Health TrialsbyHealthPanel

Switch to Ofatumumab and Level of Immunoglobulins

ConditionMultiple Sclerosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity Hospital, Lille

About this trial

This real-life study aims to describe IgG levels after switching from ocrelizumab 600 mg IV every 6 to 8 months in Patients with Multiple Sclerosis (PwMS) to ofatumumab 20 mg SC every month and showing a decreasing level of IgG during treatment by ocrelizumab in real life practice in France over 24 months of follow-up.

The primary objective is therefore to determine if the downward trend of IgG observed during ocrelizumab treatment is modified after a switch to ofatumumab, in PwMS treated during at least 18 months of ocrelizumab in real life practice, over 24 months of follow-up.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients (≥ 18 years old) who had been treated with ocrelizumab for a relapsing form of Multiple Sclerosis according to the ocrelizumab marketing authorization (MA) treatment regimen for at least 18 months.

Patients with a decrease of IgG at a minimum of two consecutive dosages (around six months apart) during ocrelizumab treatment*.

Patients already switched or switching from ocrelizumab to ofatumumab treatment (decision independent from the study*).

Patients agreeing to participate to the study.

Disqualifiers

Patients with ocrelizumab dose spacing > 8 months in the last 18 months before switch

Patient who underwent an immunoglobulin supplementation therapy within 18 months before the switch

Ongoing or planned pregnancy

Trial population

The study population will be adult patients with MS (women and men) who initiate treatment with ofatumumab after a treatment with ocrelizumab

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • ofatumumab

    Drug

    There is no treatment allocation. Participants with MS that initiated treatment with ofatumumab (Kesimpta ®) as per neurologist practice and regardless of the study protocol.

Treatment groups

115 Participants
are divided into 1 treatment group
Group A: Ofatumumab1 intervention

Trial outcomes

Primary outcomes

1

Slope of serum immunoglobulin G (IgG) levels during ocrelizumab treatment period (minimum 18 months)

Time frame
42 months
2

Slope of serum immunoglobulin G (IgG) levels during ofatumumab treatment period (24 months)

Time frame
42 months

Secondary outcomes

1

Age at baseline (years)

Time frame
Baseline
2

Number and percentage of patients with stable serum IgG levels

Time frame
24 months
3

Number of severe infections occurring during ocrelizumab treatment period prior to switch to ofatumumab

Time frame
18 months
4

Slope of serum immunoglobulin M (IgM) levels during ocrelizumab treatment period (minimum 18 months)

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Lille

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: