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

This study has been terminated.
(unable to recruit)
Information provided by:
Barnsley Hospital
ClinicalTrials.gov Identifier:
First received: September 11, 2005
Last updated: February 18, 2016
Last verified: February 2016
The purpose of this study is to determine whether methotrexate produces significant improvement in chronic idiopathic urticaria, compared with placebo

Condition Intervention Phase
Drug: Methotrexate (drug)
Drug: placebo capsules
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-centre Prospective Randomised Double-blind Placebo-controlled Study of Methotrexate in the Treatment of Chronic Idiopathic Urticaria

Resource links provided by NLM:

Further study details as provided by Barnsley Hospital:

Primary Outcome Measures:
  • A positive response to treatment (a reduction to <25% of baseline urticaria activity scores) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: August 2003
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 methotrexate
patient to receive methotrexate
Drug: Methotrexate (drug)
Methotrexate 10 to 15 mg weekly for 8 weeks
Placebo Comparator: 2 Placebo
given placebo capsules
Drug: placebo capsules
4-6 placebo capsules - identical to capsules containing methotrexate

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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00189878

Sponsors and Collaborators
Barnsley Hospital
Principal Investigator: Ruth A Sabroe, FRCP, MD Barnsley Hospital NHS Foundation Trust
  More Information

Responsible Party: Jeffrey Bailey, Research and Development, Barnsley Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00189878     History of Changes
Other Study ID Numbers: MREC/03/4/003  MF 8000/12375 
Study First Received: September 11, 2005
Last Updated: February 18, 2016
Health Authority: United Kingdom: National Health Service

Keywords provided by Barnsley Hospital:
chronic idiopathic urticaria

Additional relevant MeSH terms:
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Vascular
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Physiological Effects of Drugs
Reproductive Control Agents

ClinicalTrials.gov processed this record on May 22, 2016