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

NCT ID: NCT00189878

Last Updated: 2016-02-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2008-08-31

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.

Conditions

Urticaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1 methotrexate

patient to receive methotrexate

Group Type: ACTIVE_COMPARATOR

Methotrexate (drug)

Intervention Type: DRUG

Methotrexate 10 to 15 mg weekly for 8 weeks

2 Placebo

given placebo capsules

Group Type: PLACEBO_COMPARATOR

placebo capsules

Intervention Type: DRUG

4-6 placebo capsules - identical to capsules containing methotrexate

Interventions

Methotrexate (drug)

Methotrexate 10 to 15 mg weekly for 8 weeks

Intervention Type: DRUG

placebo capsules

4-6 placebo capsules - identical to capsules containing methotrexate

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barnsley Hospital

OTHER

Sponsor Role: lead

Responsible Party

Research and Development, Barnsley Hospital NHS Foundation Trust

Principal Investigators

Ruth A Sabroe, FRCP, MD

Role: PRINCIPAL_INVESTIGATOR

Barnsley Hospital NHS Foundation Trust

Other Identifiers

MF 8000/12375

Identifier Type: -

Identifier Source: secondary_id

MREC/03/4/003

Identifier Type: -

Identifier Source: org_study_id