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

Overview

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

Full Title of Study: “Multi-centre Prospective Randomised Double-blind Placebo-controlled Study of Methotrexate in the Treatment of Chronic Idiopathic Urticaria”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2008

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.

Interventions

  • Drug: Methotrexate (drug)
    • Methotrexate 10 to 15 mg weekly for 8 weeks
  • Drug: placebo capsules
    • 4-6 placebo capsules – identical to capsules containing methotrexate

Arms, Groups and Cohorts

  • Active Comparator: 1 methotrexate
    • patient to receive methotrexate
  • Placebo Comparator: 2 Placebo
    • given placebo capsules

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Barnsley Hospital
  • Provider of Information About this Clinical Study
    • Jeffrey Bailey, Research and Development, Barnsley Hospital NHS Foundation Trust
  • Overall Official(s)
    • Ruth A Sabroe, FRCP, MD, Principal Investigator, Barnsley Hospital NHS Foundation Trust

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.