Vaccination Against Pneumococcal in Naïve Abatacept Rheumatoid Arthritis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-03

Study Completion Date

2021-01-18

Brief Summary

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Is pneumococcal conjugate vaccine (which induces a T-dependent humoral response) more efficient than pneumococcal polysaccharide vaccine (which induces a T-independent humoral response) in RA patients treated with abatacept, biotherapy targeting T-cells? The investigator propose to conduct a prospective, multicenter (11 centers), randomized, open-label study.

The patients are going to be randomized in 2 groups: patients of the first group will be vaccinated with the polysaccharide pneumococcal vaccine (Pneumo23®/Pneumovax®) whereas patients of the second group will be vaccinated with conjugate pneumococcal vaccine (Prevenar13®).

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Detailed Description

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The study population will be all the RA patients between 18 and 85 years with instauration of a treatment by sub-cutaneous abatacept in association with methotrexate who agreed to participate to the study.

At the time of their inclusion, patients will be randomized for receiving either pneumococcal polysaccharide vaccine (PPSV) or pneumococcal conjugate vaccine (PCV).

The primary endpoint will be evaluated at one month after vaccination. The total of follow-up will be of 12 months.

For the patients of the group PCV, the prime-boost strategy will be applied in order to be in accordance with the current French recommendation and a revaccination at 2 months after the initial vaccine will be realized with PPSV.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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pneumococcal polysaccharide vaccine

Patients are vaccinated vith Peumo23/Pneumovax on the first day. Abatacept started on frst day.

Group Type ACTIVE_COMPARATOR

pneumococcal polysaccharide vaccine

Intervention Type BIOLOGICAL

Vaccination with PPSV on first day. NB : PPSV vaccine Pneumo23 has been replaced in September 2017 by the equivalent vaccine Pneumovax because of the stop of commercialization of Pneumo23 in France by the pharmaceutical company.

Abatacept

Intervention Type DRUG

Abatacept started on frst day

pneumococcal conjugate vaccine

Patients are vaccinated with Prevenar13 on the first day, and with Pneumo23/Pneumovax two months later.

Abatacept started on frst day.

Group Type ACTIVE_COMPARATOR

pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Patients are vaccinated with Prevenar13 on the first day, and with Pneumo23/Pneumovax two months later.

Abatacept

Intervention Type DRUG

Abatacept started on frst day

Interventions

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pneumococcal polysaccharide vaccine

Vaccination with PPSV on first day. NB : PPSV vaccine Pneumo23 has been replaced in September 2017 by the equivalent vaccine Pneumovax because of the stop of commercialization of Pneumo23 in France by the pharmaceutical company.

Intervention Type BIOLOGICAL

pneumococcal conjugate vaccine

Patients are vaccinated with Prevenar13 on the first day, and with Pneumo23/Pneumovax two months later.

Intervention Type BIOLOGICAL

Abatacept

Abatacept started on frst day

Intervention Type DRUG

Other Intervention Names

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Pneumo23/Pneumovax Prevenar13 Orencia

Eligibility Criteria

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Inclusion Criteria

* RA according to American College of Rheumatology (ACR)/European League Against rheumatism (EULAR) 2010 criteria
* Disease Activity Score (DAS) 28 ≥ 3.2
* Initiation of a treatment by sub-cutaneous abatacept in combination with methotrexate (MTX), whatever treatment they were receiving before (apart from rituximab (RTX) in the last year)
* Patient has signed study consent form

Exclusion Criteria

* age \< 18 or \> 85 year
* dementia
* patients subjects to legal protection measures
* Corticosteroids ≥ 10mg/d the day of inclusion
* Patient who had a pneumococcal vaccination in the previous 3 years
* Last pneumococcal vaccination \< 3 year
* rituximab in the last year
* History of anaphylactic response to a vaccination
* Contraindications to abatacept or methotrexate
* Pregnancy or pregnancy wish
* Breast feeding
* Patient who currently abuse drugs or alcohol
* Subject who have received any live vaccines within 3 months of the anticipated first dose of study medication.
* Subject who have receive any vaccine within 1 month of the anticipated first dose of the study medication and for all the duration of the study
* Patient with contraindication to intramuscular injections
* Subject with respiratory insufficiency
* Subject at risk for Tuberculosis.
* Blood transfusion within the 3 months previous to the study and for all the duration of the study.
* Concomitant biologic disease-modifying antirheumatic drug (DMARD)
* Within 4 weeks of receiving treatment with any investigational drug.
* Patient positive for hepatitis B surface antigen
* Patient who are positive for hepatitis C antibody if the presence of hepatitis C virus was also shown with polymerase chain reaction or recombinant immunoblot assay.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No