VACcination In Methotrexate Treated Rheumatoid Arthritis Patients
- Conditions
- Rheumatoid Arthritis
- Interventions
- Biological: Prevenar 13Biological: Pneumo23 / Pneumovax
- Registration Number
- NCT01942174
- Lead Sponsor
- University Hospital, Montpellier
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 276
- Adult (>18 yeas old) suffers from rheumatoid arthritis considering ACR/EULAR 2010 criteria
- Rheumatoid arthritis considering 3,2<DAS<5,1
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description period group Methotrexate - Delay Methotrexate treatment is initiated 1 month later the first antipneumococcal vaccination by Prevenar13. A revaccination by Pneumo23/Pneumovax is administred 2 months after the first vaccination Interventions : biological/vaccine and drug period group Prevenar 13 Methotrexate treatment is initiated 1 month later the first antipneumococcal vaccination by Prevenar13. A revaccination by Pneumo23/Pneumovax is administred 2 months after the first vaccination Interventions : biological/vaccine and drug Immediate group Prevenar 13 For these patients, the methotrexate treatment is initiated in the same time that the antipneumococcal vaccination by Prevenar13. A revaccination by Pneumo23/Pneumovax is administred 2 months after the first vaccination. Interventions : biological/vaccine and drug Immediate group Pneumo23 / Pneumovax For these patients, the methotrexate treatment is initiated in the same time that the antipneumococcal vaccination by Prevenar13. A revaccination by Pneumo23/Pneumovax is administred 2 months after the first vaccination. Interventions : biological/vaccine and drug period group Pneumo23 / Pneumovax Methotrexate treatment is initiated 1 month later the first antipneumococcal vaccination by Prevenar13. A revaccination by Pneumo23/Pneumovax is administred 2 months after the first vaccination Interventions : biological/vaccine and drug Immediate group Methotrexate - Immediate For these patients, the methotrexate treatment is initiated in the same time that the antipneumococcal vaccination by Prevenar13. A revaccination by Pneumo23/Pneumovax is administred 2 months after the first vaccination. Interventions : biological/vaccine and drug
- Primary Outcome Measures
Name Time Method rate of immunological positive answer 1 month after antipneumococcal vaccination by the conjugated vaccine Prevenar13 ® in patients suffering from rheumatoid polyarthritis. 1 month 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.
- Secondary Outcome Measures
Name Time Method Number of patients in each group who will know an immunological answer to 13 serotypes after the first antipneumococcal vaccination (Prevenar13) 1 month Frequency of occurence of disease spurts from the first vaccination until the end of the study Up to 12 months Number of patients in each group who will know fully immunological answer to 5 interest serotypes after the first antipneumococcal vaccination (Prevenar13) 1 month occurence of the pneumococcal disease from the first vaccination to the end of the study. 1, 6, 7 and 12 months Number of patients who will suffer from adverse events in relation with the antipneumococcal vaccination up to 12 months Number of patients who will know a fully immunological answer (13 serotypes of vaccine) after a antipneumococcal revaccination with Pneumo 23. 3, 6 and 12 months
Trial Locations
- Locations (21)
CHU Dupuytren
🇫🇷Limoges, France
CHU La Conception
🇫🇷Marseille, France
CH Du Mans
🇫🇷Le Mans, France
CHPG Monaco - Hôpital Prince Grace de Monaco
🇲🇨Monaco, Monaco
CHU Saint Antoine
🇫🇷Paris, France
CHU Purpan
🇫🇷Toulouse, France
CHU Orléans - Hôpital La Source
🇫🇷Orléans, France
CHU Bois Guillaume
🇫🇷Rouen, France
CHU La Pitié Salpétrière
🇫🇷Paris, France
CHU Pellegrin
🇫🇷Bordeaux, France
CHU Carémeau
🇫🇷Nîmes, France
CHU de Rennes
🇫🇷Rennes, France
CHU Trousseau
🇫🇷Tours, France
CHU Nord
🇫🇷Amiens, France
CHU de Nice - Hôpital L'Archet 1
🇫🇷Nice, France
CHU Hautepierre
🇫🇷Strasbourg, France
CHU La Cavale Blanche
🇫🇷Brest, France
CHU Montpied
🇫🇷Clermont-Ferrand, France
CHU Bicetre
🇫🇷Le Kremlin Bicetre, France
CHU de Montpellier - Hôpital Lapeyronie
🇫🇷Montpellier, France
CHU Saint Etienne - Hôpital Nord
🇫🇷Saint Etienne, France