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

This study is currently recruiting participants.
Verified October 2012 by Umeå University
Sponsor:
Collaborator:
Västerbotten County Council, Sweden
Information provided by (Responsible Party):
Anders Svenningsson, Umeå University
ClinicalTrials.gov Identifier:
NCT01719159
First received: October 25, 2012
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis

Resource links provided by NLM:

Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: One year after completed treatment ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    I.e. absolute numbers of major lymphocyte subset as well as regulatory cell subset


Estimated Enrollment: 30
Study Start Date: November 2009
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (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
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719159

Contacts
Contact: Anders Svenningsson, MD, PhD +46 90 785 ext 1933 anders.svenningsson@neuro.umu.se

Locations
Sweden
Department of neurology, Umeå University Hospital Recruiting
Umeå, Sweden, 901 85
Contact: Anders Svenningsson, MD, PhD     +46 90785 ext 1933     anders.svenningsson@neuro.umu.se    
Principal Investigator: Anders Svenningsson, MD, PhD            
Dept of neurology, Uppsala University Hospital Not yet recruiting
Uppsala, Sweden, SE-751 85
Contact: Joachim Burman, MD         joachim.burman@neuro.uu.se    
Principal Investigator: Joachim Burman, MD            
Sponsors and Collaborators
Anders Svenningsson
Västerbotten County Council, Sweden
Investigators
Principal Investigator: Anders Svenningsson, MD, PhD Umea university
  More Information

No publications provided

Responsible Party: Anders Svenningsson, MD, PhD, Assoc Prof, Umeå University
ClinicalTrials.gov Identifier: NCT01719159     History of Changes
Other Study ID Numbers: ITT-PMS
Study First Received: October 25, 2012
Last Updated: October 29, 2012
Health Authority: Sweden: Medical Products Agency

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

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

ClinicalTrials.gov processed this record on May 23, 2013