Trial | NCT00189878  Report issue

Title

A Study of the Use of Methotrexate in the Treatment of Chronic Idiopathic Urticaria
Multi-centre Prospective Randomised Double-blind Placebo-controlled Study of Methotrexate in the Treatment of Chronic Idiopathic Urticaria

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    naltrexone ...

  • Study Participants

    3
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.
Study Started
Aug 31
2003
Primary Completion
Aug 31
2008
Study Completion
Aug 31
2008
Last Update
Feb 19
2016
Estimate

Drug Methotrexate (drug)

Methotrexate 10 to 15 mg weekly for 8 weeks

Drug placebo capsules

4-6 placebo capsules - identical to capsules containing methotrexate

1 methotrexate Active Comparator

patient to receive methotrexate

2 Placebo Placebo Comparator

given placebo capsules

Criteria 

Inclusion Criteria:

severe unremitting chronic idiopathic urticaria
disease resistant to treatment with antihistamines
aged 18 years or more

Exclusion Criteria:

predominant physical urticaria
urticarial vasculitis
any contraindication to the use of methotrexate, eg. pregnancy / breast feeding, women wanting to conceive or man wanting to father a child within 12 months of entry, use of drugs which interact, underlying medical conditions
use of immunosuppressant within 4 weeks of entry
No Results Posted