Intravenous immunoglobulin and intravenous methylprednisolone as optimal induction treatment in CIDP(OPTIC trial)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 96

Inclusion Criteria

Inclusion of patients is based on the presence of active disease and fulfillment of the probable or definite
EFNS/PNS criteria for CIDP. All new and untreated adult patients are eligible for the study. In addition we will include CIDP patients, treated previously, who have a disease relapse after a remission of at least 1 year, and patients who have responded to their first course of IVIg in the last three months but deteriorated afterwards.
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 96
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1)Presence of IgM paraproteinemia , anti-MAG antibodies or CIDP specific antibodies associated with poor treatment response to IVIg
2)Use of drugs associated with a demyelinating neuropathy
3)Use of any immunosuppressive or immunomodulatory drugs in previous 6 months (except for a single loading dose of IVIg within 3 months), with the exception of low dose prednisone (20 mg or less for the duration of two weeks).
4)Known serious adverse events with previous IVIg or corticosteroid treatment
5)One of more of the risk factors associated with increased risk of adverse events 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 (glomerulal filtratrion rate < 30 ml/min)
6)History of osteoporosis or osteoporotic fractures
7)Known malignancy with survival expectancy of less than 1 year
8)Bodyweight more than 120 kg
9)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
10)Cataract
11)Psychosis
12)Poor dental status
13)Legally incompetent adults
14)Lack of written informed consent

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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