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| Name | Class |
|---|---|
| Prothya Biosolutions | INDUSTRY |
| Erasmus Medical Center | OTHER |
| St. Antonius Hospital | OTHER |
| OLVG |
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A prospective clinical trial with the aim of maintaining drug efficacy of natalizumab while extending dose intervals guided by drug concentrations in patients with relapsing remitting multiple sclerosis.
Our main objective is to prove that extending dose intervals guided by natalizumab serum concentrations, will not result in radiological or clinical disease activity in completely stable RRMS patients treated with natalizumab. Adult patients with RRMS with no evident disease activity during the last 12 months of natalizumab infusions with a minimum treatment of 12 months wil be included. Before subsequent natalizumab infusions, serum concentrations will be evaluated. If the concentration exceeds 15μg/ml the dose interval will be extended with a week to a maximum of eight weeks. Patients will get regular brain MRI scans and clinical follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients in this study | Other | Patients treated with natalizumab with a minimum of 1 year, without signs of disease activity (relapses, new T2 lesions on MRI) for a minimum of 1 year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natalizumab | Drug | Extending dose intervals of natalizumab from 4 weeks to maximum of 8 weeks based on trough natalizumab concentrations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gadolinium enhancing T1 lesions on brain MRI | Occurrence and number of gadolinium enhancing T1 lesions of brain MRI | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| New T2 lesions on brain MRI | Occurrence and number of new T2 lesions on brain MRI | 12 months |
| Relapses | scoring MS exacerbations | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joep Killestein, Dr. | Amsterdam UMC, location VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLVG | Amsterdam | Netherlands | ||||
| VU medical center |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000069442 | Natalizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| NETWORK |
| Rijnstate Hospital | OTHER |
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| EDSS | Expanded Disability Status Scale: clinical scoring of disability in MS patients | 12 months |
| MSFC | Multiple Status Functional Composite: clinical scoring of disability in MS patients | baseline and 12 months |
| patient perspective measured with the SF-36 | questionnaire: Short Form-36 | baseline and 12 months |
| patient perspective measured with the MSIS-29 | questionnaire: Multiple Sclerosis Impact Scale-29 | baseline and 12 months |
| Amsterdam |
| Netherlands |
| Rijnstate Hospital | Arnhem | Netherlands |
| Erasmus medical center | Rotterdam | Netherlands |
| St. Antonius Hospital | Utrecht | Netherlands |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |