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

Urticaria Clinical Trial

Official title:

Multi-centre Prospective Randomised Double-blind Placebo-controlled Study of Methotrexate in the Treatment of Chronic Idiopathic Urticaria

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00189878
• Other study ID #: MREC/03/4/003
• Secondary ID: MF 8000/12375
• Status: Terminated
• Phase: Phase 2
• First received: September 11, 2005
• Last updated: February 18, 2016
• Start date: August 2003
• Est. completion date: August 2008

Study information

• Verified date: February 2016
• Source: Barnsley Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urticaria

Intervention

Drug:
• Methotrexate (drug)
Methotrexate 10 to 15 mg weekly for 8 weeks
• placebo capsules
4-6 placebo capsules - identical to capsules containing methotrexate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Barnsley Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A positive response to treatment (a reduction to <25% of baseline urticaria activity scores)		8 weeks	Yes