Rituximab Therapy in Anti-Myelin Associated Glycoprotein Patients With Characteristics of Good Responders
NCT ID: NCT05136976
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
90 participants
INTERVENTIONAL
2023-06-29
2028-12-31
Brief Summary
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Detailed Description
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In COFRAMAG study, the largest cohort worldwide of anti-MAG patients, predictors of clinical response to rituximab were identified through analysis of 92 treated patients: shorter disease duration and anti-MAG titre above 10000 BTU. Thus this study will focus on rituximab efficacy in a subset of patients with disease duration of less than 2 years and anti-MAG titre above 10000 Buhlmann Titer Units (BTU). The investigators selected Inflammatory Rasch-built Overall Disability Scale (I-RODS) as primary outcome measure because its responsiveness was proven higher than INCAT/ Overall Neuropathy Limitation Score (ONLS) scales to detect clinical meaningful changes in newly treated patients with inflammatory neuropathies.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Patient with anti-MAG neuropathy will be included. They will randomized in placebo or Rituximab group.
They will have the same premedications prior to rituximab or placebo infusions:
* IV Dexchlorpheniramine Maleate IV: 10 mg
* IV Methylprednisolone: 40 mg
* PO Paracetamol : 1 gram
Placebo infusion
2 infusions of placebo at a 2 week interval.
Premedications
Premedications prior to rituximab or placebo infusions:
* IV Dexchlorpheniramine Maleate IV: 10 mg
* IV Methylprednisolone: 40 mg
* PO Paracetamol : 1 gram
Rituximab
Patient with anti-MAG neuropathy will be included. They will randomized in placebo or Rituximab group.
They will have the same premedications prior to rituximab or placebo infusions:
* IV Dexchlorpheniramine Maleate IV: 10 mg
* IV Methylprednisolone: 40 mg
* PO Paracetamol : 1 gram
Rituximab infusion
2 infusions of 1 gram of rituximab at a 2 week interval (day 1 followed by day 15).
Premedications
Premedications prior to rituximab or placebo infusions:
* IV Dexchlorpheniramine Maleate IV: 10 mg
* IV Methylprednisolone: 40 mg
* PO Paracetamol : 1 gram
Interventions
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Rituximab infusion
2 infusions of 1 gram of rituximab at a 2 week interval (day 1 followed by day 15).
Placebo infusion
2 infusions of placebo at a 2 week interval.
Premedications
Premedications prior to rituximab or placebo infusions:
* IV Dexchlorpheniramine Maleate IV: 10 mg
* IV Methylprednisolone: 40 mg
* PO Paracetamol : 1 gram
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* IgM gammopathy, either MGUS or Waldenstrom Macroglobulinemia (WM)
* Demyelinating polyneuropathy according to European Federation of Neurological Societies/Peripheral Nerve Society guidelines for chronic inflammatory demyelinating polyneuropathy on nerve conduction studies.
* Anti-MAG titre of 10 000 BTU or more
* Total INCAT score of 1 point or more at baseline
* Absence of immunoglobulin treatment within 3 months prior to inclusion.
* Absence of immunosuppressive therapy within 6 months prior to inclusion, including steroid therapy of 2 months or more as part of the management of neuropathy.
* Negative β-human chorionic gonadotropin (HCG) in women of childbearing potential
* Women of childbearing potential must agree to use contraception for 365 days following administration of rituximab.
Exclusion Criteria
* History of severe allergic or anaphylactic reaction to chimeric monoclonal antibody
* Hypersensitivity known to one of the compounds of polaramine or methylprednisolone
* Previous treatment with rituximab
* Diseases known to cause polyneuropathy (e.g. diabetes, uncontrolled thyroid disease, vitamin B1 or B12 deficiency, renal (GFR \< 60ml ml/min/1,73 m2- Modification of Diet in Renal Disease (MDRD) formula) or liver disorder, myeloma, amyloidosis, cryoglobulinemia)
* Indication of specific immunosuppressive therapy for WM
* Significant uncontrolled disease at baseline such as cardiovascular (including cardiac arrhythmia), pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine or gastrointestinal or any other significant disease that may prevent patient from participating in the study
* Congestive heart failure (NYHA III or IV)
* Known active bacterial, viral, fungal mycobacterial infection
* History or known presence of recurrent or chronic infection (e.g. viral hepatitis, HIV syphilis, tuberculosis).
* History of cancer, including solid tumors and haematological malignancies (except basal cell and in situ squamous carcinoma of the skin, in situ carcinoma of the cervix of the uterus that have been excised and resolved, with documented clear margins on pathology)
* History of alcohol (more than two drinks a day for a woman, more than 4 glasses a day for a man \[World Health Organization (WHO) definition\]) or other drug abuse within 6 months prior to randomization
* History or currently active primary or secondary immunodeficiency
* White blood cell count \< 1500/mm3 or platelet count \< 75 000/mm3
* Angle closure glaucoma,
* Urinary retention related to urethroprostatic disorders,
* Uncontrolled psychotic disorders,
* Severe liver failure,
* Recent vaccination with live vaccines (\<3months) and vaccination with live virus vaccines is not recommended during the overall study period.
18 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Anne-Laure KAMINSKY, MD
Role: PRINCIPAL_INVESTIGATOR
CHU de Saint-Etienne
Locations
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CHU Brest - La cavale blanche
Brest, , France
CHU Grenoble - La tronche
Grenoble, , France
CHU Lille - Roger Salengro
Lille, , France
CHU Limoges - Dupuytren
Limoges, , France
HCL lyon
Lyon, , France
CHU La Timone - APHM
Marseille, , France
CHU Nancy- Hôpital central
Nancy, , France
Hôtel-Dieu et Hôpital GR Laënnec - CHU Nantes
Nantes, , France
CHU Nice - Pasteur
Nice, , France
APHP Pitié Salpêtrière
Paris, , France
APHP - Kremlin-Bicêtre
Paris, , France
CHU de Saint-Etienne
Saint-Etienne, , France
CHU Strasbourg - Hautepierre
Strasbourg, , France
CHU Toulouse - Pierre-Paul Riquet
Toulouse, , France
CHU Tours - Bretonneau
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021-000009-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
19PH226
Identifier Type: -
Identifier Source: org_study_id
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