Methotrexate in the Treatment of Chronic Idiopathic Urticaria

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Chronic urticaria is defined by urticarial lesions persisting at 6 weeks. The cause is not found in about 75% of cases (chronic idiopathic urticaria). The gold standard treatment consists of anti-H1 molecules. In severe cases, refractory to anti-H1, few therapeutic alternatives exist. Methotrexate, which is not expensive and often prescribed by dermatologists, has been efficiently tried in an open study on severe chronic idiopathic urticaria, and also in few case reports.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Tours
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

Patients who met the diagnostic criteria for chronic idiopathic urticaria, previously treated by

• 3 different molecules of anti-H1 or

• a combination of 2 different molecules of anti-H1 or

• 1 molecule of anti-H1 with at least a double dose for a total treatment duration of ≥ 3 months before inclusion

• With persistency of at least 7 days with urticarial lesions in the previous month

Exclusion Criteria:

• Differential diagnosis of chronic idiopathic urticaria (urticarial vasculitis)

• Treatment with montelukast or immunosuppressive drugs during the previous month

• Contraindications to methotrexate

• Allergy to methotrexate

• Treatment which are contraindicated with methotrexate

• Pregnancy, possibility of getting pregnant (no effective contraception), breastfeeding

• Anomalies in liver function (transaminases or liver failure at a rate 1.5 X normal)

• Severe renal impairment (creatinine clearance calculated by the cockcroft formula <50 ml / min)

• Chronic respiratory failure

• Active infectious chronic diseases (viral hepatitis, HIV)

• History of neoplasia

• Mental deficiency

• Involvement in another drug clinical trial