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Methotrexate in the Treatment of Chronic Idiopathic Urticaria (MUCIS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01960283
First Posted: October 10, 2013
Last Update Posted: September 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Tours
  Purpose
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.

Condition Intervention Phase
Chronic Urticaria Drug: Methotrexate (Novatrex ®) + anti-H1 Drug: Placebo + anti-H1 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Evaluating the Efficacy of Methotrexate in Addition to Anti-H1 Versus Placebo and Anti-H1 in the Treatment of Severe Chronic Idiopathic Urticaria

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • Number of patients with complete remission of urticaria at 18 weeks [ Time Frame: at 18 weeks of treatment ]
    Number of patients with complete remission of urticaria at 18 weeks, defined as no urticarial lesion 30 days before W18


Secondary Outcome Measures:
  • Tolerance : clinical and biological safety [ Time Frame: 18 weeks ]
    Number of patients with clinical adverse effects Number of patients with biological adverse effects

  • Efficacy of the treatment in improving symptoms : pruritus [ Time Frame: 18 weeks and 26 weeks ]

    Number of patients with :

    - pruritus At 18 weeks and 26 weeks


  • Persistency of the complete remission at 26 weeks [ Time Frame: 26 weeks ]
    Number of patients with persistency of the complete remission, defined as no urticarial lesion from the withdrawal of treatment until W26

  • Efficacy of the treatment in improving symptoms : outbreaks by week [ Time Frame: 18 weeks and 26 weeks ]
    - number of outbreaks by week/patient At 18 weeks and 26 weeks

  • Efficacy of the treatment in improving symptoms : duration of lesions [ Time Frame: 18 weeks and 26 weeks ]
    - mean +/- standard deviation duration of lesions At 18 weeks and 26 weeks

  • Efficacy of the treatment in improving quality of life [ Time Frame: 18 weeks and 26 weeks ]

    Mean DLQI (quality of life) score :

    At 18 weeks and 26 weeks


  • Efficacy of the treatment in improving quality of sleep [ Time Frame: 18 weeks and 26 weeks ]
    Mean score of quality of sleep (from 0 to 100) At 18 weeks and 26 weeks

  • Efficacy of the treatment in improving facial/cervical urticarial lesions [ Time Frame: 18 weeks and 26 weeks ]

    Number of patients with, either :

    • facial/cervical urticarial lesions
    • urticarial lesions on the body only
    • facial/cervical + body lesions Indeed, facial or cervical urticarial lesions are considered more disturbing. At W18 and W26


Enrollment: 83
Actual Study Start Date: November 2011
Study Completion Date: May 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group I

The group I will receive the intervention :

Methotrexate + anti-H1

Drug: Methotrexate (Novatrex ®) + anti-H1

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.

Other Names:
  • Methotrexate
  • Anti-H1
Placebo Comparator: Group II
The intervention in group II will include : placebo + anti-H1
Drug: Placebo + anti-H1

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.

Other Name: Placebo of methetrexate + anti-H1

Detailed Description:

Chronic urticaria, defined by its persistence beyond 6 weeks, is a common condition (0.1% to 3% of the general population), occurring at any age. The etiology is not found in nearly 75% of cases (chronic idiopathic urticaria). Chronic idiopathic urticaria may resolve over several months or years. The quality of life of patients is usually strongly spoiled. The gold standard treatment consist of anti-H1 molecules. In severe cases, which are refractory to anti-H1, few therapeutic alternatives exist. Two studies have shown a benefit when adding to anti-H1, montelukast, anti-leukotriene, or cyclosporine. Methotrexate, which is another immunosuppressive drug, cheap and commonly prescribed by dermatologists, has been efficient in severe chronic urticaria, in an open study and in few case reports.

Methotrexate, an anti-metabolite drug which inhibits dihydrofolate reductase, is indicated in hematologic malignancies and in autoimmune diseases. It may be given by oral or parenteral administration, once a week, and requires regular monitoring of renal and hepatic function, and blood count.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01960283


Locations
France
CHRU BREST Morvan
Brest, France, 29000
Chu Mondor
Créteil, France, 94000
Ch Le Mans
Le Mans, France, 72000
CHRU LILLE Huriez
Lille, France, 59000
CHRU NANCY Brabois
Nancy, France, 54000
Chru Nantes
Nantes, France, 44000
Hopital TENON
Paris, France, 75020
CHRU POITIERS La Miléterie
Poitiers, France, 86000
Chru Reims
Reims, France, 51000
CHRU RENNES Pontchaillou
Rennes, France, 35000
Chru Tours
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: Annabel MARUANI, MD, PhD University Hospital of Tours, France
  More Information

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT01960283     History of Changes
Other Study ID Numbers: PHRN09-AM/MUCIS
First Submitted: January 15, 2013
First Posted: October 10, 2013
Last Update Posted: September 20, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors