VACcination In Methotrexate Treated Rheumatoid Arthritis Patients

Rheumatoid Arthritis Clinical Trial

— VACIMRA  

Official title:

Lead Time of the Methotrexate Establishment and Vaccinal Protection Against the Pneumococcal Agent in Patients Affected With Rheumatoid Polyarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01942174
• Other study ID #: 9144
• Status: Completed
• Phase: Phase 3
• Start date: September 27, 2013
• Est. completion date: July 10, 2019

Study information

• Verified date: July 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: July 10, 2019
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• 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

Drug:
• 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

Locations

Country	Name	City	State
France	CHU Nord	Amiens
France	CHU Pellegrin	Bordeaux
France	CHU La Cavale Blanche	Brest
France	CHU Montpied	Clermont-Ferrand
France	CHU Bicetre	Le Kremlin Bicetre
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 La Pitié Salpétrière	Paris
France	CHU Saint Antoine	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
Monaco	CHPG Monaco - Hôpital Prince Grace de Monaco	Monaco

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Hôpital Cochin, Pfizer

Countries where clinical trial is conducted

France,  Monaco, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of patients in each group who will know fully immunological answer to 5 interest serotypes after the first antipneumococcal vaccination (Prevenar13)		1 month
Secondary	Number of patients in each group who will know an immunological answer to 13 serotypes after the first antipneumococcal vaccination (Prevenar13)		1 month
Secondary	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
Secondary	Number of patients who will suffer from adverse events in relation with the antipneumococcal vaccination		up to 12 months
Secondary	Frequency of occurence of disease spurts from the first vaccination until the end of the study		Up to 12 months
Secondary	occurence of the pneumococcal disease from the first vaccination to the end of the study.		1, 6, 7 and 12 months