E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subject with Relapse-Remitting Multiple Sclerosis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10063399 |
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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 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 study design. |
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E.2.2 | Secondary objectives of the trial |
The number of new T2 lesions at month 12 (end of PC phase) as compared to baseline scan. The cumulative number of enhancing lesions on T1-weighted images taken at months 6 and 12 (end of PC phase). Brain atrophy as defined by the percent brain volume change from baseline to month 12 (end of PC phase). |
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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 |
FARMACOECONOMIA: Versione:finale Data:2009/12/17 Titolo:incluso nel titolo del protocollo principale Obiettivi:Valutazione dell�effetto delle condizioni di salute generale e severita` dei sintomi sul lavoro, utilizzando il questionario Produttivita` del lavoro e indebolimento dell�attivita` � stato generale di salute (WPAI-GH)
FARMACOGENETICA: Versione:finale Data:2009/12/17 Titolo:studio ancillare di Farmacogenetica (PGx) Obiettivi:Valutazione di possibili associazioni tra polimorfismi genetici e la risposta a GA. La valutazione sara` basata su risultati ottenuti da soggetti come gruppo fenotipico.
ALTRI SOTTOSTUDI: Presenza di anticorpi anti-GA nel siero
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E.3 | Principal 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 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 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. |
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E.4 | Principal 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 (including IFNβ 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The total number of confirmed relapses during the 12 month PC phase. |
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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 | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
presenza di anticorpi anti-GA |
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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) | No |
E.8.2.2 | Placebo | Yes |
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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 110 |
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 |
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E.8.7 | Trial has a data monitoring committee | Yes |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |