NCT00466037

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).

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Sep 2005

Shorter than P25 for not_applicable rheumatoid-arthritis

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2007

Completed
Last Updated

April 27, 2007

Status Verified

April 1, 2007

First QC Date

April 24, 2007

Last Update Submit

April 25, 2007

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoidrituximabinfluenza

Outcome Measures

Primary Outcomes (1)

  • Efficacy of vaccination against influenza

Secondary Outcomes (1)

  • Safety of vaccination against influenza in Rheumatoid Arthritis patients

Interventions

Influenza vaccineBIOLOGICAL

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Treatment with anti TNF alpha
  • Allergy to eggs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, RheumatoidInfluenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesRespiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Ori Elkayam, M.D

    Tel Aviv Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 24, 2007

First Posted

April 27, 2007

Study Start

September 1, 2005

Study Completion

February 1, 2006

Last Updated

April 27, 2007

Record last verified: 2007-04