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

This study has been completed.
Västerbotten County Council, Sweden
Information provided by (Responsible Party):
Anders Svenningsson, Umeå University Identifier:
First received: October 25, 2012
Last updated: November 18, 2016
Last verified: November 2016
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: 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 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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01719159

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
Principal Investigator: Anders Svenningsson, MD, PhD Umea university
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Anders Svenningsson, MD, PhD, Assoc Prof, Umeå University Identifier: NCT01719159     History of Changes
Other Study ID Numbers: ITT-PMS
Study First Received: October 25, 2012
Last Updated: November 18, 2016
Individual Participant Data  
Plan to Share IPD: Undecided
Plan Description: IPD will be shared upon request from the researcher or scientific journals

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

Additional relevant MeSH terms:
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on March 28, 2017