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

Primary Purpose

Urticaria

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Methotrexate (drug)
placebo capsules
Sponsored by
Barnsley Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urticaria focused on measuring chronic idiopathic urticaria, methotrexate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    1 methotrexate

    2 Placebo

    Arm Description

    patient to receive methotrexate

    given placebo capsules

    Outcomes

    Primary Outcome Measures

    A positive response to treatment (a reduction to <25% of baseline urticaria activity scores)

    Secondary Outcome Measures

    Full Information

    First Posted
    September 11, 2005
    Last Updated
    February 18, 2016
    Sponsor
    Barnsley Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00189878
    Brief Title
    A Study of the Use of Methotrexate in the Treatment of Chronic Idiopathic Urticaria
    Official Title
    Multi-centre Prospective Randomised Double-blind Placebo-controlled Study of Methotrexate in the Treatment of Chronic Idiopathic Urticaria
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Terminated
    Why Stopped
    unable to recruit
    Study Start Date
    August 2003 (undefined)
    Primary Completion Date
    August 2008 (Actual)
    Study Completion Date
    August 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Barnsley Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urticaria
    Keywords
    chronic idiopathic urticaria, methotrexate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    3 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1 methotrexate
    Arm Type
    Active Comparator
    Arm Description
    patient to receive methotrexate
    Arm Title
    2 Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    given placebo capsules
    Intervention Type
    Drug
    Intervention Name(s)
    Methotrexate (drug)
    Intervention Description
    Methotrexate 10 to 15 mg weekly for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    placebo capsules
    Intervention Description
    4-6 placebo capsules - identical to capsules containing methotrexate
    Primary Outcome Measure Information:
    Title
    A positive response to treatment (a reduction to <25% of baseline urticaria activity scores)
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ruth A Sabroe, FRCP, MD
    Organizational Affiliation
    Barnsley Hospital NHS Foundation Trust
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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