To estimate the rate of immunological answer 1 month after antipneumococcal vaccination by the conjugated vaccine Prevenar13 ® in patients suffered from rheumatoid polyarthritis and who begin a treatement by methotrexate either in the same time, either 1 month later.
Patients suffering from rheumatoid polyarthritis have an increased risk to develop an infection compared to general population, with a more important mortality risk because pneumococcus is considered as one of the major pathogenic agents. Antipneumcoccal vaccination is recommended to patients suffering from chronic inflammatory rheumatism treated with immunosuppressants. Methotrexate is a long term treatment used in first intention for rheumatoid polyarthritis. A recent study shows a decrease of efficacity of antipneumoccal vaccination for patients suffering from rheumatoid polyarthritis treated by methotrexate. The tested hypothesis will be the presence of better vaccinal protection for patients suffered from rheumatoid polyarthritis after 1 month between antipneumococcal vaccination and the initiation of methotrexate. The objective is to compare immunologic response for antipneumococcal vaccination between patients who are vaccinated in the same time of initiation of methotrexate and patients who are vaccinated 1 month before the beginning of the treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
276
Vaccination at the beginning of the study (day 0)
Vaccination 2 months later the beginning of the study NB : Vaccine Pneumo23 has been replaced by equivalent vaccine Pneumovax in September 2017 because of the stop of commercialization of Pneumo23 in France by the pharmaceutical company
concerning immediate group, methotrexate is Initiated in the same time that the antipneumococcal vaccination by prevenar 13
CHU Nord
Amiens, France
CHU Pellegrin
Bordeaux, France
rate of immunological positive answer 1 month after antipneumococcal vaccination by the conjugated vaccine Prevenar13 ® in patients suffering from rheumatoid polyarthritis.
Patient who begins a treatement by methotrexate either in the same time, either 1 month later. An answer will be considered as positive if the patient answers in at least 3 on 5 of interest serotypes.
Time frame: 1 month
Number of patients in each group who will know fully immunological answer to 5 interest serotypes after the first antipneumococcal vaccination (Prevenar13)
Time frame: 1 month
Number of patients in each group who will know an immunological answer to 13 serotypes after the first antipneumococcal vaccination (Prevenar13)
Time frame: 1 month
Number of patients who will know a fully immunological answer (13 serotypes of vaccine) after a antipneumococcal revaccination with Pneumo 23.
Time frame: 3, 6 and 12 months
Number of patients who will suffer from adverse events in relation with the antipneumococcal vaccination
Time frame: up to 12 months
Frequency of occurence of disease spurts from the first vaccination until the end of the study
Time frame: Up to 12 months
occurence of the pneumococcal disease from the first vaccination to the end of the study.
Time frame: 1, 6, 7 and 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
For "period group", methotrexate is Initiated \& month after the antipneumococcal vaccination by prevenar 13
CHU La Cavale Blanche
Brest, France
CHU Montpied
Clermont-Ferrand, France
CHU Bicetre
Le Kremlin-Bicêtre, France
CH Du Mans
Le Mans, France
CHU Dupuytren
Limoges, France
CHU La Conception
Marseille, France
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, France
CHU de Nice - Hôpital L'Archet 1
Nice, France
...and 11 more locations