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Observational Study Assessing Outcomes, Treatment Patterns and Related Costs in Patients in Bullous Pemphigoid (EDP-PB)

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ClinicalTrials.gov Identifier: NCT02837965
Recruitment Status : Unknown
Verified July 2016 by CHU de Reims.
Recruitment status was:  Recruiting
First Posted : July 20, 2016
Last Update Posted : July 20, 2016
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Brief Summary:
The study is an observational, multi-center, prospective, non-interventional and open-label data collection study assessing outcomes, treatment patterns, adverse events and costs in patients diagnosed with bullous pemphigoid. The patient enrollment period will be 1 year with a follow-up (observation period) of 1 year for each patient. Four dermatology centres in France will participate. The hypothesis to be answered by the study is that superpotent topical corticosteroid therapy is properly used to treat bullous pemphigoid in real-world life as recommended by French guidelines and whether this treatment influences the medical costs by comparison with systemic therapies (e.g. methotrexate or prednisone).

Condition or disease Intervention/treatment
Bullous Pemphigoid Drug: treatment with topical superpotent corticosteroid therapy Drug: treatment with systemic therapy (methotrexate) Drug: treatment systemic therapy (prednisone) Drug: treatment with systemic therapy (prednisone) Drug: treatment with systemic therapy (doxycycline)

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Prospective Observational Study Assessing Outcomes, Adverse Events, Treatment Patterns and Related Costs in Patients Diagnosed With Bullous Pemphigoid
Study Start Date : April 2013
Estimated Primary Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pemphigus

Group/Cohort Intervention/treatment
diagnosed bullous pemphigoid Drug: treatment with topical superpotent corticosteroid therapy
Drug: treatment with systemic therapy (methotrexate)
Drug: treatment systemic therapy (prednisone)
Drug: treatment with systemic therapy (prednisone)
Drug: treatment with systemic therapy (doxycycline)



Primary Outcome Measures :
  1. BPDAI (bullous pemphigoid disease area index) [ Time Frame: up to one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with bullous pemphigoid
Criteria

Inclusion Criteria:

  • Written informed consent from the patient or a legally authorized representative person.
  • Patients affiliated to social security system
  • BP newly diagnosed according to the following criteria: i) suggestive clinical features; ii) histological picture of subepidermal blisters with an infiltrate of eosinophils in the superficial dermis; iii) presence of continuous, linear deposits of IgG and C3 deposits along the skin basement membrane zone by direct IF.
  • Patients: no prior superpotent topical steroid therapy or systemic treatment for BP for more than 2 weeks

Exclusion Criteria:

  • BP in relapse
  • Pemphigoid of pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837965


Contacts
Contact: Philippe Bernard 326784488 pbernard@chu-reims.fr

Locations
France
Chu Reims Recruiting
France, Reims, France, 51092
Contact: Damien JOLLY    326788472 ext 33    djolly@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims

Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT02837965     History of Changes
Other Study ID Numbers: PR12042
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: July 20, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Pemphigoid, Bullous
Skin Diseases, Vesiculobullous
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Prednisone
Doxycycline
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Anti-Bacterial Agents
Anti-Infective Agents