E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
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 |
The aim of this study is to investigate the safety of intrathecal administered Rituximab to patients with secondary progressive multiple sclerosis, based upon analysis of the intrathecal and periferal immune response. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objective is to investigate effects of intrathecal administered rituximab on clinical performance, cognition and MRI parameters. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Clinical definate multiple sclerosis
Secondary progressive multiple sclerosis defines as no relaps within 1 year, and sustained progression more than 3 month
Disease duration >15 years
EDSS score 3-7 (both included)
No contrast enhancement on MRI
Presence of oligoclonal bands and increased intrathechal IgG index |
|
E.4 | Principal exclusion criteria |
Pregnancy and lactation
Positive anti-JC virus antibody
Treatment with Natalizumab within 6 month
Treatment with interferon-beta or glatiramer acetate within 3 month
Prior treatment with immunosupressant
Decreased leucocyte or platelet count
Decreased liver or kidneyfunction
B-cell deficiency (low IgA, IgG or IgM)
Implanted metal or devices that contraindicates MRI |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in spinal fluid immune respons after 1 and 3 month |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Safety (Adverse events)
Changes in the following:
1) Spinal fluid immune respons 6 month after first and second treatment
2) Systemic immune respons 1,3,6,9,12,15,18,21 and 24 month after treatment
3) MRI 2 years after treatment
4) Cognition 2 years after treatment
5) EDSS and MSIS 12 and 24 months after treatment |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 |
To investigate in a pilot study whether safety and secondary end-points will substantiate a later large clinical trial designed to evaluate clinical end points |
|
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |