MedTrace Logo

Immunopharmacological Effects of Rituximab in Atopic Dermatitis

NCT00267826 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2008-06-17

No results posted yet for this study

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.

Conditions

  • Dermatitis, Atopic

Interventions

DRUG

Rituximab

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

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Swiss National Science Foundation

    collaborator OTHER

  • University of Bern

    lead OTHER

Principal Investigators

  • Hans-Uwe Simon, MD, PhD · University of Bern, Department of Pharmacology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2006-06-30
Completion
2006-12-31

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00267826 on ClinicalTrials.gov