NCT01719159

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2009

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 1, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

6.6 years

First QC Date

October 25, 2012

Last Update Submit

November 18, 2016

Conditions

Progressive Multiple Sclerosis

Keywords

Progressive multiple sclerosisMonoclonal antibodiesMabtheraIntrathecal treatment

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events

    Feasibility of IT administered monoclonal antibodies

    One year after completed treatment

Secondary Outcomes (1)

  • Stabilisation of the neurological deterioration

    At 3,6,9,12 month after completed treatment

Other Outcomes (2)

  • Immunological markers in blood

    At 3,6,9,12 month after treatment

  • Immunological markers in cerebrospinal fluid (CSF)

    At 3, 6, 9 12 month after treatment

Study Arms (1)

Rituximab

EXPERIMENTAL

Rituximab, 25 mg, is administrated intrathecal three times one week apart

Drug: Rituximab

Interventions

RituximabDRUG

25 mg rituximab is injected intrathecally via an Ommaya reservoir once a week for 3 weeks. Patients are then followed for one year.

Also known as: Mabthera
Rituximab

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of neurology, Umeå University Hospital

Umeå, 901 85, Sweden

Location

Dept of neurology, Uppsala University Hospital

Uppsala, SE-751 85, Sweden

Location

Related Publications (2)

  • Bergman J, Burman J, Gilthorpe JD, Zetterberg H, Jiltsova E, Bergenheim T, Svenningsson A. Intrathecal treatment trial of rituximab in progressive MS: An open-label phase 1b study. Neurology. 2018 Nov 13;91(20):e1893-e1901. doi: 10.1212/WNL.0000000000006500. Epub 2018 Oct 10.

    PMID: 30305449DERIVED

  • Bergman J, Dring A, Zetterberg H, Blennow K, Norgren N, Gilthorpe J, Bergenheim T, Svenningsson A. Neurofilament light in CSF and serum is a sensitive marker for axonal white matter injury in MS. Neurol Neuroimmunol Neuroinflamm. 2016 Aug 2;3(5):e271. doi: 10.1212/NXI.0000000000000271. eCollection 2016 Oct.

    PMID: 27536708DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Anders Svenningsson, MD, PhD

    Umea university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD, Assoc Prof

Study Record Dates

First Submitted

October 25, 2012

First Posted

November 1, 2012

Study Start

November 1, 2009

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

November 22, 2016

Record last verified: 2016-11

Locations

SE(2)