VACcination In Methotrexate Treated Rheumatoid Arthritis Patients
NCT ID: NCT01942174
Last Updated: 2020-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
276 participants
INTERVENTIONAL
2013-09-27
2019-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Immediate group
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
Prevenar 13
Vaccination at the beginning of the study (day 0)
Pneumo23 / Pneumovax
Vaccination 2 months later the beginning of the study NB : Vaccine Pneumo23 has been replaced by equivalent vaccine Pneumovax in September 2017 because of the stop of commercialization of Pneumo23 in France by the pharmaceutical company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
concerning immediate group, methotrexate is Initiated in the same time that the antipneumococcal vaccination by prevenar 13
period group
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
Prevenar 13
Vaccination at the beginning of the study (day 0)
Pneumo23 / Pneumovax
Vaccination 2 months later the beginning of the study NB : Vaccine Pneumo23 has been replaced by equivalent vaccine Pneumovax in September 2017 because of the stop of commercialization of Pneumo23 in France by the pharmaceutical company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 - Delay
For "period group", methotrexate is Initiated \& month after the antipneumococcal vaccination by prevenar 13
Interventions
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Prevenar 13
Vaccination at the beginning of the study (day 0)
Pneumo23 / Pneumovax
Vaccination 2 months later the beginning of the study NB : Vaccine Pneumo23 has been replaced by equivalent vaccine Pneumovax in September 2017 because of the stop of commercialization of Pneumo23 in France by the pharmaceutical company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
concerning immediate group, methotrexate is Initiated in the same time that the antipneumococcal vaccination by prevenar 13
Methotrexate - Delay
For "period group", methotrexate is Initiated \& month after the antipneumococcal vaccination by prevenar 13
Other Intervention Names
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Eligibility Criteria
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Inclusion 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Hôpital Cochin
OTHER
Pfizer
INDUSTRY
University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Jacques MOREL, PU-PH
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Montpellier
Locations
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CHU Nord
Amiens, , France
CHU Pellegrin
Bordeaux, , France
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
CHU Carémeau
Nîmes, , France
CHU Orléans - Hôpital La Source
Orléans, , France
CHU Saint Antoine
Paris, , France
CHU La Pitié Salpétrière
Paris, , France
CHU de Rennes
Rennes, , France
CHU Bois Guillaume
Rouen, , France
CHU Saint Etienne - Hôpital Nord
Saint-Etienne, , France
CHU Hautepierre
Strasbourg, , France
CHU Purpan
Toulouse, , France
CHU Trousseau
Tours, , France
CHPG Monaco - Hôpital Prince Grace de Monaco
Monaco, , Monaco
Countries
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References
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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.
Other Identifiers
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9144
Identifier Type: -
Identifier Source: org_study_id
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