Status:
COMPLETED
Immunopharmacological Effects of Rituximab in Atopic Dermatitis
Lead Sponsor:
University of Bern
Collaborating Sponsors:
Hoffmann-La Roche
Swiss National Science Foundation
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
Investigator driven study Immunopharmacological Effects of Rituximab in Atopic Dermatitis Investigators 1. Prof. Dr. Hans-Uwe Simon (Dept. of Pharmacology, University of Bern, Switzerland) 2. Dr. D...
Eligibility Criteria
Inclusion
- Must give written informed consent.
- Must be at least 18 years of age.
- Must have been diagnosed with atopic dermatitis fulfilling the diagnostic criteria of Hanfin and Rajka and having active inflammation.
- Must have a severity score of 6-9 according to Langeland and Rajka.
- Must have a PGA of "severe" or "very severe" and a pruritus score of "moderate" or "severe" at baseline.
Exclusion
- Patients with other skin diseases that might interfere with the evaluation of AD.
- Patients with severe diseases of other organ systems (e.g. cardiovascular, liver, kidney, psychiatric, neurologic) that might put the patient on risk during the study or might interfere with the evaluations (in the opinion of the investigator).
- Patient older than 65 years.
- Systemic treatment for atopic dermatitis (e. g. corticosteroids, cyclosporine, mycophenolat-mofetil, interferon-gamma, UVB, UVA, PUVA) or systemic treatment with immunosuppressive/immunomodulating substances (e.g. azathioprin, methotrexate, biologics or hyposensitization -therapy) within 28 days prior to baseline.
- Local treatment for atopic dermatitis with pimecrolimus/tacrolimus, steroids \> class III, instable use of steroids class \<III, emollients or local antiseptics/antibiotics within 14 days prior to day 1.
- Serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., pneumonia, septicemia) within 3 months prior to the first dose of Rituximab.
- History of recurrent clinically significant infection.
- Congenital or acquired immunodeficiency syndrome.
- History of or a new diagnosis or treatment of an invasive malignancy within 5 years of enrollment. Patients with a history of treated squamous cell and/or basal cell carcinomas limited to the skin are not excluded.
- For female patients, unless postmenopausal or surgically sterile, unwillingness to practice effective contraception, as defined by the investigator, during the study. The rhythm method is not to be used as the sole method of contraception. Female patients considering becoming pregnant while in the study are excluded.
- Female patients who are currently pregnant or breast-feeding.
- Current enrollment in any other investigational drug study.
- Previous participation in this study or previous studies with Rituximab.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00267826
Start Date
December 1 2005
End Date
December 1 2006
Last Update
June 17 2008
Active Locations (1)
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1
University of Bern, Department of Dermatology
Bern, Switzerland, CH-3010