Immunopharmacological Effects of Rituximab in Atopic Dermatitis
Status:
Completed
Trial end date:
2006-12-01
Target enrollment:
Participant gender:
Summary
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.
Efficacy Parameters:
Clinical parameters:
EASI Patient Assessment of Pruritus / Pruritus score Physician Global Assessment (PGA)
Photography
Laboratory analysis:
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.
Phase:
N/A
Details
Lead Sponsor:
University of Bern
Collaborators:
Hoffmann-La Roche Swiss National Science Foundation