E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | Relapsing-remitting Multiple Sclerosis (RR MS) | |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 | E.1.2 | Level | PT | E.1.2 | Classification code | 10028245 | |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial | 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. | |
E.2.2 | Secondary objectives of the trial | 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). | |
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives | 1. Frequent MRI: MRI will be performed at Months 0 (baseline), 1, 2, 3, 6, 9 and 12 (termination/early discontinuation). 2. MT will be assessed at Months 0 (baseline) and 12 (termination/early discontinuation). 3. MRS will be assessed at Months 0 (baseline) and 12 (termination/early discontinuation). 4. Anti GA antibodies: serum samples to detect anti GA specific antibodies will be collected at Months 0 (baseline), 1, 3, 6, 9 and 12 (termination/early discontinuation). 5. Pharmacogenetic parameters: blood for analysis of genetic markers will be sampled at randomization in a subset of countries and sites. The assessment of possible relations between genes related to and response to GA will be performed. Evaluations will be based on results from the subjects as a group. Individual subjects will not be identified. Data will be kept confidential and stored separately. Subjects will have to give separate consent to the sampling and storage. This analysis will be performed in the pooled population of the programme. | |
E.3 | Principal 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. | |
E.4 | Principal 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. | |
E.5 End points |
E.5.1 | Primary end point(s) | Total number of confirmed relapses. | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 | The trial involves single site in the Member State concerned | No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned | |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial | Last visit of last subject undergoing the trial. | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 1 |