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

This study has been terminated.
(unable to recruit)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00189878
First Posted: September 19, 2005
Last Update Posted: February 19, 2016
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.
Information provided by:
Barnsley Hospital
  Purpose
The purpose of this study is to determine whether methotrexate produces significant improvement in chronic idiopathic urticaria, compared with placebo

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

Study Type: Interventional
Study Design: 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

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 ]

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT00189878


Sponsors and Collaborators
Barnsley Hospital
Investigators
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
First Submitted: September 11, 2005
First Posted: September 19, 2005
Last Update Posted: February 19, 2016
Last Verified: February 2016

Keywords provided by Barnsley Hospital:
chronic idiopathic urticaria
methotrexate

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