E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsing Forms of Multiple Sclerosis |
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E.1.1.1 | Medical condition in easily understood language |
Relapsing Forms of Multiple Sclerosis |
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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 | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10048393 |
E.1.2 | Term | Multiple sclerosis relapse |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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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 |
The primary objective for this study is long-term safety (incidence and pattern of SAEs) in patients receiving natalizumab. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives include long-term efficacy of natalizumab in delaying the progression of disability, reducing the frequency of relapses, MRI activity (for safety reasons) and explore quality of life and cognitive function in patients on treatment with natalizumab for more than 8 years. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Have the ability to understand the purpose and risks of the study and provide signed and dated informed consent and any authorizations required by local law in accordance with national and local subject privacy regulations.
2. Has participated in the STRATA Study, have stable disease and do not meet reimbursement criteria for natalizumab (Tysabri®) in Belgium, upon termination of the STRATA Study.
3. Are ≥18 years old.
4. Subjects of child bearing potential must practice effective contraception during the study and be able to continue contraception for 3 months after their last infusion.
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E.4 | Principal exclusion criteria |
1. Patients participating in STRATA who were in line with current Belgian reimbursement criteria when they started in one of the feeder studies (Affirm or Sentinel).
2. Subjects with any significant change in clinical status, that in the opinion of the Investigator, would make them unsuitable to participate in this study. The investigator must review the subject’s medical fitness for participation and consider any diseases that would preclude treatment.
3. Subjects that are unwilling or unable to comply with study requirements, or are deemed unsuitable for study participation as determined by the Investigator.
4. Female Subjects who are considering becoming pregnant while in the study.
5. Female Subjects of childbearing potential and are not using the appropriate contraception as determined by the Investigator.
6. Female subjects who are currently pregnant or breastfeeding.
7. Any prescheduled elective procedure during the study period that, in the opinion of the Investigator, would interfere with study parameters.
8. Any other condition, clinical finding, or reason that, in the opinion of the Investigator, is determined to be unsuitable for enrollment into this study
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of the open label study is the incidence of AEs and SAEs. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
When there's an incidence of AEs and SAEs |
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E.5.2 | Secondary end point(s) |
• Disability progression as determined by Expanded Disability Status Scale
(EDSS) (based on neurological examination, “physical EDSS”) every six
months
• MS disease activity as determined by the occurrence of clinical relapses
(distribution of the total number of relapses over 2 years)
• JCV status (anti-JCV antibody positive or negative according to the
STRATIFY JCV® Test, Unilabs, Denmark)
• Frequent MRI monitoring according to guidelines Belgian Study Group for
MS
• Quality of life measurement by EQ-5D every six months
• Cognitive evaluation by Symbol Digit Modalities Test (SDMT) every six
months
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
If patient doesn't want to participate anymore. |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | 4 |
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
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The study will consist of a screening/enrollment Visit, baseline visit and a 24 months treatment period. |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |