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Intrathecal Rituximab in Progressive Multiple Sclerosis (EFFRITE)

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ClinicalTrials.gov Identifier: NCT02545959
Recruitment Status : Completed
First Posted : September 10, 2015
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
University Hospital, Bordeaux
Information provided by (Responsible Party):
Dr Mickaël BONNAN, Centre Hospitalier de PAU

Brief Summary:
The goal of investigators is to study the kinetics of action of a single dose of intrathecally-infused rituximab upon cerebro-spinal fluid (CSF) biological targets in progressive MS patients. Various markers of central nervous system inflammation (osteopontin, Tumor Necrosis Factor α, IgG secretion) and neurodegeneration (neurofilament) are studied at multiple time-points, assuming that a definitive action upon CSF biological targets would be strongly predictive of a delayed clinical action.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Chronic Progressive Nervous System Diseases Drug: Rituximab IT Drug: methylprednisolone IV Drug: Rituximab IV Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intrathecal Rituximab in Progressive Multiple Sclerosis
Actual Study Start Date : November 30, 2015
Actual Primary Completion Date : February 22, 2019
Actual Study Completion Date : September 2, 2019

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Arm Intervention/treatment
Active Comparator: Control group
receive a single pulse of methylprednisolone IV (120mg)
Drug: methylprednisolone IV
blood infusion of methylprednisolone IV (120mg)
Other Name: Solumedrol

Experimental: Rituximab IT group
receive a single intrathecal infusion of rituximab (with IV methylprednisolone 120mg to avoid side effect)
Drug: Rituximab IT
CSF injection of intrathecal rituximab (20mg)
Other Name: intrathecal rituximab (Mabthera)

Drug: methylprednisolone IV
blood infusion of methylprednisolone IV (120mg)
Other Name: Solumedrol

Experimental: Rituximab IT + IV group
receive Rituximab IT as previous and Rituximab IV (375mg/m2) the same day
Drug: Rituximab IT
CSF injection of intrathecal rituximab (20mg)
Other Name: intrathecal rituximab (Mabthera)

Drug: methylprednisolone IV
blood infusion of methylprednisolone IV (120mg)
Other Name: Solumedrol

Drug: Rituximab IV
Blood infusion of rituximab (375mg/m2)
Other Name: Mabthera




Primary Outcome Measures :
  1. Change in osteopontin level in CSF [ Time Frame: at day 4, day 21, day 180 ]

Secondary Outcome Measures :
  1. Change in Tumor Necrosis Factor alpha level in CSF [ Time Frame: day 4, day 21, day 180 ]
  2. Change in IgG synthesis in CSF [ Time Frame: day 4, day 21, day 180 ]
  3. Change in neurofilament level in CSF [ Time Frame: day 4, day 21, day 180 ]

Other Outcome Measures:
  1. Change in clinical parameters [ Time Frame: day 4, day 21, day 180, day 365 ]
    Subjective appreciation and multiple clinical scales (walking time, nine hole peg test, EDSS, SDMT, Fatigue Intensity Scale)

  2. Brain volume atrophy [ Time Frame: day 180, day 365 ]
    Percent change in total brain volume (SIENA)



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02545959


Locations
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France
Centre hospitalier F. Mitterrand (CH Pau)
Pau, France, 64000
Sponsors and Collaborators
Centre Hospitalier de PAU
University Hospital, Bordeaux
Investigators
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Principal Investigator: Mickael Bonnan, MD CH Pau
Publications:
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Responsible Party: Dr Mickaël BONNAN, MD, Centre Hospitalier de PAU
ClinicalTrials.gov Identifier: NCT02545959    
Other Study ID Numbers: CHPAU2014/01
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: April 2019
Keywords provided by Dr Mickaël BONNAN, Centre Hospitalier de PAU:
Intrathecal Rituximab
intrathecal chemotherapy
cerebrospinal fluid
lumbar puncture
Physiological Effects of Drugs
Rituximab
Additional relevant MeSH terms:
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Multiple Sclerosis
Nervous System Diseases
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Rituximab
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones