Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis (ITT-PMS)
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ClinicalTrials.gov Identifier: NCT01719159 |
Recruitment Status :
Completed
First Posted : November 1, 2012
Last Update Posted : November 22, 2016
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Condition or disease | Intervention/treatment | Phase |
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Progressive Multiple Sclerosis | Drug: Rituximab | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Rituximab
Rituximab, 25 mg, is administrated intrathecal three times one week apart
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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 |
- Number of participants with adverse events [ Time Frame: One year after completed treatment ]Feasibility of IT administered monoclonal antibodies
- 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.
- 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

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older 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

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
Sweden | |
Department of neurology, Umeå University Hospital | |
Umeå, Sweden, 901 85 | |
Dept of neurology, Uppsala University Hospital | |
Uppsala, Sweden, SE-751 85 |
Principal Investigator: | Anders Svenningsson, MD, PhD | Umea university |
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 |
Progressive multiple sclerosis Monoclonal antibodies Mabthera Intrathecal treatment |
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 |