An extension trial of intrathecal therapy with monoclonal antibodies in progressive multiple sclerosis

ITT-PMS Extension An extension study of intrathecal therapy with monoclonal antibodies in progressive multiple sclerosis - ITT-PMS Ext

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000721-53-SE

Enrollment

Registered

2012-10-16

Start date

2012-12-07

Completion date

Unknown

Last updated

2018-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary progressive multiple sclerosis MedDRA version: 14.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: Mabthera Product Name: Mabthera Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg milligram(s) Concen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Completed the ITT-MS trial (EudraCT number 2008-002626-11) •Other therapy not indicated, contraindicated or failed •Judged as compliant with the protocol •In fertile females, willing to comply with effective contraceptive methods. •Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: •Eligible for any of the conventional MS therapies •Bleeding diathesis or medication contraindicating lumbar puncture •Cognitive defect making informed consent unreliable •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

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess long-term stabilising effects of on neurological symptoms by regular IT administered monoclonal antibodies in MS.;Secondary Objective: Assess the development of brain atrophy and lesion load on cranial MRI Assess any changes in the levels of neurodegenerative markers in the CSF Assess quality of life and fatigue in relation to long-term intrathecal therapy Long-term safety;Primary end point(s): The time to progression = 1,0 step on the EDSS scale ;Timepoint(s) of evaluation of this end point: A main assessment is performed at 24 month. If no safety issues have emerged, stable patients will be offered continued treatment with this schedule in a case-by-case agreement manner	—

Measure

Time frame

Main Objective: To assess long-term stabilising effects of on neurological symptoms by regular IT administered monoclonal antibodies in MS.;Secondary Objective: Assess the development of brain atrophy and lesion load on cranial MRI Assess any changes in the levels of neurodegenerative markers in the CSF Assess quality of life and fatigue in relation to long-term intrathecal therapy Long-term safety;Primary end point(s): The time to progression = 1,0 step on the EDSS scale ;Timepoint(s) of evaluation of this end point: A main assessment is performed at 24 month. If no safety issues have emerged, stable patients will be offered continued treatment with this schedule in a case-by-case agreement manner

—

Secondary

Measure	Time frame
Secondary end point(s): •Tests of walking ability and hand function •Questionaires regarding MS quality of life, symptom inventory and fatigue •Neurofilament levels in the CSF •Immunological markers in blood and CSF such as absolute numbers of major lym-phocyte subset as well as regulatory cell subset •Safety assessment ;Timepoint(s) of evaluation of this end point: A main assessment is performed at 24 month. If no safety issues have emerged, stable patients will be offered continued treatment with this schedule in a case-by-case agreement manner	—

Measure

Time frame

Secondary end point(s): •Tests of walking ability and hand function •Questionaires regarding MS quality of life, symptom inventory and fatigue •Neurofilament levels in the CSF •Immunological markers in blood and CSF such as absolute numbers of major lym-phocyte subset as well as regulatory cell subset •Safety assessment ;Timepoint(s) of evaluation of this end point: A main assessment is performed at 24 month. If no safety issues have emerged, stable patients will be offered continued treatment with this schedule in a case-by-case agreement manner

—

Countries

Sweden

Contacts

Public ContactUniversity Hospital Department

Dept of Neurology, Umeå University Hospital, Umeå, Sweden

anders.svenningsson@neuro.umu.se46907851933

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026