Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in CIDP
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
All participants are treated with intravenous IVIg, which is considered standard care. In addition, participants are randomized to receive either 7 infusions methylprednisolone (IVMP) 1000 mg in sodium chloride 0,9%, or placebo (100 ml sodium chloride 0,9%). Participants are treated every 3 weeks during an 18-week intervention period. In addition, all patients receive osteoporosis prophylactics (calcium/vitamin D 500 mg/800IE daily and alendronic acid 80 mg weekly) during the 18 week intervention period. In the Netherlands the first treatment is given in the hospital and the remaining six infusions are given at home. Outpatient clinic visits are planned every 6 weeks during the intervention period and a consultation by phone is planned 3 weeks after start of intervention period. Three follow-up visits are planned in week 24, 52 and 104. Unscheduled visits can be planned at any time during study. A total of 14 hospitals (8 in The Netherlands and 6 in the United Kingdom) are participating in this trial. The Academic Medical Center (AMC) in Amsterdam (The Netherlands) is the study sponsor.
1. Probable or definite CIDP according to the EFNS/PNS criteria 2010 (all CIDP phenotypes) 2. Age ≥ 18 years 3.1. Treatment naïve patients; or 3.2. Previously treated patients who have a relapse after a remission of at least 1 year; or 3.3. Patients treated with subjective or objective improvement after a single loading dose of IVIg in the last 3 months, and subsequent deterioration as judged by his or her treating physician.
Current exclusion criteria as of 22/11/2022: 1. Presence of IgM paraproteinemia and/or anti-MAG antibodies or known CIDP-specific antibodies associated with poor treatment response to IVIg 2. Use of drugs known to cause a demyelinating neuropathy 3. Use of any immunosuppressive or immunomodulatory drugs in the previous 6 months (except for a single loading dose of IVIg within 3 months or low dose prednisolone (20 mg or less) for a short period not exceeding two weeks) 4. Known serious adverse events (SAEs) with previous IVIg or corticosteroid treatment. Hypersensitivity to methylprednisolone or any component of the formulation. Hypersensitivity to the human immunoglobulins or to any of the excipients. Selective IgA deficiency patients who developed antibodies to IgA 5. Systemic fungal infections, unless specific anti-infective therapy is employed 6. Known hyperprolinaemia type I or II or known fructose intolerance 7. One or more of the risk factors associated with increased risk of AEs of IVIg or IVMP or conditions that could lead to unblinding of treatment (i.e. diabetes; IgA deficiency; gastric ulcers; psychosis; severe hypertension (180/110 mmHg or more on repeated measurements); hypocalcaemia (lower than 2.20 mmol/L, corrected for albumin); moderate or severe heart failure; severe cardiovascular disease (i.e. more than one myocardial infarction and or ischemic stroke); renal failure (glomerular filtration rate < 30 ml/min) 8. History of osteoporosis or osteoporotic fractures 9. Known active malignancy, currently treated with chemotherapy or immunomodulatory drugs, or with a life expectancy of less than one year 10. Bodyweight more than 120 kg 11. Pregnancy or nursing mother; intention to become pregnant during the course of the study; female patients of childbearing potential either not using or not willing to use a medically reliable method of contraception for the entire duration of the study. A woman is considered of childbearing potential from menarche and