Rituximab in bullous pemphigoid

Phase 4

Completed

• Conditions: Bullous pemphigoid; Skin - Dermatological conditions

• Registration Number: ACTRN12607000104459
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-02-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

No severe infection requiring systemic antibiotics, failed to respond to systemic steroids or requiring doses of >10mg prednisolone per day or requiring systemic immunosuppression or unable to tolerate oral steroids.

Exclusion Criteria

WHO performance status >3, unable to comprehend patient information and consent form.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients response rate[Measured at 1 and 3 months after rituximab administration and 3-monthly therafter until completion of study. Completion of study was at 17 months post rituximab but in one patient, follow-up was ceased at 13 months post rituximab when they demonstrated clinical remission.]

Secondary Outcome Measures

Name	Time	Method
Complete or partial response, reponse duration, % patients able to discontinue steroids, toxicity, reduction in skin antibody levels.[These secondary outcomes were measured at 1 and 3 months post rituximab and 3-monthly therafter until study completion. Completion of study was at 17 months post rituximab but in one patient, follow-up was ceased at 13 months post rituximab when they demonstrated clinical remission]