To describe the efficacy and safety of a maintenance versus induction anti-CD20 treatment strategy in pwMS.
ID
Source
Brief title
Condition
- Demyelinating disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the proportion of pwMS with new and/or enhancing T2
lesions on brain MRI.
Secondary outcome
The secondary endpoints are the proportion of pwMS with symptomatic infections
requiring hospital admission, relapses, confirmed disability progression,
NEDA-3, timed 25-foot walk test, nine hole peg test, single digit modality
test, serum neurofilament level evolution, SARS-CoV-2 antibodies, lymphocyte
repopulation and immunoglobulin level evolution. We will also record the
reasons to prioritize induction vs. continuation of maintenance therapy with
anti-CD20.
Background summary
Anti-CD20 monoclonal antibodies (mAb) target B cells and are an established
second-line therapy in multiple sclerosis (MS). This drug is currently used as
a maintenance therapy, and repeated every 6 months which might result into an
unreasonable disadvantage for certain people with MS (pwMS). First, there is
emerging evidence that anti-CD20 can be used as an induction therapy (i.e.
stopping anti-CD20 infusions after a limited number of infusion cycli) with
preserved long-term efficacy. Second, chronic B cell depletion leads to low IgG
levels which increases susceptibility to infections. Third, anti-CD20-treated
pwMS do not develop an adequate IgG antibody response to vaccines. Fourth,
maintenance therapy with anti-CD20 comes at a considerable cost for the Dutch
health care system. Based on these evolving insights, the physicians at ErasMS
will discuss risks versus benefits of a maintenance and induction strategy in
all pwMS on anti-CD20 who received at least 4 treatment cycles.
Study objective
To describe the efficacy and safety of a maintenance versus induction anti-CD20
treatment strategy in pwMS.
Study design
Prospective, observational study. All pwMS who have received at least 4 cycli
of anti-CD20 treatment and do not show clinical/radiological evidence of
disease activity will be informed about the altered balance between risks
versus benefits when continuing their treatment. Subsequently, we will discuss
the following three treatment strategies: 1) continuing anti-CD20 infusions, 2)
de-escalating anti-CD20 to a first-line treatment or 3) stopping anti-CD20.
Study burden and risks
For all treated pwMS (anti-CD20 or first line treatment), lab tests,
physical/technical examinations and site visits will be requested based on
clinical grounds. For untreated pwMS who participate in this study, there will
be six-monthly blood monitoring and clinic visit whereas outside of the study
context a once yearly frequency for these measurements might be more common.
Doctor Molewaterplein 40 40
Rotterdam 3015GD
NL
Doctor Molewaterplein 40 40
Rotterdam 3015GD
NL
Listed location countries
Age
Inclusion criteria
1. Age * 18 years
2. Diagnosis of MS according to any version of the McDonald criteria
3. Being treated with anti-CD20 mAb in the context of MS
4. Having received at least 4 cycles with anti-CD20 mAb
5. No signs of clinical or radiological disease activity in the preceding 1
year
Exclusion criteria
1. Inability to comply with yearly MRI and 6-monthly clinical monitoring
2. Inability to make an informed treatment decision because of language
barriers
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80481.078.22 |