E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 |
The primary objective is to compare between treatment groups the cumulative number of new gadolinium enhancing (Gd+) lesions on brain MRI at weeks 24, 32, 40 and 48 in subjects with relapsing remitting MS. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives include additional MRI measurements, analyses of clinical relapses, measures of neurologic disability, immunologic evaluations, and safety. |
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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 |
Immunology Evaluation, 17 July 2006. A subset of approximately 60 subjects will participate in an immunology sub-study. Blood (60 mL) from each of these 60 subjects will be drawn at weeks 0, 12, 24, 36, and 48. Peripheral blood mononuclear cells (PBMC) from each blood draw will be isolated and stored frozen until after the study is compelted. The frozen samples will be processed for the following analyses: 1) Levels of FOXP3+ Regulatory T cells 2) CFSE assay to detect and characterize TCR peptide induced immune cells, focused on specific T cells types. 3) Direct analysis of vaccination effects on levels of disease specific pathogenic T cells. |
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E.3 | Principal inclusion criteria |
1. Subjects between 18 and 50 years of age, inclusive. 2. Definite MS by the revised McDonald criteria (2005) (Appendix A), with a relapsing remitting course. 3. Expanded Disability Status Scale (EDSS) score ≤ 5.5 (Appendix B). 4. Two or more documented clinical relapses of MS in the preceding 24 months OR one documented clinical relapse in the preceding 12 months prior to screening. 5. Laboratory values within the following limits: • Creatinine < 1.5 x high normal • Hemoglobin > 9.5 mg/dL • SGOT/SGPT < 2.5 x high normal • Platelets > 75,000/mm3 6. Must use effective means of contraception. 7. Must give adequate informed consent and abide by the requirements of the protocol.
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E.4 | Principal exclusion criteria |
1. Pregnant or lactating female. 2. Clinical relapse or corticosteroid treatment within 30 days prior to screening. 3. Prior use of TCR peptides, T cell vaccines, natalizumab, cladribine, or mitoxantrone. 4. Use of beta interferon, glatiramer acetate, methotrexate, azothioprine, cyclophosphamide, any immunostimulatory, immunosuppressive or immunomodulatory therapy within 90 days of screening. 5. Receipt of any immunizations within 30 days prior to Week 0. 6. Use of any statin class medications within 30 days prior to screening. 7. Any other investigational drug within 30 days prior to screening or planned use during study. 8. Active malignancy (other than squamous or basal cell skin cancer or cancer in situ of the cervix). 9. Any medical condition, which in the judgment of the investigator would put the subject at unacceptable risk for participation in the study or that would confound the results of the study. 10. Active substance abuse.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is the cumulative number of new Gd+ lesions on brain MRI at Week 24, 32, 40, and 48 for each subject. All MRIs shall be evaluated in a blinded manner by the central MRI reading facility. |
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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 | No |
E.6.11 | Pharmacogenomic | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 25 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |