Initial treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) - combined immunoglobulin and steroid treatment versus immunoglobulin treatment alone.
- Conditions
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)MedDRA version: 21.1Level: PTClassification code 10057645Term: Chronic inflammatory demyelinating polyradiculoneuropathySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2017-002511-34-GB
- Lead Sponsor
- Academic Medical Centre, Amsterdam,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 96
1) Probable or definite CIDP according to the EFNS/PNS criteria 2010 (all CIDP phenotypes).
2) Age = 18 years.
3a) Treatment naïve patients (no previous immune treatment for CIDP); or
3b) Previously immune-treated patients who have a relapse after a remission of at least 1 year; or
3c) Patients treated with subjective or objective improvement after a single loading course of IVIg in the last 3 months, and subsequent deterioration as judged by their treating physician.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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 10
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 or low dose prednisolone (20 mg or less) during a short period (maximum 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 (glomerular filtration rate < 30 ml/min).
6) History of osteoporosis or osteoporotic fractures.
7) Known active malignancy, currently treated with chemotherapy or immunomodulatory drugs, or with a life 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 (from menarche until 1 year after the last period, surgical menopause or sterilization procedure) either not using or not willing to use a medically reliable method of contraception for the entire duration of the study.
10) Known cataract or cataract obvious on fundoscopy.
11) Current psychosis or past history of psychosis.
12) Poor dental status.
13) Known pulmonary embolism or other deep venous thrombosis in patient’s medical history, without current anticoagulant therapy.
14) Patient lacking capacity to consent to enter the trial.
15) 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