A Phase 2 interventional study of Methotrexate (drug) and placebo capsules in Urticaria, sponsored by Barnsley Hospital. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-02-19.
Sponsored by Barnsley Hospital · Phase 2, Interventional, and Treatment
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.
237 studies on the registry are indexed under Urticaria; 26 are open to participants now.
This study's enrollment of 3 is below the median of 61 across 174 interventional studies indexed under Urticaria.
Browse Urticaria studies →Barnsley Hospital is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patient to receive methotrexate
Drug: Methotrexate (drug)
given placebo capsules
Drug: placebo capsules
Methotrexate 10 to 15 mg weekly for 8 weeks
4-6 placebo capsules - identical to capsules containing methotrexate
A positive response to treatment (a reduction to <25% of baseline urticaria activity scores)
Time frame: 8 weeks
No study locations are listed for this record.
This study is terminated, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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