Methotrexate in the Treatment of Chronic Idiopathic Urticaria

NCT01960283 | Completed Phase 3 DMC

• 1 other identifier: PHRN09-AM/MUCIS
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Chronic Urticaria

Outcome Measures

Primary Outcomes (1)

• Number of patients with complete remission of urticaria at 18 weeks

  Number of patients with complete remission of urticaria at 18 weeks, defined as no urticarial lesion 30 days before W18

  at 18 weeks of treatment

Secondary Outcomes (8)

• Tolerance : clinical and biological safety

  18 weeks

• Efficacy of the treatment in improving symptoms : pruritus

  18 weeks and 26 weeks

• Persistency of the complete remission at 26 weeks

  26 weeks

• Efficacy of the treatment in improving symptoms : outbreaks by week

  18 weeks and 26 weeks

• Efficacy of the treatment in improving symptoms : duration of lesions

  18 weeks and 26 weeks

Study Arms (2)

Group I

ACTIVE COMPARATOR

The group I will receive the intervention : Methotrexate + anti-H1

Drug: Methotrexate (Novatrex ®) + anti-H1

Group II

PLACEBO COMPARATOR

The intervention in group II will include : placebo + anti-H1

Drug: Placebo + anti-H1

Interventions

Methotrexate (Novatrex ®) + anti-H1 DRUG

Methotrexate (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.

Also known as: Methotrexate, Anti-H1

Group I

Placebo + anti-H1 DRUG

Placebo: 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.

Also known as: Placebo of methetrexate + anti-H1

Group II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who met the diagnostic criteria for chronic idiopathic urticaria, previously treated by
• different molecules of anti-H1 or
• a combination of 2 different molecules of anti-H1 or
• With persistency of at least 7 days with urticarial lesions in the previous month

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (11)

CHRU BREST Morvan

Brest, 29000, France

Location

Chu Mondor

Créteil, 94000, France

Location

Ch Le Mans

Le Mans, 72000, France

Location

CHRU LILLE Huriez

Lille, 59000, France

Location

CHRU NANCY Brabois

Nancy, 54000, France

Location

Chru Nantes

Nantes, 44000, France

Location

Hopital TENON

Paris, 75020, France

Location

CHRU POITIERS La Miléterie

Poitiers, 86000, France

Location

Chru Reims

Reims, 51000, France

Location

CHRU RENNES Pontchaillou

Rennes, 35000, France

Location

Chru Tours

Tours, 37044, France

Location

MeSH Terms

Conditions

Chronic Urticaria

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Annabel MARUANI, MD, PhD

  University Hospital of Tours, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: October 10, 2013
• Study Start: November 1, 2011
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 20, 2017

Record last verified: 2017-09

Locations

FR (11)