We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT01719159
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : November 22, 2016
Sponsor:
Collaborator:
Västerbotten County Council, Sweden
Information provided by (Responsible Party):
Anders Svenningsson, Umeå University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Progressive Multiple Sclerosis Drug: Rituximab Phase 2

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
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis
Study Start Date : November 2009
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Secondary Outcome Measures :
  1. 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:
  1. 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

  2. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Anders Svenningsson, MD, PhD Umea university
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Anders Svenningsson, MD, PhD, Assoc Prof, Umeå University
ClinicalTrials.gov Identifier: NCT01719159    
Other Study ID Numbers: ITT-PMS
First Posted: November 1, 2012    Key Record Dates
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:
Layout table for MeSH terms
Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
 Autoimmune Diseases
Immune System Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents