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Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid (ARABUL)

Primary Purpose

Bullous Pemphigoid

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
leflunomide
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bullous Pemphigoid focused on measuring 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.

Eligibility Criteria

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • None

Sites / Locations

  • Limoges University HospitalRecruiting
  • Bordeaux University Hospital
  • Toulouse University Hospital

Outcomes

Primary Outcome Measures

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 Outcome Measures

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.

Full Information

First Posted
December 3, 2008
Last Updated
December 3, 2008
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT00802243
Brief Title
Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid
Acronym
ARABUL
Official Title
Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid. An Open Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Limoges

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
leflunomide
Primary Outcome Measure Information:
Title
Stage 1 : complete clinical remission after 6 months treatment for 9 patients at least among 15 appraisable patients.
Title
Stage 2 : complete clinical remission after 6 months treatment for 27 patients at least among 43 appraisable patients.
Secondary Outcome Measure Information:
Title
To determine the rate of clinical complete remission at M9 and M12.
Title
To estimate the number of patients with immunological remission at M6, M9 and M12.
Title
To evaluate monthly the tolerance of leflunomide.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe BEDANE, MD
Phone
0555056430
Email
christophe.bedane@chu-limoges.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe BEDANE, MD
Organizational Affiliation
University Hospital, Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
Limoges University Hospital
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe BEDANE, MD
Phone
0555056430
Email
christophe.bedane@chu-limoges.fr
First Name & Middle Initial & Last Name & Degree
Agnès SPARSA, MD
First Name & Middle Initial & Last Name & Degree
Jean Marie BONNETBLANC, MD
First Name & Middle Initial & Last Name & Degree
Julie CENDRAS, MD
Facility Name
Bordeaux University Hospital
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Sylvie DOUTRE, MD
Phone
0557656432
First Name & Middle Initial & Last Name & Degree
Marie Sylvie DOUTRE, MD
Facility Name
Toulouse University Hospital
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carle PAUL, MD
Phone
0561777675
First Name & Middle Initial & Last Name & Degree
Carle PAUL, MD

12. IPD Sharing Statement

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Leflunomide Associated With Topical Corticosteroids for Bullous Pemphigoid

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