Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple
Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Rituximab
B-lymphocyte antigen CD20 binding agent
What it measured
Main measures
Number of participants with adverse events
One year after completed treatment
SafetyFeasibility
Other measures (1)
Stabilisation of the neurological deterioration
At 3,6,9,12 month after completed treatment
FatigueQuality of life (reported by participants)
Who could take part
Progressive MS · 18 to 65 · EDSS 0 to 7.0
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Intrathecal treatment trial of rituximab in progressive MS: An open-label phase 1b study.Neurology · 2018
Results
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.
Loading reviews and guidelines…
Related trials
- C-CAR168, an Autologous Anti-CD20/BCMA Chimeric Antigen Receptor T-Cel
Phase 1 / Phase 2 · Not yet recruiting
Still running
- IDP-023 g-NK Cells Plus Ocrelizumab in Patients With Progressive Multi
Phase 1 · Paused
Still running
- The Effect of Rituximab on Cognitive and Hand Functions in Secondary P
Phase 2 · Recruiting
Still running
- Effect of Ocrelizumab on Cortical Lesion Accumulation in Patients With
Completed
No results found
- Effect of Ocrelizumab on Choroid Plexus Changes in Patients With PPMS
Completed
No results found
- A Study To Determine The Effect Of Ocrelizumab On Leptomeningeal Infla
Phase 4 · Withdrawn
Stopped
History
Started
Nov 2009
Main results due
Jun 2016
Finished
Jun 2016