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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02545959 |
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Date of registration:
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07/09/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Intrathecal Rituximab in Progressive Multiple Sclerosis
EFFRITE |
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Scientific title:
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Intrathecal Rituximab in Progressive Multiple Sclerosis |
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Date of first enrolment:
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November 30, 2015 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02545959 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Mickael Bonnan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CH Pau |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age =45 years, male or female ;
- Secondary or primary progressive MS, in progressive phase since >2 years ;
- EDSS =6.0 ;
- Absence of alternative therapy.
Exclusion Criteria:
- Relapsing-remitting phase of MS;
- Contraindication to MRI, lumbar puncture, Trendelenburg position ;
- Active infection or immunosuppressive state or treatment (actual or less than 6
months);
- Earlier treatment with rituximab;
- Dementia or severe psychiatric disorder.
Age minimum:
45 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis, Chronic Progressive
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Nervous System Diseases
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Intervention(s)
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Drug: Rituximab IT
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Drug: methylprednisolone IV
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Drug: Rituximab IV
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Primary Outcome(s)
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Change in osteopontin level in CSF
[Time Frame: at day 4, day 21, day 180]
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Secondary Outcome(s)
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Change in Tumor Necrosis Factor alpha level in CSF
[Time Frame: day 4, day 21, day 180]
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Change in IgG synthesis in CSF
[Time Frame: day 4, day 21, day 180]
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Change in neurofilament level in CSF
[Time Frame: day 4, day 21, day 180]
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Secondary ID(s)
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CHPAU2014/01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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