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
About this trial
This is an interventional treatment trial for Urticaria focused on measuring chronic idiopathic urticaria, methotrexate
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
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
NCT ID
NCT00189878
First Posted
September 11, 2005
Last Updated
February 18, 2016
Sponsor
Barnsley Hospital
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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