Urticaria Clinical Trial
Official title:
Multi-centre Prospective Randomised Double-blind Placebo-controlled Study of Methotrexate in the Treatment of Chronic Idiopathic Urticaria
The purpose of this study is to determine whether methotrexate produces significant improvement in chronic idiopathic urticaria, compared with placebo
Chronic idiopathic urticaria is thought to affect approximately 0.1% of the population. It
can be very disabling and difficult to treat. Antihistamines are the only drugs licensed for
treatment of urticaria, however there is a group of severely affected patients with chronic
idiopathic urticaria who fail to respond. Previous trials have shown ciclosporin to be
beneficial, and small studies support the use of intravenous immunoglobulins and
plasmapheresis. However, not only are these options expensive, but since chronic idiopathic
urticaria may persist for years, their prolonged use may be limited by adverse effects. We
have previously published a report of 2 patients who responded to methotrexate, and wish to
properly evaluate the efficacy of methotrexate in the treatment of CIU.
In the first part of the study patients will be given either placebo or methotrexate for 8
weeks and in the second part of the study, non-responders will be offered open labelled
methotrexate for 8 weeks.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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