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
About this trial
This is an interventional prevention trial for Rheumatoid Arthritis focused on measuring Rheumatoid, rituximab, influenza
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
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
NCT ID
NCT00466037
First Posted
April 24, 2007
Last Updated
April 25, 2007
Sponsor
Tel-Aviv Sourasky Medical Center
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
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