Circulating B-cell, Drug and Anti-drug Antibodies Monitoring in Patients Treated With Rituximab for Autoimmune Disorders

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nice

About this trial

The MONIRITUX study aimed to evaluate whether monitoring (i) circulating B-cell reconstitution or (ii) serum rituximab levels could help identify relapse of autoimmune diseases in patients treated with rituximab. Retrospective data suggest that B-cell reconstitution or the appearance of anti-drug antibodies are associated with rituximab's failure to prevent relapses (i.e. rheumatoid arthritis, systemic lupus erythematosus, autoimmune cytopenia...). According to the routine care provided by our institution, patients undergoing rituximab therapy are monitored every three months during the first year after treatment induction and every six months thereafter. At each clinical visit, a blood test is performed to quantify total gammaglobulins, IgG and CD19+ cells (along with other tests depending on the disease). This study will use the remaining blood in the tubes from routine care to quantify CD27+ and CD38+ B cells, as well as serum rituximab and anti-rituximab antibodies, during the first year of follow-up. The primary outcome will be to identify risk factors for clinical relapse according to circulating B-cell or rituximab status.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

primary immune thrombocytopenia

primary autoimmune hemolytic anemia

systmic lupus erythematous

systemic sclerosis

Disqualifiers

Patients undergoing multiple immunosuppressive drugs because of refractory disease or concomitant hemopathy or malignancy

Trial population

Patient who undergo rituximab treatment according to routine care and having one of the following disorder: * primary immune thrombocytopenia * primary autoimmune hemolytic anemia * systmic lupus erythematous * systemic sclerosis * rheumatoid arthritis * inflammatory myopathy * ANCA associated vasculitis * Cryoglobulinemic vasculitis

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

50 Participants
are grouped into 3 trial groups
Group A: Autoimmune cytopenia (immune thrombocytopenia or hemolytic anemia)
Group B: Connective tissu disorder (SLE, myopathie, RA…)
Group C: Systemic vasculitis (ANCA, essential cryoglobulinemia)

Trial outcomes

Primary outcomes

1

Patients with (Immune Thrombocytopenia) ITP

Hematologic relapse described as a drop in platelet count below 20 G/L following a remission phase of at least 3 months with platelet count greater than 50 G/L.

Time frame
At each consultation during 5 years
2

Patients with AIHA Autoimmune Hemolytic Anemia.

Hematologic relapse described as a drop in hemoglobin level below 10 g/dL (with a lost of at least 2 g/dL from baseline) in association with hemolysis after e remission of at least 3 months

Time frame
At each consultation during 5 years
3

Patients with inflammatory myopathy

Clinical relase defined as a confirmed muscular (myalgia associated with at least one from the following : increase CK levels, new or worsening electromyography, new or worsening muscle inflammation on MRI), joint or pulmonary new symptoms related to myositis

Time frame
At each consultation during 5 years
4

Patients with systemic lupus erythematous :

Clinical relapse defined as an increase by 4 points in the SLEDAI (systemic lupus erythematous disease activity index) score

Time frame
At each consultation during 5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

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