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Methotrexate in the Treatment of Chronic Idiopathic Urticaria (MUCIS)

Primary Purpose

Chronic Urticaria

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Methotrexate (Novatrex ®) + anti-H1
Placebo + anti-H1
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Urticaria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU BREST Morvan
  • Chu Mondor
  • Ch Le Mans
  • CHRU LILLE Huriez
  • CHRU NANCY Brabois
  • Chru Nantes
  • Hopital TENON
  • CHRU POITIERS La Miléterie
  • Chru Reims
  • CHRU RENNES Pontchaillou
  • Chru Tours

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group I

Group II

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Tolerance : clinical and biological safety
Number of patients with clinical adverse effects Number of patients with biological adverse effects
Efficacy of the treatment in improving symptoms : pruritus
Number of patients with : - pruritus At 18 weeks and 26 weeks
Persistency of the complete remission at 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
- number of outbreaks by week/patient At 18 weeks and 26 weeks
Efficacy of the treatment in improving symptoms : duration of lesions
- mean +/- standard deviation duration of lesions At 18 weeks and 26 weeks
Efficacy of the treatment in improving quality of life
Mean DLQI (quality of life) score : At 18 weeks and 26 weeks
Efficacy of the treatment in improving quality of sleep
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
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

Full Information

First Posted
January 15, 2013
Last Updated
September 19, 2017
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT01960283
Brief Title
Methotrexate in the Treatment of Chronic Idiopathic Urticaria
Acronym
MUCIS
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 2011 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Urticaria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Active Comparator
Arm Description
The group I will receive the intervention : Methotrexate + anti-H1
Arm Title
Group II
Arm Type
Placebo Comparator
Arm Description
The intervention in group II will include : placebo + anti-H1
Intervention Type
Drug
Intervention Name(s)
Methotrexate (Novatrex ®) + anti-H1
Other Intervention Name(s)
Methotrexate, Anti-H1
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo + anti-H1
Other Intervention Name(s)
Placebo of methetrexate + anti-H1
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of patients with complete remission of urticaria at 18 weeks
Description
Number of patients with complete remission of urticaria at 18 weeks, defined as no urticarial lesion 30 days before W18
Time Frame
at 18 weeks of treatment
Secondary Outcome Measure Information:
Title
Tolerance : clinical and biological safety
Description
Number of patients with clinical adverse effects Number of patients with biological adverse effects
Time Frame
18 weeks
Title
Efficacy of the treatment in improving symptoms : pruritus
Description
Number of patients with : - pruritus At 18 weeks and 26 weeks
Time Frame
18 weeks and 26 weeks
Title
Persistency of the complete remission at 26 weeks
Description
Number of patients with persistency of the complete remission, defined as no urticarial lesion from the withdrawal of treatment until W26
Time Frame
26 weeks
Title
Efficacy of the treatment in improving symptoms : outbreaks by week
Description
- number of outbreaks by week/patient At 18 weeks and 26 weeks
Time Frame
18 weeks and 26 weeks
Title
Efficacy of the treatment in improving symptoms : duration of lesions
Description
- mean +/- standard deviation duration of lesions At 18 weeks and 26 weeks
Time Frame
18 weeks and 26 weeks
Title
Efficacy of the treatment in improving quality of life
Description
Mean DLQI (quality of life) score : At 18 weeks and 26 weeks
Time Frame
18 weeks and 26 weeks
Title
Efficacy of the treatment in improving quality of sleep
Description
Mean score of quality of sleep (from 0 to 100) At 18 weeks and 26 weeks
Time Frame
18 weeks and 26 weeks
Title
Efficacy of the treatment in improving facial/cervical urticarial lesions
Description
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
Time Frame
18 weeks and 26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Annabel MARUANI, MD, PhD
Organizational Affiliation
University Hospital of Tours, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU BREST Morvan
City
Brest
ZIP/Postal Code
29000
Country
France
Facility Name
Chu Mondor
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
Ch Le Mans
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
CHRU LILLE Huriez
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
CHRU NANCY Brabois
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
Chru Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Hopital TENON
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
CHRU POITIERS La Miléterie
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Chru Reims
City
Reims
ZIP/Postal Code
51000
Country
France
Facility Name
CHRU RENNES Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
Chru Tours
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Learn more about this trial

Methotrexate in the Treatment of Chronic Idiopathic Urticaria

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