Chronic Urticaria | Methotrexate in the Treatment of Chronic Idiopathic Urticaria
Chronic Urticaria research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Methotrexate (Novatrex ®) + anti-H1Methotrexate (Novatrex ®) tablets 2.5 mg methotrexate 0.2 mg/kg/week as a single dose, orally for 8 weeks. After 8 weeks, if the treatment is still not efficient, the dose will be increased to 0.25 mg/kg/week and continued until W18. For anti-H1 treatment, the same molecules with the same dosage than before the recruitment will be continued, and methotrexate will be added in this group.
Drug:Placebo + anti-H1Placebo: 0.2 mg / kg / week as a single dose, orally for 8 weeks. After eight weeks, if the patient is still very embarrassed, the dose is increased to 0.25 mg / kg / week in a weekly dose. For anti-H1 treatment, the same molecules with the same dosage than before the recruitment will be continued, and the placebo of methotrexate will be added in this group.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Group IThe group I will receive the intervention : Methotrexate + anti-H1
Group IIThe intervention in group II will include : placebo + anti-H1
Start Date: November 2011
Completed Date: May 2016
Phase: Phase 3
Primary Outcome: Number of patients with complete remission of urticaria at 18 weeks
Secondary Outcome: Tolerance : clinical and biological safety
Study sponsors, principal investigator, and references
Principal Investigator: Annabel MARUANI, MD, PhD
Lead Sponsor: University Hospital, Tours