Clinical trial NCT01942174: VACcination In Methotrexate Treated Rheumatoid Arthritis Patients
Official title: Lead Time of the Methotrexate Establishment and Vaccinal Protection Against the Pneumococcal Agent in Patients Affected With Rheumatoid Polyarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Antipneumococcal vaccination
Methotrexate treatment
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Hôpital Cochin
name: Pfizer
First posted: 2013-09-13
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

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

Primary outcomes:
measure: rate of immunological positive answer 1 month after antipneumococcal vaccination by the conjugated vaccine Prevenar13 ® in patients suffering from rheumatoid polyarthritis.
timeFrame: 1 month
Secondary outcomes:
measure: Number of patients in each group who will know fully immunological answer to 5 interest serotypes after the first antipneumococcal vaccination (Prevenar13)
timeFrame: 1 month
measure: Number of patients in each group who will know an immunological answer to 13 serotypes after the first antipneumococcal vaccination (Prevenar13)
timeFrame: 1 month
measure: Number of patients who will know a fully immunological answer (13 serotypes of vaccine) after a antipneumococcal revaccination with Pneumo 23.
timeFrame: 3, 6 and 12 months
measure: Number of patients who will suffer from adverse events in relation with the antipneumococcal vaccination
timeFrame: up to 12 months
measure: Frequency of occurence of disease spurts from the first vaccination until the end of the study
timeFrame: Up to 12 months
measure: occurence of the pneumococcal disease from the first vaccination to the end of the study.
timeFrame: 1, 6, 7 and 12 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Nord
city: Bordeaux
country: France
facility: CHU Pellegrin
city: Brest
country: France
facility: CHU La Cavale Blanche
city: Clermont-Ferrand
country: France
facility: CHU Montpied
city: Le Kremlin Bicetre
country: France
facility: CHU Bicetre
city: Le Mans
country: France
facility: CH Du Mans
city: Limoges
country: France
facility: CHU Dupuytren
city: Marseille
country: France
facility: CHU La Conception
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Lapeyronie
city: Nice
country: France
facility: CHU de Nice - Hôpital L'Archet 1
city: Nîmes
country: France
facility: CHU Carémeau
city: Orléans
country: France
facility: CHU Orléans - Hôpital La Source
city: Paris
country: France
facility: CHU Saint Antoine
city: Paris
country: France
facility: CHU La Pitié Salpétrière
city: Rennes
country: France
facility: CHU de Rennes
city: Rouen
country: France
facility: CHU Bois Guillaume
city: Saint Etienne
country: France
facility: CHU Saint Etienne - Hôpital Nord
city: Strasbourg
country: France
facility: CHU Hautepierre
city: Toulouse
country: France
facility: CHU Purpan
city: Tours
country: France
facility: CHU Trousseau
city: Monaco
country: Monaco
facility: CHPG Monaco - Hôpital Prince Grace de Monaco
Study officials:
affiliation: University Hospital, Montpellier
name: Jacques MOREL, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: