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| Name | Class |
|---|---|
| Hôpital Cochin | OTHER |
| Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate group | Other | 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 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevenar 13 | Biological | Vaccination at the beginning of the study (day 0) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients in each group who will know fully immunological answer to 5 interest serotypes after the first antipneumococcal vaccination (Prevenar13) | 1 month | |
| Number of patients in each group who will know an immunological answer to 13 serotypes after the first antipneumococcal vaccination (Prevenar13) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques MOREL, PU-PH | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nord | Amiens | 80054 | France | |||
| CHU Pellegrin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40749694 | Derived | Morel J, Dernis E, Roux C, Richez C, Brocq O, Fautrel B, Salliot C, Vittecoq O, Mariette X, Liote F, Lassoued S, Gaujoux-Viala C, Constantin A, Soubrier M, Devauchelle-Pensec V, Goeb V, Gottenberg JE, Marotte H, Moulard AR, Daien C, Mouterde G, Lukas C, Pissarra J, Huguet H, Launay O, Galtier F, Picot MC; I-REIVAC; CRI-IMIDIATE French Clinical Research Networks. Effect of a 1-month methotrexate delay on pneumococcal vaccine immunogenicity and disease control in patients with early rheumatoid arthritis (VACIMRA): an open-label randomised trial. Lancet Rheumatol. 2025 Oct;7(10):e675-e686. doi: 10.1016/S2665-9913(25)00071-2. Epub 2025 Jul 29. |
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| Pneumo23 / Pneumovax | Biological | 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 |
|
|
| Methotrexate - Immediate | Drug | concerning immediate group, methotrexate is Initiated in the same time that the antipneumococcal vaccination by prevenar 13 |
|
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| Methotrexate - Delay | Drug | For "period group", methotrexate is Initiated & month after the antipneumococcal vaccination by prevenar 13 |
|
|
| 1 month |
| 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 |
| Number of patients who will suffer from adverse events in relation with the antipneumococcal vaccination | up to 12 months |
| Frequency of occurence of disease spurts from the first vaccination until the end of the study | Up to 12 months |
| occurence of the pneumococcal disease from the first vaccination to the end of the study. | 1, 6, 7 and 12 months |
| Bordeaux |
| 33000 |
| France |
| CHU La Cavale Blanche | Brest | 29609 | France |
| CHU Montpied | Clermont-Ferrand | 63003 | France |
| CHU Bicetre | Le Kremlin-Bicêtre | 94275 | France |
| CH Du Mans | Le Mans | 72000 | France |
| CHU Dupuytren | Limoges | 87042 | France |
| CHU La Conception | Marseille | 13005 | France |
| CHU de Montpellier - Hôpital Lapeyronie | Montpellier | 34295 | France |
| CHU de Nice - Hôpital L'Archet 1 | Nice | 06202 | France |
| CHU Carémeau | Nîmes | 30029 | France |
| CHU Orléans - Hôpital La Source | Orléans | 45000 | France |
| CHU Saint Antoine | Paris | 75012 | France |
| CHU La Pitié Salpétrière | Paris | 75013 | France |
| CHU de Rennes | Rennes | 35056 | France |
| CHU Bois Guillaume | Rouen | 76031 | France |
| CHU Saint Etienne - Hôpital Nord | Saint-Etienne | 42055 | France |
| CHU Hautepierre | Strasbourg | 67098 | France |
| CHU Purpan | Toulouse | 31059 | France |
| CHU Trousseau | Tours | 37044 | France |
| CHPG Monaco - Hôpital Prince Grace de Monaco | Monaco | 98000 | Monaco |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C538862 | 13-valent pneumococcal vaccine |
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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