A Study of the Use of Methotrexate in the Treatment of Chronic Idiopathic Urticaria

Phase 2

Terminated

• Conditions: Urticaria
• Interventions: Drug: Methotrexate (drug); Drug: placebo capsules

• Registration Number: NCT00189878
• Lead Sponsor: Barnsley Hospital

Brief Summary

The purpose of this study is to determine whether methotrexate produces significant improvement in chronic idiopathic urticaria, compared with placebo

Detailed Description

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 Timeline

• Study Start: 2003-08
• Study First Submitted: 2005-09-11
• Study First Submitted QC: 2005-09-11
• Study First Posted: 2005-09-19
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-18
• Last Update Posted: 2016-02-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1 methotrexate	Methotrexate (drug)	patient to receive methotrexate
2 Placebo	placebo capsules	given placebo capsules

Primary Outcome Measures

Name	Time	Method
A positive response to treatment (a reduction to <25% of baseline urticaria activity scores)	8 weeks