Rituximab therapy in anti-MAG patients with characteristics of good responders: THERAMAG study

Phase 1

• Conditions: MedDRA version: 21.1Level: LLTClassification code 10066137Term: Anti-MAG neuropathySystem Organ Class: 100000004852; Anti-MAG neuropathy; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2021-000009-25-FR
• Lead Sponsor: CHU SAINT-ETIENNE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-02
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

-Age over 18
-Disease duration of 24 months or less and documented clinical worsening (clinical or ENMG or disability) over the past 12 months
-IgM gammopathy, either MGUS or 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 ß-HCG in women of childbearing potential.
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 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

-Unable to give informed consent
-History of severe allergic or anaphylactic reaction to chimeric monoclonal antibody
-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- 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 [(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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified