VACcination In Methotrexate Treated Rheumatoid Arthritis Patients

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NCT01942174

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Study Location
CHU Nord
Amiens, , 80054, France
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Adult (>18 yeas old) suffers from rheumatoid arthritis considering ACR/EULAR 2010 criteria

- Rheumatoid arthritis considering 3,2

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE VACcination In Methotrexate Treated Rheumatoid Arthritis Patients
Official Title  ICMJE Lead Time of the Methotrexate Establishment and Vaccinal Protection Against the Pneumococcal Agent in Patients Affected With Rheumatoid Polyarthritis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Biological: Prevenar 13
    Vaccination at the beginning of the study (day 0)
    Other Name: Antipneumococcal vaccination
  • Biological: 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
    Other Name: Antipneumococcal vaccination
  • Drug: Methotrexate - Immediate
    concerning immediate group, methotrexate is Initiated in the same time that the antipneumococcal vaccination by prevenar 13
    Other Name: conventional methotrexate treatment
  • Drug: Methotrexate - Delay
    For "period group", methotrexate is Initiated & month after the antipneumococcal vaccination by prevenar 13
    Other Name: Experimental methotrexate treatment
Study Arms  ICMJE
  • Immediate group

    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

    Interventions:
    • Biological: Prevenar 13
    • Biological: Pneumo23 / Pneumovax
    • Drug: Methotrexate - Immediate
  • Experimental: period group

    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

    Interventions:
    • Biological: Prevenar 13
    • Biological: Pneumo23 / Pneumovax
    • Drug: Methotrexate - Delay
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2013)		276
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 10, 2019
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Monaco
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01942174
Other Study ID Numbers  ICMJE 9144
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE
  • Hôpital Cochin
  • Pfizer
Investigators  ICMJE
Principal Investigator:Jacques MOREL, PU-PHUniversity Hospital, Montpellier
PRS Account University Hospital, Montpellier
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP