search
Back to results

The Effect of Rituximab on the Humoral Response to Influenza Vaccine

Primary Purpose

Rheumatoid Arthritis

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Influenza vaccine
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rheumatoid Arthritis focused on measuring Rheumatoid, rituximab, influenza

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with Rheumatoid Arthritis
  • Age-18-85
  • Treatment with Rituximab and other Disease modifying drugs

Exclusion Criteria:

  • Treatment with anti TNF alpha
  • Allergy to eggs

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Efficacy of vaccination against influenza

    Secondary Outcome Measures

    Safety of vaccination against influenza in Rheumatoid Arthritis patients

    Full Information

    First Posted
    April 24, 2007
    Last Updated
    April 25, 2007
    Sponsor
    Tel-Aviv Sourasky Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00466037
    Brief Title
    The Effect of Rituximab on the Humoral Response to Influenza Vaccine
    Official Title
    Vaccination Against Influenza in Rheumatoid Arthritis Patients: The Effect of Rituximab on the Humoral Response
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2007
    Overall Recruitment Status
    Terminated
    Study Start Date
    September 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    February 2006 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Rituximab is a genetically engineered chimeric anti-CD20 monoclonal antibody that selectively targets CD20+ B cells and induces a transient depletion of the CD20+ mature B cell subpopulation.The objective of our study was to assess the effect of rituximab on the efficacy and safety of influenza virus vaccine in patients with rheumatoid arthritis (RA).
    Detailed Description
    The study population comprised RA patients treated with conventional disease modifying drugs with or without rituximab. Split-virion inactivated vaccine containing 15 mcg hemagglutinin/dose of B/Shanghai/361/02 (SHAN), A/New Caledonia A/New Caledonia/ 20/99 (NC) (H1N1) and A/California/7/04 (CAL) (H3N2) was used. Disease activity was assessed by number of tender and swollen joints, morning stiffness duration, and evaluation of pain on the day of vaccination and 4 weeks later. CD20 positive cell levels were assessed in rituximab treated patients. Hemagglutination inhibition (HI) antibodies were tested and response was defined as >4-fold rise 4 weeks post vaccination or seroconversion in patients with a non-protective baseline level of antibodies (<1/40). Geometric mean titers (GMT) were calculated in all subjects. Results: The participants were divided into 3 groups: RA (n=29, aged 64±12 years), rituximab-treated RA (n=14, aged 53±15 years) and healthy controls (n=21, aged 58±15 years). All baseline protective levels of HI antibodies and GMT were similar. Four weeks after vaccination, there was a significant increase in GMT for NC and California antigens in all subjects, but not for the Shanghai antigen in the rituximab group. Similarly, the percentage of responders was low for Shanghai and NC, but significantly lowers in rituximab treated patients for the California antigen compared with the other groups. Parameters of disease activity remained unchanged. Conclusion: Influenza virus vaccine generated a humoral response in all RA study patients and controls. Although the response was significantly lower among rituximab-treated patients,

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis
    Keywords
    Rheumatoid, rituximab, influenza

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    64 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    Influenza vaccine
    Primary Outcome Measure Information:
    Title
    Efficacy of vaccination against influenza
    Secondary Outcome Measure Information:
    Title
    Safety of vaccination against influenza in Rheumatoid Arthritis patients

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with Rheumatoid Arthritis Age-18-85 Treatment with Rituximab and other Disease modifying drugs Exclusion Criteria: Treatment with anti TNF alpha Allergy to eggs
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ori Elkayam, M.D
    Organizational Affiliation
    Tel Aviv Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Effect of Rituximab on the Humoral Response to Influenza Vaccine

    We'll reach out to this number within 24 hrs