RMC Trial - A Pilot Randomised controlled trial of Methotrexate for Chronic Inflammatory Demyelinating Polyradiculoneuropathy - RMC

Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
MedDRA version: 9.1Level: SOCClassification code 10029205Term: Nervous system disorders

Registration Number: EUCTR2005-003382-16-IT

Lead Sponsor: ISTITUTO CLINICO HUMANITAS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 62

Inclusion Criteria

1-Diagnosis of CIDP by a consultant neurologist with a special interest in peripheral neuropathy 2- Chronically progressive,, stepwise, or recurrent symmetric proximal and distal weakness with or without sensory dysfunction of all extremities, developing over at least 2 months 3- Absent or reduced tendon reflexes in all extremities 4- Ongoing treatment with at least one of IVIg (equivalent to at least 0.4 g/kg every four weeks) or corticosteroid (equivalent to at least prednisolone 5 mg daily). The dose must have been stable for at least 12 weeks 5- Duration not less than 6 months 6- At least moderate disability in arms or legs (overall neuropathy disability scale (ONDS) which has been very slightly modified from the INCAT overall disability status scale 17 grade 2) and MRC grade 4 or less weakness in at least one muscle at baseline OR following reduction of steroid or IVIg dose at some time during the past 12 months 7- Fulfillment of definite or neurophysiological criteria 10 proposed by INCAT or EFNS/PNS within the past 3 years
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Pregnancy, planned pregnancy, breast feeding or unwillingness to practice contraception 2. Severe concurrent medical conditions which would prevent treatment or assessment, including significant haematological, renal, liver function (including liver enzymes >twice the upper limit of normal) or chest radiograph abnormalities 3. Alternative cause of peripheral neuropathy such as drug or toxin, hereditary neuropathy or concomitant diseases such as HIV infection, Lyme disease, chronic active hepatitis, systemic lupus erythematosus, IgM paraprotein with anti-MAG antibodies, vasculitis, hematological and non-hematological malignancies. Diabetes mellitus will not be an exclusion criterion. IgG, IgA and IgM paraproteins without anti-MAG antibodies will not be exclusion criteria. 4. Presence of neurogenic sphincter disturbance 5. Multifocal motor neuropathy (fulfilling proposed EFNS/PNS criteria Appendix 2) 6. Atypical CIDP with pure sensory or persistent unifocal impairment or significant CNS involvement 7. Immunomodulatory treatment other than IVIg or corticosteroids during the previous 12 weeks. Treatment with methotrexate at any time. 8. Participation in a controlled trial of an investigational medicinal product within the past 12 weeks