VACcination In Methotrexate Treated Rheumatoid Arthritis Patients (VACIMRA)

University Hospital Center (CHU)

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Biological: Pneumo23 / Pneumovax; Biological: Prevenar 13; Drug: Methotrexate - Immediate; Drug: Methotrexate - Delay

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01942174

9144 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 276 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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276 participants in 2 patient groups

Immediate group

Other group

Description:

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

Treatment:

Drug: Methotrexate - Immediate

Biological: Prevenar 13

Biological: Pneumo23 / Pneumovax

period group

Experimental group

Description:

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

Treatment:

Drug: Methotrexate - Delay

Biological: Prevenar 13

Biological: Pneumo23 / Pneumovax