VACcination In Methotrexate Treated Rheumatoid Arthritis Patients

• Status: Completed
• Trial end date: 2019-07-10
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Montpellier
• Collaborators: Cochin Hospital; Hôpital Cochin; Pfizer
• Treatments: Heptavalent Pneumococcal Conjugate Vaccine; Methotrexate; Vaccines

Criteria

Inclusion Criteria:

• Adult (>18 yeas old) suffers from rheumatoid arthritis considering ACR/EULAR 2010 criteria

• Rheumatoid arthritis considering 3,2- Patient did not treat by long term treatment or has stopped a treatment by sulfasalazine, hydroxychloroquine or methotrexate for at least 3 months

• Patient has never treated by biotherapy

• Patient has never vaccinated against pneumococcal

• Patient has signed study consent form

Exclusion Criteria:

• Patient has ever treated by leflunomide or has treated previously by leflunomide (last 3 months)

• Patient is currently treated by methotrexate or has treated previously by methotrexate (last 3 months)

• Contraindication to methotrexate: renal insuffisance, alcoolic, chronic hepatisis, infectious condition, AIDS, hematological failure (cytopeny), pregnancy, obesity, diabet, respiratory disease, gastric ulcer

• Contraindication to corticotherapy

• Pregnancy or pregancy wish

• Nursing

• Absence of oral contraception for women of childbearing age

• Patient of age protected by law et deprived of liberty

• Subject who refuses to be vaccinated against pneumococcis agent

• Previous history of vaccination allergy (anaphylactic shok, Quincke oedema...)

• Gluten hypersensivity or intolerance

• Other vaccination during the last month before inclusion

• Ig perfusion during the last 3 months period before the study inclusion or during the study duration

• Patient currently treated by anticoagulant or has not been stopped for at least 48h before the study inclusion or hemostasis failure which is contraindicated with muscular injection

• Participation with an other clinical trial