total number of confirmed relapses.

Secondary ID(s)

2006-002037-20-HU

GA/9016

N.A.