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| Sponsored by: |
Tel-Aviv Sourasky Medical Center |
|---|---|
| Information provided by: | Tel-Aviv Sourasky Medical Center |
| ClinicalTrials.gov Identifier: | NCT00466037 |
Purpose
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).
| Condition | Intervention |
|---|---|
|
Rheumatoid Arthritis |
Biological: Influenza vaccine |
| Study Type: | Interventional |
| Study Design: | Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Vaccination Against Influenza in Rheumatoid Arthritis Patients: The Effect of Rituximab on the Humoral Response |
| Estimated Enrollment: | 64 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | February 2006 |
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,
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Study ID Numbers: | TASMC-05-OE-204-CTIL |
| Study First Received: | April 24, 2007 |
| Last Updated: | April 25, 2007 |
| ClinicalTrials.gov Identifier: | NCT00466037 History of Changes |
| Health Authority: | Israel:TASMC helsinki comittee |
|
Rheumatoid rituximab influenza |
|
Autoimmune Diseases Immunologic Factors Rituximab Joint Diseases Arthritis, Rheumatoid Rheumatic Diseases Orthomyxoviridae Infections Virus Diseases |
Musculoskeletal Diseases Respiratory Tract Infections Respiratory Tract Diseases Arthritis Influenza, Human Connective Tissue Diseases Antirheumatic Agents |
|
RNA Virus Infections Autoimmune Diseases Immunologic Factors Immune System Diseases Antineoplastic Agents Rituximab Joint Diseases Physiological Effects of Drugs Arthritis, Rheumatoid Rheumatic Diseases Orthomyxoviridae Infections |
Pharmacologic Actions Virus Diseases Respiratory Tract Diseases Musculoskeletal Diseases Respiratory Tract Infections Therapeutic Uses Arthritis Influenza, Human Connective Tissue Diseases Antirheumatic Agents |
