Chronic UrticariaPhase 3MUCISNCT01960283
Methotrexate in the Treatment of Chronic Idiopathic Urticaria
A Phase 3 study testing Methotrexate (Novatrex ®) + anti-H1 in people with Chronic Urticaria, run by University Hospital, Tours at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Urticaria
- What is being tested?
- Methotrexate (Novatrex ®) + anti-H1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 11 sitesFrance
- Study dates
- Nov 2011to May 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
CHRU BREST Morvan
Brest, 29000
Chu Mondor
Créteil, 94000
Ch Le Mans
Le Mans, 72000
CHRU LILLE Huriez
Lille, 59000
CHRU NANCY Brabois
Nancy, 54000
Chru Nantes
Nantes, 44000
Hopital TENON
Paris, 75020
CHRU POITIERS La Miléterie
Poitiers, 86000
Chru Reims
Reims, 51000
CHRU RENNES Pontchaillou
Rennes, 35000
Chru Tours
Tours, 37044
About this study
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
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.
Read the 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.
- Conditions
- Chronic Urticaria
- Being tested
- Methotrexate (Novatrex ®) + anti-H1, Placebo + anti-H1
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methotrexate (Novatrex ®) + anti-H1Drug
Also called Methotrexate, 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.
Placebo + anti-H1Drug
Also called Placebo of methetrexate + 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.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | The group I will receive the intervention :
Methotrexate + anti-H1 Receives: Drug: Methotrexate (Novatrex ®) + anti-H1 |
| Group II | Placebo comparator | The intervention in group II will include : placebo + anti-H1 Receives: Drug: Placebo + anti-H1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 18 weeks of treatment
Secondary outcomes (8)
Tolerance : clinical and biological safety
Number of patients with clinical adverse effects Number of patients with biological adverse effects
Measured: 18 weeks
Efficacy of the treatment in improving symptoms : pruritus
Number of patients with :
- pruritus At 18 weeks and 26 weeks
Measured: 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
Measured: 26 weeks
Efficacy of the treatment in improving symptoms : outbreaks by week
- number of outbreaks by week/patient At 18 weeks and 26 weeks
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 18 weeks and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startNov 2011
- Primary completionMar 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic UrticariaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annabel MARUANI, MD, PhD, Principal investigator, University Hospital of Tours, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960283
- Sponsor's protocol ID
- PHRN09-AM/MUCIS
- Acronym
- MUCIS
- Status last verified
- Sep 2017
- First submitted
- 15 Jan 2013
- Last updated
- 20 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01960283
- Acronym / sponsor ID
- MUCIS / PHRN09-AM/MUCIS
- Conditions
- Chronic Urticaria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Nov 2011 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 10 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Drug: Methotrexate (Novatrex ®) + anti-H1The group I will receive the intervention : Methotrexate + anti-H1 |
| Group II | Placebo comparator | Drug: Placebo + anti-H1The intervention in group II will include : placebo + anti-H1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- Differential diagnosis of chronic idiopathic urticaria (urticarial vasculitis)
- Treatment with montelukast or immunosuppressive drugs during the previous month
- Contraindications to methotrexate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methotrexate (Novatrex ®) + anti-H1Also: Methotrexate, 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 | Group I |
| Placebo + anti-H1Also: Placebo of methetrexate + 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. | Drug | Group II |
Primary outcome
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
8 secondary outcomes
Tolerance : clinical and biological safety
Time frame: 18 weeks
Efficacy of the treatment in improving symptoms : pruritus
Time frame: 18 weeks and 26 weeks
Persistency of the complete remission at 26 weeks
Time frame: 26 weeks
Efficacy of the treatment in improving symptoms : outbreaks by week
Time frame: 18 weeks and 26 weeks
Efficacy of the treatment in improving symptoms : duration of lesions
Time frame: 18 weeks and 26 weeks
Efficacy of the treatment in improving quality of life
Time frame: 18 weeks and 26 weeks
Efficacy of the treatment in improving quality of sleep
Time frame: 18 weeks and 26 weeks
Efficacy of the treatment in improving facial/cervical urticarial lesions
Time frame: 18 weeks and 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annabel MARUANI, MD, PhD principal investigator
University Hospital of Tours, France
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methotrexate (Novatrex ®) + anti-H1 in people with Chronic Urticaria, run by University Hospital, Tours at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with complete remission of urticaria at 18 weeks (time frame: at 18 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2017.