NCT00267826

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 21, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

June 17, 2008

Status Verified

June 1, 2008

Enrollment Period

6 months

First QC Date

December 20, 2005

Last Update Submit

June 16, 2008

Conditions

Dermatitis, Atopic

Keywords

Anti-CD20 antibody treatmentAtopic dermatitisB cellsCytokinesImmunopathology

Outcome Measures

Primary Outcomes (1)

  • Severity score (EASI)

    24 weeks

Secondary Outcomes (1)

  • Immunological parameters

    24 weeks

Study Arms (1)

1

EXPERIMENTAL

Patients with atopic dermatitis.

Drug: Rituximab

Interventions

RituximabDRUG

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

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bern, Department of Dermatology

Bern, CH-3010, Switzerland

Location

Related Publications (1)

  • Simon D, Hosli S, Kostylina G, Yawalkar N, Simon HU. Anti-CD20 (rituximab) treatment improves atopic eczema. J Allergy Clin Immunol. 2008 Jan;121(1):122-8. doi: 10.1016/j.jaci.2007.11.016.

    PMID: 18206507RESULT

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Hans-Uwe Simon, MD, PhD

    University of Bern, Department of Pharmacology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2005

First Posted

December 21, 2005

Study Start

December 1, 2005

Primary Completion

June 1, 2006

Study Completion

December 1, 2006

Last Updated

June 17, 2008

Record last verified: 2008-06

Locations

CH(1)