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

Completed

Conditions: Inflammatory Demyelinating Polyradiculoneuropathy
Nervous System Diseases
Inflammatory polyneuropathy

Registration Number: ISRCTN73774524

Lead Sponsor: King's College London and Guy's and St Thomas' NHS Foundation Trust (Co-Sponsors) (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

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 4 weeks) or corticosteroid (equivalent to at least prednisolone 5 mg daily). The dose must have been stable (within 25%) for at least 12 weeks.
5. Duration not less than 6 months
6. At least moderate disability and weakness in arms or legs according to defined criteria at baseline OR following reduction of steroid or IVIg dose at some time during the past year
7. Fulfillment of one of two sets of defined neurophysiological criteria at baseline or within the past 3 years

Exclusion Criteria

1. Age <18 years
2. Breast-feeding, pregnancy, planned pregnancy or unwillingness to practice contraception
3. Severe concurrent medical conditions which would prevent treatment or assessment, including significant haematological, renal, liver function or chest radiograph abnormalities
4. Alternative cause of peripheral neuropathy, such as drug or toxin, hereditary neuropathy or concomitant diseases such as human immunodeficiency virus (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.
5. Presence of sphincter disturbance
6. Multifocal motor neuropathy (fulfilling defined criteria)
7. Atypical CIDP with pure sensory, persistent unifocal impairment or significant central nervous system (CNS) involvement
8. Immunomodulatory treatment other than IVIg or corticosteroids during the previous 12 weeks

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage change in mean weekly dose of corticosteroid or IVIg during weeks 37?40 compared with weeks 1?4.

Secondary Outcome Measures

Name	Time	Method
1. Overall, and average rate of, change of a 12?point overall neuropathy disability score at grade 16 and 40 weeks compared with baseline<br>2. Overall, and average rate of, change in the Amsterdam Linear Disability Scale after 16 and 40 weeks<br>3. Overall, and average rate of, change in MRC sum score, expanded to include first dorsal interosseus and extensor hallucis longus, after 16 and 40 weeks<br>4. Serious adverse events (defined as those which are fatal, life-threatening, or require or prolong hospital admission) which are possibly or probably related to treatment