Immunopharmacological Effects of Rituximab in Atopic Dermatitis
Protocol Title: Immunopharmacological effects of Rituximab in atopic dermatitis
Study Phase: Investigator driven study
Study Design: Open-label, single center.
Primary Study Objective: To determine the efficacy, safety and immunopharmacological effects of Rituximab (anti-CD20) administered as a 1000mg intravenous infusion on days 1 and 15 to patients with atopic dermatitis.
Secondary Study Objective: To investigate key immunological parameters involved in the pathology of this common skin disease to interpret the clinical findings.
Number of Patients: 6
Study Population: Male and female patients, at least 18 years of age with atopic dermatitis, active inflammation, a severity score of 6-9 according to Langeland and Rajika.
Treatment Group: Rituximab will be administered as 1000 mg infusion intravenously at day 1 and 15, followed by a 24-week follow-up period.
Visit Schedule: Screening Visit (within 28 days prior to Visit 1) Treatment visits (Visits days 1, 3, 8, 15, 17) Follow-up Visits (Visits weeks 4, 8, 12, 16, 20, 24)
Visit 11/Early Termination Visit (if applicable) Visit 11 will serve as the Early Termination Visit for any patient who withdraws from the study between Visit 1 and 10.
EASI Patient Assessment of Pruritus / Pruritus score Physician Global Assessment (PGA) Photography
Differential blood count Total IgE, specific IgE (aeroallergen panel) Immunophenotyping of PBMC Lymphocyte proliferation following pan-T stimulation with PHA Cytokine release from blood T cells following pan-T stimulation with PHA
Skin tests Histopathology of skin biopsies
Safety Parameters: Physical examinations; vital signs; selected blood chemistry, including liver function tests, creatinine; white blood cell count (WBC; including total lymphocyte count); platelets, lymphocyte subset analysis; complement, immunoglobulins (IgA, IgM, IgG, IgE), monitoring for infections; monitoring for concomitant therapies; monitoring for adverse events.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-Label, Single Center Study to Evaluate the Immunopharmacological Effects of Rituximab in Patients With Atopic Dermatitis|
- Severity score (EASI) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Immunological parameters [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||December 2005|
|Study Completion Date:||December 2006|
|Primary Completion Date:||June 2006 (Final data collection date for primary outcome measure)|
Patients with atopic dermatitis.
Intravenous infusion of 1000mg Rituximab (anti-CD20) on days 1 and 15 to patients with atopic dermatitis
Other Name: Rituximab
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|University of Bern, Department of Dermatology|
|Bern, Switzerland, CH-3010|
|Principal Investigator:||Hans-Uwe Simon, MD, PhD||University of Bern, Department of Pharmacology|