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Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis (ITT-PMS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01719159
First Posted: November 1, 2012
Last Update Posted: November 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Västerbotten County Council, Sweden
Information provided by (Responsible Party):
Anders Svenningsson, Umeå University
  Purpose
This is a is a small scale open phase two interventional study to assess long-term stabilising effects of on neurological symptoms by regular intrathecal administered monoclonal antibodies in progressive multiple sclerosis.

Condition Intervention Phase
Progressive Multiple Sclerosis Drug: Rituximab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Anders Svenningsson, Umeå University:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: One year after completed treatment ]
    Feasibility of IT administered monoclonal antibodies


Secondary Outcome Measures:
  • Stabilisation of the neurological deterioration [ Time Frame: At 3,6,9,12 month after completed treatment ]
    Questionaires regarding MS quality of life, symptom inventory and fatigue will be used.


Other Outcome Measures:
  • Immunological markers in blood [ Time Frame: At 3,6,9,12 month after treatment ]
    I.e. absolute numbers of major lymphocyte subset as well as regulatory cell subset

  • Immunological markers in cerebrospinal fluid (CSF) [ Time Frame: At 3, 6, 9 12 month after treatment ]
    I.e. absolute numbers of major lymphocyte subset as well as regulatory cell subset


Enrollment: 23
Study Start Date: November 2009
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab
Rituximab, 25 mg, is administrated intrathecal three times one week apart
Drug: Rituximab
25 mg rituximab is injected intrathecally via an Ommaya reservoir once a week for 3 weeks. Patients are then followed for one year.
Other Name: Mabthera

Detailed Description:
There is presently no efficient therapy available in progressive MS, especially if there is no clear evidence of active inflammatory lesions or exacerbations as part of the disease. There are, however, evidence that some treatment protocols using cytotoxic drugs may to some extent slow down the progressive course. One specific feature of long-standing MS is that inflammatory cells accumulate in the central nervous system(CNS) compartment in the subarachnoid and perivascular spaces and may therefore be hard to reach via standard drug delivery through systemic administration. Administration of substances via the Intrathecal (IT) route, however, have shown to efficiently distribute in the subarachnoid spaces and may therefore be an attractive route of drug delivery
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between the age of 18 and 65 years of age (nonfertile women or fertile women with effective contraceptive methods)
  • Progressive MS since at least three years
  • Some kind of documented progression of neurological symptoms during the previous two years.
  • Expanded Disability Status Scale (EDSS) 4,0 - 7.0 (inclusive) (basically spared arm functions)
  • Conventional therapy not indicated, contraindicated or failed
  • Judged as compliant with the protocol

Exclusion Criteria:

  • Eligible for any of the conventional MS therapies
  • Relapsing remitting multiple sclerosis (RRMS)
  • Bleeding diathesis or medication contraindicating neurosurgical procedures or lumbar puncture
  • Cognitive defect making informed consent unreliable
  • Any medical condition contraindicating minor surgical procedures, as judged by anaesthesiologist
  • Severe, uncontrolled heart disease
  • Pregnant or lactating women
  • Patients having contraindication for or otherwise not compliant with MRI investigations
  • Documented vulnerability to infections
  • Simultaneous treatment with other immunosuppressive drugs
  • Documented allergy or intolerance to Rituximab
  • Severe psychiatric condition
  Contacts and Locations
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): NCT01719159


Locations
Sweden
Department of neurology, Umeå University Hospital
Umeå, Sweden, 901 85
Dept of neurology, Uppsala University Hospital
Uppsala, Sweden, SE-751 85
Sponsors and Collaborators
Anders Svenningsson
Västerbotten County Council, Sweden
Investigators
Principal Investigator: Anders Svenningsson, MD, PhD Umea university
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anders Svenningsson, MD, PhD, Assoc Prof, Umeå University
ClinicalTrials.gov Identifier: NCT01719159     History of Changes
Other Study ID Numbers: ITT-PMS
First Submitted: October 25, 2012
First Posted: November 1, 2012
Last Update Posted: November 22, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: IPD will be shared upon request from the researcher or scientific journals

Keywords provided by Anders Svenningsson, Umeå University:
Progressive multiple sclerosis
Monoclonal antibodies
Mabthera
Intrathecal treatment

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents


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