E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Secondary progressive multiple sclerosis |
|
E.1.1.1 | Medical condition in easily understood language |
Secondary progressive multiple sclerosis |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10063400 |
E.1.2 | Term | Secondary progressive multiple sclerosis |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
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 long-term stabilising effects of on neurological symptoms by regular IT administered monoclonal antibodies in MS. |
|
E.2.2 | Secondary objectives of the trial |
Assess the development of brain atrophy and lesion load on cranial MRI
Assess any changes in the levels of neurodegenerative markers in the CSF
Assess quality of life and fatigue in relation to long-term intrathecal therapy
Long-term safety |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Completed the ITT-MS trial (EudraCT number 2008-002626-11)
•Other therapy not indicated, contraindicated or failed
•Judged as compliant with the protocol
•In fertile females, willing to comply with effective contraceptive methods.
•Signed informed consent |
|
E.4 | Principal exclusion criteria |
•Eligible for any of the conventional MS therapies
•Bleeding diathesis or medication contraindicating lumbar puncture
•Cognitive defect making informed consent unreliable
•Severe, uncontrolled heart disease
•Pregnant or lactating women
•Patients having contraindication for or otherwise not compliant with MRI investigations
•Documented vulnerability to infections
•Simultaneous treatment with other immunosuppressive drugs
•Documented allergy or intolerance to Rituximab
•Severe psychiatric condition
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The time to progression ≥ 1,0 step on the EDSS scale |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
A main assessment is performed at 24 month. If no safety issues have emerged, stable patients will be offered continued treatment with this schedule in a case-by-case agreement manner |
|
E.5.2 | Secondary end point(s) |
•Tests of walking ability and hand function
•Questionaires regarding MS quality of life, symptom inventory and fatigue
•Neurofilament levels in the CSF
•Immunological markers in blood and CSF such as absolute numbers of major lym-phocyte subset as well as regulatory cell subset
•Safety assessment
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
A main assessment is performed at 24 month. If no safety issues have emerged, stable patients will be offered continued treatment with this schedule in a case-by-case agreement manner |
|
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 | Yes |
E.6.13.1 | Other scope of the trial description |
|
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | 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 | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
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
|
When the last patient has been followed for two years |
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |