Switch To RItuXimab in MS extension An extension study of an ongoing clinical trial where people with multiple sclerosis switch therapy from interferon or glatiramere injections to rituximab, a monoclonal antibody that eliminate B lymphocytes

• Register: EUCTR
• Last refreshed on: 25 June 2018
• Main ID: EUCTR2013-002378-26-SE
• Date of registration: 15/08/2013
• Prospective Registration: Yes
• Primary sponsor: Västerbottens Läns Landsting
• Public title: Switch To RItuXimab in MS extension An extension study of an ongoing clinical trial where people with multiple sclerosis switch therapy from interferon or glatiramere injections to rituximab, a monoclonal antibody that eliminate B lymphocytes
• Scientific title: Switch To RItuXimab in MS extension An extension study of STRIX-MS - a phase 2 open label study of Rituximab in MS patients previously treated with self-injectibles using a target based therapy approach - STRIX-MSext
• Date of first enrolment: 13/11/2014
• Target sample size: 74
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-002378-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: yes; Other trial design description: Therapy switch trial, long-term extension; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Sweden

Contacts

• Name: Neurocentrum
• Affiliation: Västerbottens Läns Landsting

• Name: Neurocentrum
• Affiliation: Västerbottens Läns Landsting

Key inclusion & exclusion criteria

Inclusion criteria:
A subject will be eligible for inclusion in this extension study if all of the following criteria apply:

• Have completed the STRIX-MS trial (Eudra-CT 2010-023021-38).
• Willing to comply with study procedures
• In fertile females, willing to comply with effective contraceptive methods. These include birthcontrol pills, surgical sterilization of patient or partner or consistent use of condom by partner. Nonfertile women is defined as more than 5 years since menopaus or, in case of ambiguities, an FSH level above 30 IU/L

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 74
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria applies:

• Pregnant or lactating women
• Documented vulnerability to infections
• Simultaneous treatment with other immunosuppressive drugs
• Documented allergy or intolerance to Rituximab
• Severe psychiatric condition



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

The original trial (EudraCT 2010-023021-38) recruited 74 patients with relapsing-remitting multiple sclerosis in stable condition while treated with first line injectible disease-modifying drugs (DMDs), eg beta-interferons or glatiramere acetate. This extension study involves the same patients, those that consent to participate in this extension trial.
MedDRA version: 16.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Trade Name: Mabthera®
Generic: Rituximab
Product Name: Mabthera
Pharmaceutical Form: Concentrate for solution for infusion

Primary Outcome(s)

Main Objective: To evaluate the feasability and safety of switching from injectible MS treatments to Mabthera in stable relapsing remitting multiple sclerosis (RRMS).
To study the effects on inflammatory parameters on magnetic resonance imaging when switching MS therapy to Mabthera in RRMS
To study the development of neurodegenerative processes after therapy switch to Rituximab using quantitative MRI measurements and analysis of biomarkers for axonal damage in the cerebrospinal fluid (CSF)
To evaluate long-term effects and safety of treatment with Mabthera in MS

Secondary Objective: To make health economic assessments and compare cost – effectiveness between the present first line disease modifying drugs (DMDs) with Rituximab

To compare patient satisfaction and health related quality of life between the present first line DMD:s and Rituximab

Timepoint(s) of evaluation of this end point: The trial will run over a three year period with a possibility to continue the treatment decided on a case by case basis. Final evaluation of the results will be when all study participants have completed the full three year period.

Primary end point(s): The primary endpoint is
The proportion of patients undergoing the predefined study protocols over three years that fulfils the criteria “free from disease activity” defined as:
o Free from clinical relapse
o Free from contrast-enhancing MRI lesions
o No more than one new or enlarged MRI lesion visible on T2-weighted images during the previous 12 month period

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: The secondary endpoints will be finally evaluated also after three years when last subject has had its last visit

Secondary end point(s): The secondary endpoints are:
• The proportion of patients free from all signs of disease activity including, in addi-tion to the primary endpoint, no new T2 lesions during the whole study period and no increase in EDSS.
- The period included in this analysis is from month 0 in the original STRIX-MS study, ie when Rituximab was administered in the first time.
• The degree of brain atrophy development over the course of the whole study peri-od measured as BPF as compared with age-matched healthy controls
• The levels of Neurofilament-light values in CSF analyses, which will be compared with age-matched healthy controls as well as before Rituximab treatment started.
• The proportion of patients undergoing the predefined study protocol that because of disease activity will either change therapy or obtain additional Rituximab infu-sions.
• To document the safety of Rituximab treatment during long-term treatment of RRMS patients with Rituximab using a target based treatment protocol.

Secondary ID(s)

STRIX-MSext001

Source(s) of Monetary Support

Neurocentrum, Västerbottens Läns Landsting