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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00189878
Recruitment Status : Terminated (unable to recruit)
First Posted : September 19, 2005
Last Update Posted : February 19, 2016
Information provided by:
Barnsley Hospital

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

Condition or disease Intervention/treatment Phase
Urticaria Drug: Methotrexate (drug) Drug: placebo capsules Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2003
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. A positive response to treatment (a reduction to <25% of baseline urticaria activity scores) [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00189878

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

Responsible Party: Jeffrey Bailey, Research and Development, Barnsley Hospital NHS Foundation Trust Identifier: NCT00189878     History of Changes
Other Study ID Numbers: MREC/03/4/003
MF 8000/12375
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: February 19, 2016
Last Verified: February 2016

Keywords provided by Barnsley Hospital:
chronic idiopathic urticaria

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