Observational Study Assessing Outcomes, Treatment Patterns and Related Costs in Patients in Bullous Pemphigoid

NCT02837965 | Completed

• 1 other identifier: PR12042*
• Study Type: observational
• Target: 149
• Locations: 1 country
• Sites: 1

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).

Conditions

Bullous Pemphigoid

Outcome Measures

Primary Outcomes (1)

• BPDAI (bullous pemphigoid disease area index)

  up to one year

Study Arms (1)

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)

Interventions

treatment with topical superpotent corticosteroid therapy DRUG

diagnosed bullous pemphigoid

treatment with systemic therapy (methotrexate) DRUG

diagnosed bullous pemphigoid

treatment systemic therapy (prednisone) DRUG

diagnosed bullous pemphigoid

treatment with systemic therapy (prednisone) DRUG

diagnosed bullous pemphigoid

treatment with systemic therapy (doxycycline) DRUG

diagnosed bullous pemphigoid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with bullous pemphigoid

You may qualify if:

• 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

You may not qualify if:

• BP in relapse
• Pemphigoid of pregnancy

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

MeSH Terms

Conditions

Pemphigoid, Bullous

Interventions

Therapeutics; Methotrexate; Prednisone; Doxycycline

Condition Hierarchy (Ancestors)

Skin Diseases, Vesiculobullous; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: July 20, 2016
• Study Start: September 26, 2013
• Primary Completion: July 12, 2018
• Study Completion: December 31, 2018
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

FR (1)