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VACcination In Methotrexate Treated Rheumatoid Arthritis Patients (VACIMRA)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Prevenar 13
Pneumo23 / Pneumovax
Methotrexate - Immediate
Methotrexate - Delay
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Antipneumococcal vaccination, Methotrexate treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU Nord
  • CHU Pellegrin
  • CHU La Cavale Blanche
  • CHU Montpied
  • CHU Bicetre
  • CH Du Mans
  • CHU Dupuytren
  • CHU La Conception
  • CHU de Montpellier - Hôpital Lapeyronie
  • CHU de Nice - Hôpital L'Archet 1
  • CHU Carémeau
  • CHU Orléans - Hôpital La Source
  • CHU Saint Antoine
  • CHU La Pitié Salpétrière
  • CHU de Rennes
  • CHU Bois Guillaume
  • CHU Saint Etienne - Hôpital Nord
  • CHU Hautepierre
  • CHU Purpan
  • CHU Trousseau
  • CHPG Monaco - Hôpital Prince Grace de Monaco

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Immediate group

period group

Arm 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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of patients in each group who will know fully immunological answer to 5 interest serotypes after the first antipneumococcal vaccination (Prevenar13)
Number of patients in each group who will know an immunological answer to 13 serotypes after the first antipneumococcal vaccination (Prevenar13)
Number of patients who will know a fully immunological answer (13 serotypes of vaccine) after a antipneumococcal revaccination with Pneumo 23.
Number of patients who will suffer from adverse events in relation with the antipneumococcal vaccination
Frequency of occurence of disease spurts from the first vaccination until the end of the study
occurence of the pneumococcal disease from the first vaccination to the end of the study.

Full Information

First Posted
September 10, 2013
Last Updated
July 30, 2020
Sponsor
University Hospital, Montpellier
Collaborators
Hôpital Cochin, Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01942174
Brief Title
VACcination In Methotrexate Treated Rheumatoid Arthritis Patients
Acronym
VACIMRA
Official Title
Lead Time of the Methotrexate Establishment and Vaccinal Protection Against the Pneumococcal Agent in Patients Affected With Rheumatoid Polyarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 27, 2013 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
July 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Hôpital Cochin, Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Antipneumococcal vaccination, Methotrexate treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
276 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate group
Arm Type
Other
Arm 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
Arm Title
period group
Arm Type
Experimental
Arm 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
Intervention Type
Biological
Intervention Name(s)
Prevenar 13
Other Intervention Name(s)
Antipneumococcal vaccination
Intervention Description
Vaccination at the beginning of the study (day 0)
Intervention Type
Biological
Intervention Name(s)
Pneumo23 / Pneumovax
Other Intervention Name(s)
Antipneumococcal vaccination
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Methotrexate - Immediate
Other Intervention Name(s)
conventional methotrexate treatment
Intervention Description
concerning immediate group, methotrexate is Initiated in the same time that the antipneumococcal vaccination by prevenar 13
Intervention Type
Drug
Intervention Name(s)
Methotrexate - Delay
Other Intervention Name(s)
Experimental methotrexate treatment
Intervention Description
For "period group", methotrexate is Initiated & month after the antipneumococcal vaccination by prevenar 13
Primary Outcome Measure Information:
Title
rate of immunological positive answer 1 month after antipneumococcal vaccination by the conjugated vaccine Prevenar13 ® in patients suffering from rheumatoid polyarthritis.
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Number of patients in each group who will know fully immunological answer to 5 interest serotypes after the first antipneumococcal vaccination (Prevenar13)
Time Frame
1 month
Title
Number of patients in each group who will know an immunological answer to 13 serotypes after the first antipneumococcal vaccination (Prevenar13)
Time Frame
1 month
Title
Number of patients who will know a fully immunological answer (13 serotypes of vaccine) after a antipneumococcal revaccination with Pneumo 23.
Time Frame
3, 6 and 12 months
Title
Number of patients who will suffer from adverse events in relation with the antipneumococcal vaccination
Time Frame
up to 12 months
Title
Frequency of occurence of disease spurts from the first vaccination until the end of the study
Time Frame
Up to 12 months
Title
occurence of the pneumococcal disease from the first vaccination to the end of the study.
Time Frame
1, 6, 7 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques MOREL, PU-PH
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Nord
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Pellegrin
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
CHU La Cavale Blanche
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
CHU Montpied
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
CHU Bicetre
City
Le Kremlin Bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
CH Du Mans
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
CHU Dupuytren
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
CHU La Conception
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
CHU de Montpellier - Hôpital Lapeyronie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU de Nice - Hôpital L'Archet 1
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
CHU Carémeau
City
Nîmes
ZIP/Postal Code
30029
Country
France
Facility Name
CHU Orléans - Hôpital La Source
City
Orléans
ZIP/Postal Code
45000
Country
France
Facility Name
CHU Saint Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
CHU La Pitié Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
CHU de Rennes
City
Rennes
ZIP/Postal Code
35056
Country
France
Facility Name
CHU Bois Guillaume
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
CHU Saint Etienne - Hôpital Nord
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
CHU Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
CHU Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHU Trousseau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
CHPG Monaco - Hôpital Prince Grace de Monaco
City
Monaco
ZIP/Postal Code
98000
Country
Monaco

12. IPD Sharing Statement

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VACcination In Methotrexate Treated Rheumatoid Arthritis Patients

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