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Rheumatoid Arthritis | VACcination In Methotrexate Treated Rheumatoid Arthritis Patients

Rheumatoid Arthritis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Rheumatoid Arthritis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Biological:Prevenar 13Vaccination at the beginning of the study (day 0)

Biological:Pneumo23 / PneumovaxVaccination 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

Drug:Methotrexate - Immediateconcerning immediate group, methotrexate is Initiated in the same time that the antipneumococcal vaccination by prevenar 13

Drug:Methotrexate - Delay

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Immediate groupFor 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 groupMethotrexate 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

Study Status

Recruiting

Start Date: September 27, 2013

Completed Date: September 2019

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: rate of immunological positive answer 1 month after antipneumococcal vaccination by the conjugated vaccine Prevenar13 ® in patients suffering from rheumatoid polyarthritis.

Secondary Outcome: Number of patients in each group who will know fully immunological answer to 5 interest serotypes after the first antipneumococcal vaccination (Prevenar13)

Study sponsors, principal investigator, and references

Principal Investigator: Jacques MOREL, PU-PH

Lead Sponsor: University Hospital, Montpellier

Collaborator: Cochin Hospital, India

More information:https://clinicaltrials.gov/show/NCT01942174

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