Immunopharmacological Effects of Rituximab in Atopic Dermatitis

Sponsor
University of Bern
Study ID
NCT00267826
Status
Completed

Conditions

  • Dermatitis, Atopic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    Intravenous infusion of 1000mg Rituximab (anti-CD20) on days 1 and 15 to patients with atopic dermatitis

Study Details

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.

Key Dates

Start date
Dec 31, 2005
Status verified
Jun 2008
Primary completion
Jun 30, 2006
Completion
Dec 31, 2006

Study Design

Enrollment
6 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Patients with atopic dermatitis.

Primary Outcome Measure

Severity score (EASI) [ Time Frame: 24 weeks ]

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