VACcination In Methotrexate Treated Rheumatoid Arthritis Patients
VACIMRA
Lead Time of the Methotrexate Establishment and Vaccinal Protection Against the Pneumococcal Agent in Patients Affected With Rheumatoid Polyarthritis
1 other identifier
interventional
276
2 countries
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 rheumatoid-arthritis
Started Sep 2013
Longer than P75 for phase_3 rheumatoid-arthritis
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2013
CompletedFirst Posted
Study publicly available on registry
September 13, 2013
CompletedStudy Start
First participant enrolled
September 27, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 10, 2019
CompletedAugust 3, 2020
July 1, 2020
4.8 years
September 10, 2013
July 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
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)
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
- +1 more secondary outcomes
Study Arms (2)
Immediate group
OTHERFor 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
EXPERIMENTALMethotrexate 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
Interventions
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
For "period group", methotrexate is Initiated \& month after the antipneumococcal vaccination by prevenar 13
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Participation with an other clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Montpellierlead
- Hôpital Cochincollaborator
- Pfizercollaborator
Study Sites (21)
CHU Nord
Amiens, 80054, France
CHU Pellegrin
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
Related Publications (1)
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.
PMID: 40749694DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacques MOREL, PU-PH
University Hospital, Montpellier
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 10, 2013
First Posted
September 13, 2013
Study Start
September 27, 2013
Primary Completion
August 1, 2018
Study Completion
July 10, 2019
Last Updated
August 3, 2020
Record last verified: 2020-07