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

October 25, 2012
October 29, 2012
November 2009
November 2014   (final data collection date for primary outcome measure)
Number of participants with adverse events [ Time Frame: One year after completed treatment ] [ Designated as safety issue: Yes ]
Feasibility of IT administered monoclonal antibodies
Same as current
Complete list of historical versions of study NCT01719159 on ClinicalTrials.gov Archive Site
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.
Same as current
  • 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
Same as current
 
Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis
Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis

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.

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

Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Progressive Multiple Sclerosis
Drug: Rituximab
Other Name: Mabthera
Experimental: Rituximab
Rituximab, 25 mg, is administrated intrathecal three times one week apart
Intervention: Drug: Rituximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
November 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Anders Svenningsson, MD, PhD +46 90 785 ext 1933 anders.svenningsson@neuro.umu.se
Sweden
 
NCT01719159
ITT-PMS
No
Anders Svenningsson, Umeå University
Anders Svenningsson
Västerbotten County Council, Sweden
Principal Investigator: Anders Svenningsson, MD, PhD Umea university
Umeå University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP