Bullous PemphigoidPhase 2ARABULNCT00802243
Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid
A Phase 2 study testing leflunomide in people with Bullous Pemphigoid, run by University Hospital, Limoges at 3 sites in France.
Trial summary
Bullous pemphigoid (BP) is the most common blistering auto-immune disease of skin with an incidence estimated to 400 new cases per year. Topical corticosteroid therapy is considered the standard treatment for bullous pemphigoïd in 2002. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Bullous Pemphigoid
- What is being tested?
- leflunomide
- How many people
- 54 participants
- Where
- 3 sitesFrance
- Study dates
- Sep 2007to not given
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Adult ≥ 65 years old
- Bullous pemphigoid :
- Newly diagnosed bullous pemphigoid : No treatment or topical corticosteroids therapy for less than one month
- BP diagnosed : Resistance of the BP to the treatment or recurrence 6 months at least after diagnosis
- Follow up monthly during one year accepted
- Written Inform Consent
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Limoges University Hospital
Limoges, 87042
Christophe BEDANE, MD, 0555056430, christophe.bedane@chu-limoges.fr
Agnès SPARSA, MD
- Not yet recruiting
Bordeaux University Hospital
Pessac, 33604
Marie Sylvie DOUTRE, MD, 0557656432
Marie Sylvie DOUTRE, MD
- Not yet recruiting
Toulouse University Hospital
Toulouse, 31059
Carle PAUL, MD, 0561777675
Carle PAUL, MD
About this study
Official title: Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid. An Open Prospective Study
Bullous pemphigoid (BP) is the most common blistering auto-immune disease of skin with an incidence estimated to 400 new cases per year. Topical corticosteroid therapy is considered the standard treatment for bullous pemphigoïd in 2002. Topical corticosteroid requires an initial large hospitalization during the acute phase and rehospitalization during relapse. The usefulness of immunosuppressive drugs have suggested by uncontrolled study.
In this way, leflunomide could be an alternative therapy, and to reduce relapse and/or resistance risks.
This study could prove the efficacity of leflunomide, associated with short time topical corticosteroids.
Read the detailed description
Pre-inclusion stage: Case history, clinical examination, laboratory study, inclusion criteria checking.
Inclusion stage: Inclusion and exclusion criteria checking, clinical examination, disease follow-up, written inform consent.
Ambulatory hospitalisation, laboratory study.
Treatment and follow-up of the patients.
Clobetasol propionate cream application and leflunomide introduction.
After inclusion, the treatment will begin with 40 g topical corticosteroid per day and 20 mg leflunomide per day.
Topical corticosteroids will be progressively decreased during 5 months and stopped.
Follow-up: monthly during one year in the department of dermatology, university hospital (clinical examination, laboratory study).
- Conditions
- Bullous Pemphigoid
- Being tested
- leflunomide
- Keywords
- Bullous pemphigoid, leflunomide, corticosteroid treatment reduction, Patients are screened by: the physicians in different departments of the hospital, the liberal dermatologists and the general practicioners., Phase I: Patients will be referred to the investigators of Dupuytren Hospital Dermatology Department., Phase II: Patients will be referred to the investigators of Purpan (Toulouse), Haut Leveque (Pessac) and Dupuytren (Limoges) Hospitals.
- Medical subject headings
- Pemphigoid, Bullous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leflunomideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage 1 : complete clinical remission after 6 months treatment for 9 patients at least among 15 appraisable patients.
Stage 2 : complete clinical remission after 6 months treatment for 27 patients at least among 43 appraisable patients.
Secondary outcomes (3)
To determine the rate of clinical complete remission at M9 and M12.
To estimate the number of patients with immunological remission at M6, M9 and M12.
To evaluate monthly the tolerance of leflunomide.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullous PemphigoidStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Investigators
- Christophe BEDANE, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802243
- Sponsor's protocol ID
- 2007-003545-32
- Acronym
- ARABUL
- Status last verified
- Dec 2008
- First submitted
- 3 Dec 2008
- Last updated
- 4 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid. An Open Prospective Study
- ClinicalTrials.gov ID
- NCT00802243
- Acronym / sponsor ID
- ARABUL / 2007-003545-32
- Conditions
- Bullous Pemphigoid
- Keywords
- Bullous pemphigoid, leflunomide, corticosteroid treatment reduction, Patients are screened by: the physicians in different departments of the hospital, the liberal dermatologists and the general practicioners., Phase I: Patients will be referred to the investigators of Dupuytren Hospital Dermatology Department., Phase II: Patients will be referred to the investigators of Purpan (Toulouse), Haut Leveque (Pessac) and Dupuytren (Limoges) Hospitals.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- Sep 2007
- First posted
- 4 Dec 2008 (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.
Bullous pemphigoid (BP) is the most common blistering auto-immune disease of skin with an incidence estimated to 400 new cases per year. Topical corticosteroid therapy is considered the standard treatment for bullous pemphigoïd in 2002. Topical corticosteroid requires an initial large hospitalization during the acute phase and rehospitalization during relapse. The usefulness of immunosuppressive drugs have suggested by uncontrolled study.
In this way, leflunomide could be an alternative therapy, and to reduce relapse and/or resistance risks.
This study could prove the efficacity of leflunomide, associated with short time topical corticosteroids.
Detailed description
Pre-inclusion stage: Case history, clinical examination, laboratory study, inclusion criteria checking.
Inclusion stage: Inclusion and exclusion criteria checking, clinical examination, disease follow-up, written inform consent.
Ambulatory hospitalisation, laboratory study.
Treatment and follow-up of the patients.
Clobetasol propionate cream application and leflunomide introduction.
After inclusion, the treatment will begin with 40 g topical corticosteroid per day and 20 mg leflunomide per day.
Topical corticosteroids will be progressively decreased during 5 months and stopped.
Follow-up: monthly during one year in the department of dermatology, university hospital (clinical examination, laboratory study).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Adult ≥ 65 years old
- Bullous pemphigoid :
- Follow up monthly during one year accepted
- Written Inform Consent
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| leflunomide | Drug | – |
Primary outcome
Stage 1 : complete clinical remission after 6 months treatment for 9 patients at least among 15 appraisable patients.
Stage 2 : complete clinical remission after 6 months treatment for 27 patients at least among 43 appraisable patients.
3 secondary outcomes
To determine the rate of clinical complete remission at M9 and M12.
To estimate the number of patients with immunological remission at M6, M9 and M12.
To evaluate monthly the tolerance of leflunomide.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2008.
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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.
Christophe BEDANE, MD principal investigator
University Hospital, Limoges
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing leflunomide in people with Bullous Pemphigoid, run by University Hospital, Limoges at 3 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 6 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christophe BEDANE, MD (0555056430, christophe.bedane@chu-limoges.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage 1 : complete clinical remission after 6 months treatment for 9 patients at least among 15 appraisable patients.. The study lists 2 primary outcomes in all. 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 4 Dec 2008.