UrticariaPhase 2NCT00189878
A Study of the Use of Methotrexate in the Treatment of Chronic Idiopathic Urticaria
A Phase 2 study testing Methotrexate (drug) in people with Urticaria, run by Barnsley Hospital.
Trial summary
The purpose of this study is to determine whether methotrexate produces significant improvement in chronic idiopathic urticaria, compared with placebo Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urticaria
- What is being tested?
- Methotrexate (drug)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Aug 2003to Aug 2008
- Phase
- Phase 2
- 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
- severe unremitting chronic idiopathic urticaria
- disease resistant to treatment with antihistamines
- aged 18 years or more
Who cannot join
- predominant physical urticaria
- urticarial vasculitis
- any contraindication to the use of methotrexate, eg. pregnancy / breast feeding, women wanting to conceive or man wanting to father a child within 12 months of entry, use of drugs which interact, underlying medical conditions
- use of immunosuppressant within 4 weeks of entry
About this study
Official title: Multi-centre Prospective Randomised Double-blind Placebo-controlled Study of Methotrexate in the Treatment of Chronic Idiopathic Urticaria
The purpose of this study is to determine whether methotrexate produces significant improvement in chronic idiopathic urticaria, compared with placebo
Read the detailed description
Chronic idiopathic urticaria is thought to affect approximately 0.1% of the population. It can be very disabling and difficult to treat. Antihistamines are the only drugs licensed for treatment of urticaria, however there is a group of severely affected patients with chronic idiopathic urticaria who fail to respond. Previous trials have shown ciclosporin to be beneficial, and small studies support the use of intravenous immunoglobulins and plasmapheresis. However, not only are these options expensive, but since chronic idiopathic urticaria may persist for years, their prolonged use may be limited by adverse effects. We have previously published a report of 2 patients who responded to methotrexate, and wish to properly evaluate the efficacy of methotrexate in the treatment of CIU.
In the first part of the study patients will be given either placebo or methotrexate for 8 weeks and in the second part of the study, non-responders will be offered open labelled methotrexate for 8 weeks.
- Conditions
- Urticaria
- Being tested
- Methotrexate (drug), placebo capsules
- Keywords
- chronic idiopathic urticaria, methotrexate
- Medical subject headings
- Urticaria, Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methotrexate (drug)Drug
Methotrexate 10 to 15 mg weekly for 8 weeks
placebo capsulesDrug
4-6 placebo capsules - identical to capsules containing methotrexate
| Study group | Role | What they receive |
|---|---|---|
| 1 methotrexate | Active comparator | patient to receive methotrexate Receives: Drug: Methotrexate (drug) |
| 2 Placebo | Placebo comparator | given placebo capsules Receives: Drug: placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
A positive response to treatment (a reduction to <25% of baseline urticaria activity scores)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startAug 2003
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: unable to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrticariaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barnsley Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Ruth A Sabroe, FRCP, MD, Principal investigator, Barnsley Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189878
- Sponsor's protocol ID
- MREC/03/4/003
- Other IDs
- MF 8000/12375
- Status last verified
- Feb 2016
- First submitted
- 11 Sep 2005
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre Prospective Randomised Double-blind Placebo-controlled Study of Methotrexate in the Treatment of Chronic Idiopathic Urticaria
- ClinicalTrials.gov ID
- NCT00189878
- Acronym / sponsor ID
- MREC/03/4/003
- Conditions
- Urticaria
- Keywords
- chronic idiopathic urticaria, methotrexate
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unable to recruit
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Barnsley HospitalUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 19 Sep 2005 (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.
The purpose of this study is to determine whether methotrexate produces significant improvement in chronic idiopathic urticaria, compared with placebo
Detailed description
Chronic idiopathic urticaria is thought to affect approximately 0.1% of the population. It can be very disabling and difficult to treat. Antihistamines are the only drugs licensed for treatment of urticaria, however there is a group of severely affected patients with chronic idiopathic urticaria who fail to respond. Previous trials have shown ciclosporin to be beneficial, and small studies support the use of intravenous immunoglobulins and plasmapheresis. However, not only are these options expensive, but since chronic idiopathic urticaria may persist for years, their prolonged use may be limited by adverse effects. We have previously published a report of 2 patients who responded to methotrexate, and wish to properly evaluate the efficacy of methotrexate in the treatment of CIU.
In the first part of the study patients will be given either placebo or methotrexate for 8 weeks and in the second part of the study, non-responders will be offered open labelled methotrexate for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 methotrexate | Active comparator | Drug: Methotrexate (drug)patient to receive methotrexate |
| 2 Placebo | Placebo comparator | Drug: placebo capsulesgiven placebo capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- severe unremitting chronic idiopathic urticaria
- disease resistant to treatment with antihistamines
- aged 18 years or more
Key exclusion criteria (4 listed)
- predominant physical urticaria
- urticarial vasculitis
- any contraindication to the use of methotrexate, eg. pregnancy / breast feeding, women wanting to conceive or man wanting to father a child within 12 months of entry, use of drugs which interact, underlying medical conditions
- use of immunosuppressant within 4 weeks of entry
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 (drug)Methotrexate 10 to 15 mg weekly for 8 weeks | Drug | 1 methotrexate |
| placebo capsules4-6 placebo capsules - identical to capsules containing methotrexate | Drug | 2 Placebo |
Primary outcome
A positive response to treatment (a reduction to <25% of baseline urticaria activity scores)
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: unable to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
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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.
Ruth A Sabroe, FRCP, MD principal investigator
Barnsley Hospital NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methotrexate (drug) in people with Urticaria, run by Barnsley Hospital.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: unable to recruit). Results are not available in the source record.
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?
A positive response to treatment (a reduction to <25% of baseline urticaria activity scores) (time frame: 8 weeks). 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 19 Feb 2016.