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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

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

NCT ID

NCT00802243

First Posted

December 3, 2008

Last Updated

December 3, 2008

Sponsor

University Hospital, Limoges

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

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

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

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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