drugset / Trial / NCT01301703

Vaccination Against Pertussis, Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis

NCT01301703

Phase 4 Unknown 100 enrolled Tel-Aviv Sourasky Medical Center
NaSingle-groupOpen-labelPrevention

Summary

Pertussis is an acute respiratory infection caused by Bordetella pertussis. Rates of recent B. pertussis infection between 8%--26% have been reported among adults with cough illness of at least 5 days duration who sought medical care. The CDC recommends vaccinating patients aged 15 to 64 years old, once in 10 years. Although acellular vaccines such as BOOSTRIX have been evaluated in healthy population, the safety and efficacy of this vaccine in patients suffering from rheumatic diseases have not been established. Study population : 50 Rheumatoid Arthritis (RA) patients and 5 healthy controls Evaluation : the evaluation will be performed on week 0 and 4-6 weeks later. In terms of safety, the patients will be evaluated according to the Disease Activity Index (DAS). Blood will be drawn at each visit at tested for humoral response to tetanus and pertussis.

Timeline

Start
2011-03
Primary completion
2011-12
Completion
2012-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator Boostrix Vaccine 0.5 ml Intramuscular

Indications