Immunopharmacological Effects of Rituximab in Atopic Dermatitis
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|ClinicalTrials.gov Identifier: NCT00267826|
Recruitment Status : Completed
First Posted : December 21, 2005
Last Update Posted : June 17, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Dermatitis, Atopic||Drug: Rituximab||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label, Single Center Study to Evaluate the Immunopharmacological Effects of Rituximab in Patients With Atopic Dermatitis|
|Study Start Date :||December 2005|
|Actual Primary Completion Date :||June 2006|
|Actual Study Completion Date :||December 2006|
Patients with atopic dermatitis.
Intravenous infusion of 1000mg Rituximab (anti-CD20) on days 1 and 15 to patients with atopic dermatitis
- Severity score (EASI) [ Time Frame: 24 weeks ]
- Immunological parameters [ Time Frame: 24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00267826
|University of Bern, Department of Dermatology|
|Bern, Switzerland, CH-3010|
|Principal Investigator:||Hans-Uwe Simon, MD, PhD||University of Bern, Department of Pharmacology|